Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study

Contemporary Clinical Trials 76 (2019) 112–119

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Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study

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Jeanne M. Hoffmana, , Dawn M. Ehdeb, Sureyya Dikmenb,d, Tiara Dillworthb, Kevin Gertzb, Carrie Kincaidc, Sylvia Lucasd, Nancy Temkinb,d, Kate Sawyere, Rhonda Williamsa,c a

Department of Rehabilitation Medicine, Box 356490, University of Washington, Seattle, Washington 98195-6490, USA Department of Rehabilitation Medicine, Box 359612, University of Washington, Seattle, Washington 98104, USA VA Puget Sound Healthcare System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, USA d Department of Neurological Surgery, Box 359924, University of Washington, Seattle, Washington 98104, USA e Department of Psychology, Western Washington Medical Group, 3525 Colby Ave, Suite 200, Everett, WA 98201, USA b c

A R T I C LE I N FO

A B S T R A C T

Keywords: Traumatic brain injury, TBI Cognitive behavioral therapy, CBT Chronic pain Pain interventions

Background and objectives: Chronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI. Methods: Veterans with a history of TBI and chronic pain of at least six months duration (N = 160) will be randomized to either T-CBT or a telephone-delivered pain psychoeducational active control condition (T-Ed). The eight-week T-CBT intervention builds on other efficacious CBT interventions for chronic pain in the general population but is novel in that it is conducted via telephone and adapted for Veterans with a history of TBI. Outcome variables will be collected pre, mid-, and post-treatment, and 6 months following randomization (follow-up). Projected outcomes: In addition to evaluating the effects of the interventions on pain intensity (primary outcome), this study will determine their effects on pain interference, sleep, depression, and life satisfaction. We will also examine potential moderators of treatment outcomes such as cognition, PTSD, and alcohol and drug use. This non-pharmacologic one-on-one therapeutic intervention has the potential to reduce pain and painrelated dysfunction, improve access to care, and reduce barriers associated with geography, finances, and stigma, without the negative effects on physical and cognitive performance and potential for addiction as seen with some pharmacologic treatments for pain. This trial is registered at ClinicalTrials.gov, protocol NCT01768650

1. Introduction Chronic pain is well documented in Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) [1,2], with reported rates as high as 81.5% [3]. Chronic pain, defined as

pain lasting beyond the point of healing and for at least 3 months, is also prevalent among Veterans with traumatic brain injury (TBI) of all levels of severity [4]. In a review of 23 studies on chronic pain after TBI, including both civilians and combatants, 57.8% reported chronic headache [5]. Other studies have shown high rates of chronic

Abbreviations: CBT, Cognitive Behavioral Therapy; CONSORT, Consolidated Standards of Reporting Trials; OEF/OIF/OND, Operations Enduring Freedom, Iraqi Freedom, and New Dawn; PNS, Polytrauma Network Site; PTSD, Post traumatic stress disorder; TBI, Traumatic brain injury; T-CBT, Telephone-delivered Cognitive Behavioral Treatment; T-Ed, Telephone-delivered pain psychoeducation; VAPSHCS, Veterans Administration Puget Sound Health Care System; VHA, Veterans Healthcare Administration ⁎ Corresponding author. E-mail addresses: [email protected] (J.M. Hoffman), [email protected] (D.M. Ehde), [email protected] (S. Dikmen), [email protected] (T. Dillworth), [email protected] (K. Gertz), [email protected] (C. Kincaid), [email protected] (S. Lucas), [email protected] (N. Temkin), [email protected] (R. Williams). https://doi.org/10.1016/j.cct.2018.12.004 Received 2 August 2018; Received in revised form 29 November 2018; Accepted 10 December 2018 Available online 13 December 2018 1551-7144/ © 2018 Published by Elsevier Inc.

