Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes Among Primary Care Veterans
Phase: NA
Conditions: Musculoskeletal Pain, Pain
Sponsor: VA Office of Research and Development

 
 
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Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes among Primary 
Care Veterans  
 
NCT04724694  
 
10/17/2024 
 
 
 
 
 

 
 
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Background and Significance 
Chronic pain is highly prevalent among primary care Veterans and impacts health and safety.  
Pain has a significant impact on the VA healthcare system with 50% or more of Veterans in primary 
care reporting pain (1-2). Chronic musculoskeletal conditions are among the most common sources of pain 
and are, therefore, the focus of this application. Chronic musculoskeletal pain has been associated with a 
range of disabling health outcomes, including diminished functional status and quality of life as well as 
increased health care costs associated with high rates of medical care utilization (3-5).  Attention to chronic 
pain among Veterans has also increased given its relation to high priority safety issues identified by VA: 
suicide and opioid use. Chronic pain is associated with suicide risk, particularly among those with moderate or 
severe pain intensity (6).  The safety of opioids has also been called into question because of well-documented 
adverse outcomes including substance misuse, accidental poisoning, and death (7). 
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is effective but designed for specialty care.  
The CBT-CP treatment approach is consistent with the biopsychosocial model of pain and targets the 
biological (e.g., relaxation training), psychological (e.g., cognitive coping), and social (e.g., decreasing 
isolation) aspects of pain to improve health outcomes. CBT-CP encourages clients to adopt an active, 
problem-solving approach to cope with the many challenges associated with chronic pain (8). Behavioral 
targets of CBT-CP emphasize activity pacing that helps with re-engaging in pleasurable events (or new 
activities) in a safer manner. Relaxation training is used to directly address the stress associated with chronic 
pain. CBT-CP also targets the maladaptive thoughts that occur in relation to pain. Learning and applying 
thought monitoring, evaluation, and disputation can result in more balanced and useful ways of responding to 
pain and its consequences. Abundant evidence suggests that CBT-CP produces small to moderate 
improvements in important clinical outcomes, including measures of disability (e.g., pain-related activity 
interference), pain intensity, mood (e.g., depression symptoms), and quality of life (9). 
Within the VA system, a protocolized full-length CBT-CP treatment is currently available as part of the 
Evidence-Based Psychotherapy Program which has been shown to be effective at improving pain intensity, 
catastrophic thinking, pain-related activity interference, and overall psychological distress. This protocol is 
typically delivered by behavioral health providers with pain management expertise who work in specialty care 
settings due to its time-intensive nature (i.e., 11-12 sessions of 50-mintues each). Many patients who could 
benefit from CBT-CP never receive it 
due to limited access to specialty 
CBT-CP providers (10). Adding more 
specialty providers is likely beneficial 
to a point, but the sheer volume of 
patients who could benefit from CBT-
CP prohibit specialty care from being 
the chief source of CBT-CP. Thus, 
there has been a suggestion for 
improved integration of behavioral 
treatment into medical settings, such 
as primary care, to reach more 
patients in need.   
Brief CBT-CP provides essential 
components of treatment in less 
time.  
Our team adapted the full-
length protocol into Brief Cognitive 
Behavioral Therapy for Chronic Pain 
(Brief CBT-CP; 11) which is designed 
for use by Primary Care Mental Health 
Integration (PCMHI) providers to 
reduce functional limitations related to pain while conforming to the brief treatment format (≤6, 15-30-minute 
appointments ). Brief CBT-CP is significantly shorter in duration (~3 hours total) than the original protocol (up 
to 12 hours). The resulting manualized protocol for Brief CBT-CP is summarized in Figure 1.  
Preliminary studies: Brief CBT-CP is associated with improvement in patient outcomes.  
Figure 1: Overview of Brief CBT-CP Sessions 
Session Content summary 
1 
Education and Goal Identification: Acute versus 
chronic pain; factors that impact pain/biopsychosocial 
model; chronic pain cycle; SMART goals 
2 
Activities and Pacing: Address fear of movement; 
activities pacing; avoiding withdrawal or 
disengagement 
3 
Relaxation Training: Relaxation benefits and 
techniques (Deep breathing and abbreviated 
progressive muscle relaxation) 
4 
Cognitive Coping 1: Recognize unhelpful thoughts 
that negatively impact the pain experience  
5 
Cognitive Coping 2: Modify thoughts that are 
unhelpful when managing pain 
6 
The Pain Action Plan: Reviewing progress made and 
skills acquired; Plan for future success 