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treatment (primary endpoint). 2. We will determine the efficacy of the T-CBT relative to T-Ed in reducing pain interference, sleep problems, and depression, as well as life satisfaction after treatment. 3. We will determine whether treatment effects are maintained at 6 months after randomization (approximately 3 months after treatment conclusion). 4. A formative evaluation will be conducted concurrently to identify key factors relevant to future dissemination and implementation of the intervention into the VA.

musculoskeletal pain [6] along with headache [7]. For OEF/OIF/OND Veterans, the post-TBI clinical picture is complicated by frequent comorbid conditions, increased likelihood of multiple/repeated TBIs, suboptimal conditions for recovery after each TBI, and the presence of unique risk factors associated with Veteran status and combat zone exposures [8–11]. Among OIF/OEF/OND Veterans with a TBI history, 89% have a psychiatric diagnosis [12]. Additionally, about 75% have insomnia and 70% have a pain diagnosis [13,14]. Chronic pain has a negative impact after TBI. Pain is highly associated with depression after mild TBI [15]. Depression is also significantly related to headache at one year following injury [16]. In 146 prospectively studied patients with moderate to severe TBI, a relationship was found between pain, depression, and social participation, with depression related to poorer participation in those with pain [17]. Pain has also been found to be associated with PTSD where individuals with PTSD report higher levels of pain than those without PTSD [18,19]. Lew and colleagues found high co-occurrence of pain, PTSD, and post-concussive symptoms in Veterans, with 42.1% meeting diagnostic criteria for all 3 disorders concurrently [3]. Cognitive Behavioral Therapy (CBT), an empirically supported and commonly used treatment for chronic pain in the general population [20–22], has been used as both an alternative and an adjunct to pharmacological treatment [23]. CBT includes strategies to prevent and manage pain with the goal of reducing pain intensity as well as painrelated disability [24]. Meta-analyses have shown that CBT is efficacious in reducing pain as well as pain-related disability and distress in a range of pain populations, including those with musculoskeletal pain [25,26], headaches [23], and fibromyalgia [27]. Despite the demonstrated effectiveness of CBT in the general pain population, minimal research has been conducted on the use of CBT for pain in individuals with TBI, although results have been promising from small non-randomized studies in civilian populations with TBI [28] [29]. No randomized controlled trials (RCT) have examined the efficacy of CBT for pain after TBI in military or Veteran populations [30,31]. This protocol describes a randomized controlled trial (RCT) designed to test the efficacy of a telephone-based CBT intervention (TCBT) to treat chronic pain in Veterans with a history of TBI compared to telephone delivered pain education (T-Ed) intervention controlling for time, dose, attention, and other nonspecific therapeutic effects. We chose telephone delivery as it has been effective in reaching people with neurologic conditions in other behavioral intervention studies [32–35] and will allow any Veteran with telephone access who has chronic pain to participate, regardless of location, transportation barriers, or limited access to computers or telehealth technology.

Hypotheses 1. Veterans with a history of TBI who participate in T-CBT for pain will show a significantly greater reduction in average pain intensity from pre-treatment to post-treatment compared to individuals with TBI randomized to T-Ed. 2. Participants in T-CBT will show reductions in pain interference, sleep difficulties, depression, and greater improvements in global impression of change and life satisfaction compared to participants who receive T-Ed. 3. Effects of T-CBT will be maintained or increased at 6 months following randomization. All study methods and procedures have been approved by the Human Subjects Review boards at the University of Washington, the Veterans Administration Puget Sound Health Care System (VAPSHCS), and the study sponsor. The trial was registered on ClinicalTrials.gov on January 14, 2013, NCT01768650. 2.2. Study setting Participants will be enrolled through VAPSHCS, which consists of two large VA Medical Centers approximately 45 miles apart. Though comprised of two campuses, VAPSHCS is conceptualized as a single entity, with a single IRB. VAPSHCS is proximal to seven military bases in the Puget Sound region and is a Polytrauma Network Site (PNS) within the Veterans Healthcare Administration (VHA) Polytrauma System of Care, a national integrated network of specialized rehabilitation programs dedicated to serving Veterans and Service Members with Traumatic Brain Injury (TBI) and polytrauma. Sites designated as PNSs are commonly the primary entry point for rehabilitation services for those who have experienced a TBI of any severity.

2. Methods

2.3. Participants and recruitment methods

2.1. Overview of design

Participants will enter into the study via three methods: clinician referral, medical record review, and self-referral. Clinicians that staff specific PNS clinics will be asked to refer Veterans directly to the study. To identify potential participants via medical record review, research staff will review the medical records of Veterans with appointments in PNS clinics in the last 5 years. Standardized screening forms will be used to identify appropriate candidates and staff will be trained to ensure consistent identification of eligible veterans. Those identified as meeting preliminary inclusion and exclusion criteria will be approached via an approved series of letters and telephone calls. Finally, Veterans may learn of the study via flyers that will be distributed in clinics throughout both VAPSHCS divisions and self-refer. Prospective participants will be screened by research staff members to determine eligibility. Inclusion and exclusion criteria will be assessed via a combination of medical record review and self-report and reasons for ineligibility will be collected for purposes of adhering to the Consolidated Standards of Reporting Trials (CONSORT) standards [36]. Individuals who are eligible and express an interest in the study will be offered the opportunity to participate. Participation will commence

This single-center two-group randomized (1:1) trial will examine the efficacy of the T-CBT intervention on average pain intensity in the past week (primary outcome), and pain interference, sleep, depression, and life satisfaction (secondary outcomes) relative to the T-Ed intervention. Outcome variables will be collected pre, mid-, and post-treatment (primary endpoint), and 6 months following randomization (follow-up). We will also examine whether the efficacy of the T-CBT intervention is moderated by indicators of cognition, PTSD, and alcohol and drug use. The sample will include up to 160 enrolled Veterans of OEF/OEF/OND with TBI recruited from VAPSHCS. Fig. 1 shows the study's design. The study's specific aims and related hypotheses are: Specific aims 1. In a randomized controlled trial of Veterans with a history of TBI and chronic pain, we will evaluate the efficacy of T-CBT relative to T-Ed for reducing average pain intensity in the past week after 113

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Fig. 1. Overview of Study Design.

assigned treatment and the un-blinded Research Manager can use to send the participants the treatment materials following randomization. The researchers providing oversight and supervision to the clinicians (JH, RW, DE), the clinicians, and the Research Manager will be unblinded to participant assignment. All other researchers and research staff conducting the outcomes assessments will be blinded to condition assignment and will not have access to the randomization assignment or intervention database. Each clinician will be assigned approximately the same number of participants in each treatment arm. A separate database without any information about treatment assignment will be used to track subject appointments so research staff and clinicians may track intervention and assessment appointments concurrently. This will be done to keep research staff who will perform outcome assessments blind to group assignment and assessment schedules synchronized with intervention progress.

with an informed consent process, conducted in person at VAPSHCS. Individuals who decline to participate will be asked to provide a reason for declining the study (for the CONSORT participant flow figure) as well as basic information including age, sex, race, education, employment status, homelessness, marital status, claims status, service connection, deployment to a combat zone and military service/rank, to facilitate comparison between study participants and non-participants. Participants who consent to participate will complete an in-person baseline evaluation, usually as part of the informed consent appointment. All inclusion and exclusion criteria will be assessed via self-report with TBI diagnosis and mental health criteria verified via structured review of the medical record. 2.3.1. Inclusion criteria 1. Diagnosis of TBI of any severity; 2. Most recent TBI must have occurred after onset of OEF in 2001; 3. Average pain intensity in the past month of 4 or above on 0–10 numeric rating scale (moderate pain or above); 4. Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months; 5. Able to read and speak English; 6. Age 18 years or older; 7. Veteran status; 8. Military Service in OEF/OIF/OND (even if not deployed). 9. Able to communicate over the phone (i.e. must be verbal)

This study adapted two existing telephone-delivered interventions for pain from the Telephone Intervention for Pain study, which was developed for use in civilians with neurologic conditions such as multiple sclerosis and spinal cord injury [39,40]. These interventions were adapted to both TBI and a Veteran population by the clinical psychologists involved in the study who have expertise in TBI, Veteran/military culture, and the co-occurring conditions that are common in OEF/OIF/ OND Veterans with TBI.