 
 
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We conducted a clinical demonstration project to gather preliminary data regarding Brief CBT-CP 
effectiveness and acceptability among patients and providers (12). Nationally, 22 PCMHI providers across 22 
primary care clinics responded to an invitation to participate in a 12-month demonstration project that included 
training in Brief CBT-CP. At the end of the project period, data from 118 unique patients treated with Brief CBT-
CP by a participating PCMHI provider were analyzed to assess changes in outcomes. Although not a 
randomized controlled trial (RCT), patient reported outcome data collected by the PCMHI providers at each 
visit showed statistically significant improvement in the PEG (13) of moderate effect size by session three (d = 
0.65). This one-point decrease in PEG scores indicated that clinically significant improvement in outcomes can 
potentially be made in as few as three, 30-minute appointments of Brief CBT-CP. Pain self-efficacy showed 
smaller but also statistically significant improvements (d = 0.22).   
Significance and Relevance for Veterans and VA Healthcare 
The long-term goal of this research is to promote recovery among Veterans with chronic 
musculoskeletal pain. The focus of the intervention (i.e., a CBT intervention to improve functional outcomes 
commonly impacted by chronic pain) directly addresses the current RR&D special emphasis area related to 
non-pharmacological activity-based interventions for chronic pain. Taken together, these related high priority 
topics reflect ORD-wide clinical priorities and the VA’s current Strategic Plan (FY19-24). 
Research Design and Methods 
Participants.  
We will recruit and randomize 184 Veterans (not including screening failures) who utilize one of the 
primary care clinics located at the regional VAMC and CBOCs in Western and Central New York. Eligible 
participants will be randomized in a 1:1 ratio into either (1) Brief CBT-CP plus primary care TAU or (2) primary 
care TAU only.  
Eligibility and recruitment.  
Screening procedures. Our primary method of recruiting Veterans with chronic musculoskeletal pain 
who self-report functional impairment will replicate our successful case-finding method. This method has 
proven especially effective in identifying primary care patients with chronic pain of at least moderate intensity 
that could benefit from intervention but who have not otherwise received behavioral treatment for pain. Note 
that we will additionally accept referrals for potential participants directly from the primary care team, should 
they arise or directly from the Veteran by contacting the PI or study staff after hearing of the study by word of 
mouth or other sources, including ClinicalTrials.gov. For case-finding, VA electronic medical record data will be 
initiated to identify potential participants. Based on prior work, we estimate that about 7,000 individuals will 
initially be accessed through VINCI/CPRS from which to do additional screening for initial eligibility criteria: 
Veterans who are age ≥18 and ≤79 years, conversant in English, have an established history of VA primary 
care utilization at the regional VAMC/CBOCs (i.e., at least one primary care visit in the past year), and a 
diagnosis of a musculoskeletal condition based on ICD-10 code linked to their primary care encounter(s). We 
will also remove patients with a diagnosed major or minor neurocognitive disorder (e.g., dementia) based on 
ICD-10 code. Those Veterans meeting initial eligibility criteria will be sent a study invitation letter signed by the 
primary care lead. Following the letter, Veterans will be contacted by phone (after a period of one week to 
allow patients to decline participation, if desired) for additional screening. They are first asked to verify the 
presence of current musculoskeletal pain for ≥ 3 months (consistent with the consensus definition of chronic 
pain from the International Association for the Study of Pain). The PEG (13), a well-validated 3-item composite 
measure of pain intensity and functional impairment, will also be administered. Veterans must score ≥4 on the 
PEG pain intensity item and ≥4 on the PEG pain interference items to verify impact of at least moderate 
intensity. Initial exclusion criteria: Veterans will be excluded if they score positive on the Drug Abuse Screening 
Test (DAST-10). We will exclude those with a positive score on the Alcohol Use Disorders Identification Test 
(AUDIT) which would exclude those with a more significant alcohol use disorder. Veterans will be additionally 
excluded at this stage if they self-report current or prior engagement (in the past 12 months) in behavioral 
health services specifically for chronic pain, such as pain psychology services or behavioral medicine 
interventions, given the potential for overlap in content with Brief CBT-CP. Veterans who are already receiving 
a stable course of on-going mental health services that are not focused on pain (e.g., PCMHI, specialty mental 
health clinic, PTSD clinic, etc.) or psychopharmacological intervention from a mental health prescriber will not 
be excluded. We will ask patients to clarify if they have had any recent changes (last 2 months) in pain 
medication or medications for mental health conditions. Use of over-the-counter (OTC) analgesic 
medications/topicals will not be considered an exclusion criterion, even if these agents are recorded in the 