2.3.2. Exclusion criteria

2.6. Overview of treatment intervention structure and logistics

1. Cognitive impairment that would interfere with ability to engage in the intervention, defined as a score of 5 (out of 10) or below on The Short Portable Mental Status Questionnaire [37] indicating moderate to severe cognitive impairment; 2. Self-reported or observed communication limitations (e.g., severe hearing impairment) that would prevent ability to participate in the telephone-based intervention or assessments; 3. Hospitalization for psychiatric reasons involving psychosis within the past 5 years; 4. Self-reported or medical record diagnosis of primary psychotic or major thought disorder;

Both interventions will consist of eight 60-min sessions conducted by phone over approximately 8–12 weeks (ideally 1 session/week), scheduled at times convenient for participants (including evenings and weekends if necessary). While the timing of sessions will be flexible (more than one per week or skipping weeks to accommodate a participant's schedule), the goal is to complete all 8 sessions within 12 weeks of the first session. Clinicians are given the option of extending the treatment window to 16 weeks for subjects who appear committed to completing all 8 treatment sessions but need additional time due to reasonable barriers to treatment. We will track number of sessions completed. Both interventions will utilize a corresponding clinician manual and participant treatment workbook. The participant workbooks will contain session-specific content to be discussed during the telephone sessions as well as relevant material to be reviewed between sessions. Treatment workbooks for both conditions will include a common first chapter on chronic pain after TBI, including information on the prevalence, characteristics, and types of pain commonly seen in persons with a history of TBI. Intervention content will differ by condition following the common first session. Participants in both treatments will also receive audio-recordings to listen to between sessions, to augment material covered in the interventions. In both interventions the clinician will make brief (< 15 min) telephone calls to participants as booster sessions 2, 6, and 10 weeks after the final 8th session of

2.5. Interventions: telephone-delivered CBT (T-CBT) and telephonedelivered pain education (T-Ed) intervention development

2.4. Randomization and allocation concealment Upon completion of the pre-treatment assessment, participants will be randomly assigned to one of the two interventions. The primary outcome of pain intensity (which occurs over four brief assessments over the phone within a one-week period) needs to occur within 14 days of randomization. Randomization will be blocked and stratified by pain intensity (4–6 vs. 7–10) and co-occurring PTSD (PTSD Checklist – Version 5 (PCL-5) [38] score < 38 vs. ≥38). Randomization assignment will be computer-generated and recorded in a secure intervention database which the clinicians can access to determine each participant's 114

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Table 1 Overview of Session Content for Both Interventions. Session

Cognitive (T-CBT)

Education (T-Ed)

1

Introduction to Study; Review Participant's Pain and Disability History; Mechanisms of Pain; Diaphragmatic Breathing Goal Setting (behavioral activation); Pacing; Controlled Breathing

Introduction to Study; Review Participant's Pain and Disability History; Mechanisms of Pain Education About Pain after TBI (e.g., Physiological Mechanisms, Gate Control Theory, Myths, Acute vs. Chronic Pain) Mood Changes Related to Pain: Recognizing Depression, Anxiety, and PTSD and Increasing Awareness of Treatment Options; Fostering Resilience

2 3

7

Identifying Automatic Thoughts, Emotions, and Reactions Related to Pain; Evaluating Automatic Thoughts Related to Pain; Completion of Thought Records; Autogenic Relaxation Review of Skills and Completion of Thought Records; Additional Techniques For Evaluating Automatic Thoughts; Progressive Muscle Relaxation Review of Skills and Completion of Thought Records; Use of Distraction; Two MiniRelaxation Techniques Review of Skills and Completion of Thought Records; Coping Thoughts; Mindful Thinking; Guided Imagery Coping with Pain Flare Ups

8

Maintenance of Skills & Relapse Prevention

4 5 6

Effects of Pain on Sleep: Normal Sleep and Sleep Disorders; Impact of and Treatment Options for Disrupted Sleep; Review of Sleep Hygiene Education About TBI (Mechanisms of Injury, Management of Post-Concussive Symptoms); Tips For Critically Evaluating Information about TBI Effects of Pain on Activity; Benefits of Participating in Activities; Exercise for Managing Pain Pain and Communication; Improving Communication With Health Care Providers Relationships/Social Support; Community Resources; Treatment Conclusion

Note: In both intervention conditions, Sessions 2–8 will include a review of the information from the past session. The T-CBT intervention will also include goalsetting and behavioral activation in each session, although not listed above.

completion of the treatment.

treatment. The purpose of these calls will be to ask the participant how he/she is doing and answer any questions. New material will not be introduced in these booster sessions. In the follow-up calls, the clinicians will ask the participants in the T-CBT intervention only about their use of CBT cognitive behavioral strategies for managing pain, and assist them in problem solving implementation of skills to address relapses or pain flare-ups. To ensure that participants will have comparable expectations in each intervention assignment, both interventions will be described as “self-management interventions that are routinely delivered separately or as part of pain treatment programs and have been shown to be helpful for persons in whom pain is the primary disability.” The term “active control” will not be used when describing the educational intervention. Participants will be encouraged to expect beneficial effects in both treatment interventions. The clinicians will be educated about the efficacy of both treatments and encouraged to view them as potentially equivalent treatments given equipoise exists for these two treatments. See Table 1 for an overview of content of both interventions.

2.8. Telephone-delivered education (T-Ed) The T-Ed intervention is designed to be a credible intervention comparable to the T-CBT intervention in terms of time, treatment dosing, measurement processes, attention, delivery modality, the nonspecific effects of therapeutic alliance, and the effect of manualized treatment with specific clinician procedures. The content for the T-Ed condition was also adapted from prior studies conducted by investigators in this group, and in prior studies was perceived as a credible and useful treatment. Participants assigned to the education intervention in prior studies reported a high level of satisfaction with the educational intervention [42,43]. The sessions cover a variety of topics, including the definition and mechanisms underlying chronic pain, common pain-related conditions and their treatments (e.g., sleep disturbance, depression, PTSD), communication, and building resilience. See Table 1 below for a complete list of content in the T-Ed condition. To provide an attention control for the relaxation recordings as part of the T-CBT interventions, participants in the T-Ed intervention will be given recordings (DVDs or digital recordings) with reading related to the content of each topic and asked to listen to these between sessions. Participants will be encouraged to ask questions about and discuss the information presented during the telephone sessions. However, they will not be instructed in any specific cognitive behavioral techniques. The use of this active control condition not only provides a credible comparison group but also a useful clinical intervention that will likely be an improvement over current care, mitigating any ethical risk associated with randomization.

2.7. Telephone-delivered cognitive behavioral therapy for chronic pain (TCBT) When used in treating pain, CBT is an evidence-based psychotherapy that focuses on changing how people think (cognitive) and act (behavioral) in response to pain and pain-related stressors [41]. In CBT, people identify and develop skills to change unhelpful thoughts and behaviors. It often includes coping skills such as relaxation (e.g., muscle relaxation, guided imagery, diaphragmatic breathing), cognitive strategies for promoting helpful thinking, distraction, and activity pacing. It also involves learning behavioral activation that increases engagement in meaningful and reinforcing activities despite the presence of pain. The CBT condition will focus on goal setting, behavioral activation, pacing, thought monitoring, coping with pain flare ups, and relaxation skills training. Each T-CBT session will include a brief relaxation exercise practiced over the phone. Participants will be also given recordings (DVDs or digital recordings) of 7 different relaxation exercises and asked to practice relaxation daily. In each session, participants will complete a personal pain self-management plan that includes instructions for the practice and application of new pain management skills between sessions. The sessions include not only instruction in specific techniques but also a review of the self-management plan and rehearsal of the specific techniques over the phone. The participants will be asked to practice the techniques daily throughout treatment and upon

2.9. Clinician training and supervision Interventions will be conducted by either licensed clinical psychologists or by licensed clinical social workers. Prior to leading study interventions, interventionists will be required to review the study materials, review assigned readings to deepen understanding of the content, rehearse sessions via role play, complete peer review of several recorded sessions from each intervention, and participate in weekly group supervision staffed by all clinicians and several research investigators (JH, RW, DE). 2.10. Treatment fidelity procedures Fidelity to treatment content and procedures will be monitored and enhanced throughout the study via a combination of methods. Weekly 115

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alcohol and other drug for substance abuse [50].

group supervision meetings, led by the study PI and co-investigators with expertise in the delivery of the interventions and the study population, will focus on delivery of treatment, including the prevention of clinician drift from the manuals. In addition, the clinicians' voices will be audio recorded for all study intervention sessions and a 10% subset of each study clinician's sessions will be randomly selected for review with formal rating of treatment fidelity using a standardized fidelity checklist. The fidelity rating system assesses components unique to each intervention, components common to both interventions, and proscribed intervention elements (e.g., use of relaxation in a T-Ed session).

2.12. Primary outcome 2.12.1. Average pain intensity in the past week The primary treatment outcome variable will be average pain intensity at post-treatment. Average pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0 means “no pain” and 10 means “pain as bad as you can imagine”, accompanied by the following instructions: “Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours” [51]. This NRS will be administered by research staff via telephone four times within a one-week period during the assessment periods, and the arithmetic mean of the four ratings will be used as the primary outcome measure of average pain level for that week. For those participants where 4 ratings are unavailable we will use all available measures.

2.11. Measures All measures will be administered by research staff blinded to the intervention assignment. Baseline measures (which will include a brief set of neuropsychological measures) will be administered in-person, while all subsequent assessments will be conducted via telephone. All measures, other than the neuropsychological measures administered at pre-treatment, will be self-reported and based on interview. Assessments will be conducted pre- (within 14 days of randomization and beginning treatment), mid-(at 5 weeks post randomization), posttreatment (within 2 weeks of completing treatment, i.e. 8–18 weeks post randomization) and 6 months after randomization. Each assessment will be comprised of up to 4 interviews within a one-week period, during which participants will be called four times by staff and asked to complete ratings of current pain intensity. All other measures assessed at each time point will be administered during these four calls in any way that is convenient for the participant (e.g., questions can be distributed over all four calls, or administered all at once in any of the calls).

2.13. Secondary outcomes All secondary outcomes will be collected during pre-treatment, midtreatment, post-treatment and 6-month telephone assessments, with the exception of the Patient Global Impression of Change scale (not collected during the pre-treatment assessment). 2.13.1. Pain interference To assess pain interference we will use the Pain Interference Scale of the Brief Pain Inventory [51,52]. This scale has shown excellent psychometric properties among persons with pain, in general [51,53] and has also demonstrated its psychometric superiority to other measures of pain interference in disability samples [54–56]. 2.13.2. Sleep difficulties The Insomnia Severity Index [57] will be used to measure sleep difficulties, which are commonly associated with pain, both in the general population and those with TBI [58,59].

2.11.1. Descriptive measures (All measured at baseline only) Demographic information including gender, age, race, ethnicity, education level, employment status, and marital status will be collected. Service history including service connection level, litigation status, branch of service, highest military rank, total number deployments to a combat zone, total number months deployed, type of discharge (honorable, general, medical), combat exposure, and total years of military service will be collected from the participant.

2.13.3. Depression To assess depression, we will use the Patient Health Questionnaire-9 (PHQ-9) [60]. The PHQ-9 not only provides a reliable and valid measure of depression severity, but also yields a DSM-IV criteria-based diagnosis of a depressive disorder [61].

2.11.2. Descriptive pain measures Self-reported information about pain sites (location of pain), number of pain sites, pattern (temporal), duration (time since pain onset), and pain quality will be assessed using the Pain Quality Assessment Scale-R [44]. We will also gather information on treatments for pain utilized in the past 3 months, including medication, and the types of treatment (e.g., massage, acupuncture).

2.13.4. Global impression of change We will use the Patient Global Impression of Change scale [62], a single question which asks participants to rate their improvement with treatment on a 7-point scale that ranges from “very much improved” to “very much worse,” with “no change” as the mid-point. 2.13.5. Life satisfaction We will administer the Satisfaction with Social Roles and Participation portion of the Patient-Reported Outcomes Measurement Information System questionnaire [63].

2.11.3. Cognitive status In order to describe the cognitive function of the participants in the study, we will use NINDS Common Data Elements Outcome Measures for TBI [45]:The Rey Auditory Verbal Learning Test(a measure of episodic memory) [46] and the Processing Speed Index of Wechsler Adult Intelligence Scale-IV (comprised of the Symbol Search and Coding subtests) [47].

2.14. Safety monitoring At each treatment session, study clinicians will ask participants whether they believe they have been affected negatively by any of the treatment procedures. The research team will submit a report twice a year to the study's safety monitor outlining recruitment and enrollment progress, withdrawals, protocol violations/deviations, unanticipated problems and serious adverse events that may have taken place during the review period. The safety monitor, who is independent of the study, will write semi-annual summary reports and make recommendations to the investigators should any concerns arise or corrective actions be required.

2.11.4. Post-traumatic stress disorder The PTSD Checklist (PCL-5) [38] will be used to assess PTSD. The PCL-5 is a self-report measure of PTSD symptoms. Each of the 20 DSM-V symptoms that define PTSD is rated on 5-point Likert scales, yielding a score ranging from 0 to 80. 2.11.5. Alcohol and drug use Alcohol use will be assessed with the Alcohol Use Disorders Identification Test [48] and the Two-Item Conjoint Screen [49] for 116

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will have 80% power to detect a differential treatment effect of 0.78 points on average pain intensity or 15% of the baseline pain intensity of 5.4 observed in that study. The study will have 80% power to detect a difference of 0.62 standard deviations for each of the secondary outcomes (Hypothesis 2) because of the reduced significance level to account for the multiple comparisons for secondary outcomes.

2.15. Data management All data will be collected on paper by a research staff member who will enter that data into the study database. A second research staff member will also enter that data into the computer. Any discrepancies that arise will be resolved by the Research Manager. All paper copies will be kept in secure locked cabinets accessible only by the research team and will be entered into password-protected secure databases on the VA secure network drive.

3. Discussion and conclusions This will be the first RCT of a telephone delivered CBT intervention for Veterans with TBI and pain. While CBT has been used regularly within and outside the VHA to treat chronic pain, it is typically conducted in group treatments or in individual face-to-face therapy which limit the accessibility for Veterans who do not live near a clinic or are unable to meet during regular business hours. The use of the telephone modality to increase access is a unique and innovative way to engage Veterans. While there are a few other studies that have used a telephone modality for pain interventions among people with other conditions, this study will address an important gap in the current treatment literature regarding the efficacy of this modality for individuals with pain and TBI. In addition to being the first RCT to test CBT for chronic pain among those with TBI history, the current study's interventions delivered by telephone may potentially overcome many of the barriers to care in Veterans with chronic pain. In terms of barriers to care among Veterans, cultural norms in the Armed Services (e.g., stoicism, high pain tolerance, and hesitancy to pursue treatment for anything less than “life, limb, or eyesight”) may result in patients not seeking treatment. Second, stigma, fear of jeopardizing one's career, or having to leave ones' unit for treatment can also lead to not seeking treatment for pain in the acute stage. Third, the transition from the Department of Defense to the VHA can be a bewildering process that leaves many new Veterans uncertain about how to access appropriate care. Fourth, experiences with poor pain management in the acute phase of injury may lead Veterans to feel either helpless or unaware of other options for chronic pain management. Fifth, other problems (e.g., absence of income, relationship difficulties, legal problems) commitments (e.g., school/ work), or logistical barriers (e.g., geography) may limit treatmentseeking for chronic pain. Though complementary and integrative treatments for chronic pain, including CBT, are recommended treatments within the VHA, few VHA facilities, have the resources (i.e. staffing levels and specialized knowledge) to make evidence-based treatment for chronic pain widely available. The lack of empirically supported, readily deployable, manualized psychological treatments for pain in those with disabilities may also be a factor. It is not known if individuals with pain and disabilities are offered or have access to psychological interventions for pain. Persons with chronic pain may also be depressed [65], which in turn can lead to pessimism, discouragement, and fatigue that may interfere with accessing or participating in pain treatments. Perceived stigma regarding seeking psychological care [66] may also be a barrier to seeking psychological services for pain; despite efforts to the contrary, this remains a concern for military populations [67]. Although we will be conducting an efficacy trial, several features of our study design are pragmatic and thus will broaden the applicability of the study to adults with TBI and chronic pain in VA and other settings. These will include broad eligibility criteria, excluding only those with severe cognitive impairment and significant psychiatric difficulties, and having treatment delivered by psychologists and social workers, clinicians who are integrated into many VHA settings. We will monitor treatment adherence and will utilize an intent to treat approach for the primary analyses, such that all enrolled participants will be included in the analyses regardless of adherence, making findings more generalizable to a clinical setting. In addition, we will conduct a formative evaluation, which may yield practical information to inform implementation and will engage relevant stakeholders within the VHA

2.16. Statistical methods All analyses will be intent-to-treat. As a preliminary step, we will compare baseline characteristics of the treatment groups using Fisher's Exact or Wilcoxon-Mann-Whitney tests to determine if there are baseline imbalances despite the randomization. We will use a mixed effects linear regression model to test the hypothesis that T-CBT will lead to larger reduction in average pain intensity than the T-Ed intervention. Baseline, mid-treatment and posttreatment values will be the three time points used and time will be considered as a numerical value with effect assumed to be linear. The time by treatment interaction will represent the treatment effect. We will adjust for the diagnosis of PTSD at baseline and for variables that are imbalanced between intervention groups. Treatment, time, baseline PTSD, and any imbalanced baseline characteristics will be considered to be fixed effects, while participant will be considered a random effect. A 2-sided significance level of 0.025 will be used to keep the experimentwise Type I error rate, the overall chance of declaring one treatment more effective if in fact both are equal in effect, below the traditional 0.05. Similar analyses will be performed for secondary outcomes (i.e., measures of pain interference, sleep, depression, and satisfaction with life) to test the second hypothesis that T-CBT will result in greater reduction in secondary outcomes than T-Ed. To account for the multiple comparisons (the primary outcome plus the 4 secondary outcomes at post-treatment and 6 months post-randomization), we will use a significance level of 0.005 for each test based on the Bonferroni correction. We expect the T-CBT intervention to be equally effective regardless of gender, race/ethnicity, baseline cognitive status, depression, PTSD, or alcohol or drug abuse, although the study is not powered to detect small interactions. However, we will examine subgroups based on these variables to ensure there is not a substantial qualitative interaction, i.e. a positive effect in one subgroup but a meaningful negative effect in the other subgroup. We will perform similar analyses on the average pain intensity at 6month follow-up assessment period to test whether the hypothesized improvements in T-CBT group relative to the T-Ed group are maintained. In this case, we will use all 4 assessment time points and consider time as categorical. We will also keep track of the reasons for any missing data points when known, and report these in any published reports. We will use regression-based multiple imputation using baseline and non-missing outcome information to account for missing data. 2.17. Sample size estimates We will enroll 160 participants (80 per group). Assuming a 10% loss-to-follow-up rate, we will have outcome data on 72 participants per intervention. This will ensure the study has 80% power to detect a difference of 0.52 standard deviations for average pain intensity (Hypothesis 1). The difference observed in average pain intensity in a comparison of similar treatments [64] in participants with chronic pain associated with Spinal Cord Injury, Multiple Sclerosis, or limb amputation was 0.52 standard deviations when this study was being designed. The sample size is based on a 2-sample t-test taking this as the true difference. Based on the baseline pain intensity and residual standard deviation of pain intensity estimated from that trial the study 117

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to enhance dissemination. This study will be a collaborative effort between a team of clinicianscientists with expertise in the study interventions and TBI from a large academic medical center, and a team at a large VA medical center. To complete this study, several key arrangements are required. First, collaboration from inception with a site Principal Investigator who is a clinician-scientist embedded in the PNS is essential to facilitate access to and understanding of the Veteran context, the VHA medical record, communication with the clinicians, and management of any human subjects activities. Second, the majority of study staff will be based at VA. In conclusion, the trial of telephone delivered CBT vs. pain education for Veterans with TBI builds upon a broad evidence base for inperson treatment as well as telephone-delivered treatments in other populations. The current trial is innovative in that it is tailored specifically for 1) Veterans, with specific examples and language that will make it more accessible and assist in connecting it to each participants' experience, and 2) for those with TBI, by reducing content and providing multiple methods of engaging with information both in written and verbal formats, as well as using known strategies to assist with recall of important information. If effective, the T-CBT intervention could be disseminated throughout the VHA system and potentially to other military personnel who may have difficulty accessing specialty pain care, either in person or in their local area.

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Funding [22]

This study was funded through a cooperative agreement PT110602 (W81XWH-12-2-0109) with the Congressionally Directed Medical Research Programs of the Department of Defense.

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Acknowledgements

[25]

Research staff who contributed to the study include Juliana Bondzie, M.A., Meredith Jenkins, M.A., Michelle Upham, MSW, Sarah Sullivan-Singh, Ph.D., Jason Barber, MS. Advisory Panel: Lisa McPeak, M.D., Sari Gold, Ph.D. Kathleen Pagulayan, Ph.D. Safety Monitor: Aaron Turner, Ph.D. The Veterans who participated in this study- for their service and whose participation and feedback made this project possible.

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