 
 
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patient’s medical record by a VA provider.  Similarly, routine or PRN use of prescribed anti-inflammatory 
medications (i.e., acetaminophen, aspirin, ibuprofen, naproxen, diclofenac) or topical agents will not be 
considered an exclusion criterion. Veterans who are engaging in interventional procedures for chronic pain 
management (e.g., epidural), have recently had (i.e., in the past three months) or plan to have surgery or other 
hospitalizations, or have a pending pain-related disability claim will be excluded.   
Consenting and baseline assessment. We will aim to conduct all study procedures by phone/VVC as 
the safest option during the pandemic. We have therefore requested a waiver of documentation of informed 
consent and a full HIPAA waiver. Veterans who meet initial telephone screening criteria will be scheduled for 
consenting procedures and a baseline interview to confirm eligibility. We will send potential participants study 
related materials (e.g., baseline appointment reminder letter, informed consent information, etc.) in advance of 
their baseline appointment using secure Azure RMS email, a VA-approved encrypted email, or through 
standard mail. We will also send study measures in advance of the baseline and subsequent assessments 
based on request of the participant or judgment of the study team. Verbal consent will be and a check of 
participant understanding of key consent items will be administered prior to collecting baseline assessment 
data. Our primary outcome, pain-related activity interference, will be assessed with the Brief Pain Inventory 
(BPI) interference subscale. Only those potential participants with a score ≥4 (indicating at least moderate 
pain-related disability) will be included. Potential participants who endorse active suicidal ideation at time of 
assessment will be further evaluated by study staff following a standard suicide risk prevention protocol and 
consultation with study PI (or designee). Individuals who are deemed at elevated risk (e.g., suicidal ideation 
with intent and plan) will be connected to the appropriate emergency service (see Suicide Protocol, including 
warm handoff procedures to Vet’s Crisis Line). Electronic medical record review will be used to confirm 
screening self-report of prescribed pain or psychiatric medications are on a stable dose for the past two 
months. Use of over-the-counter (OTC) analgesic medications/topicals will not be considered an exclusion 
criterion, even if these agents are recorded in the patient’s medical record by a VA provider.  Similarly, routine 
or PRN use of prescribed anti-inflammatory medications (i.e., acetaminophen, aspirin, ibuprofen, naproxen, 
diclofenac) or topical agents will not be considered an exclusion criterion. Patients will be asked to confirm 
medical record information regarding psychotropic medication, such as whether or not medications are 
currently being taken as prescribed. Similarly, chart review will be used to confirm select telephone screening 
items noted above, i.e., that the patient has not 1) used behavioral services for chronic pain management in 
the past 12 months, 2) has no recent (i.e., in the past three months) or upcoming interventional procedures for 
chronic pain management (e.g., epidural), 3) have recently had (i.e., in the past three months) or plan to have 
surgery or other hospitalizations, or 4) have a pending pain-related disability claim. Additionally, patients will be 
excluded if chart review indicates either of the following: 1) unstable psychiatric status (e.g., active psychosis, 
current mania),  2) major or minor neurocognitive disorder (e.g., dementia), or any other illness or condition 
(e.g., active cancer treatment for new diagnosis, end-of-life care, etc.) that would preclude or predictably 
influence ability to appropriately engage in study visits, as determined by the study team. Participants will also 
be excluded if they are unwilling to have their treatment sessions audio recorded. Patients who are excluded at 
this stage due to recent changes in medications, use of mental health services for chronic pain management 
within the past year, or recent/upcoming interventional procedures who otherwise meet all inclusion criteria and 
are interested in participating will be asked if they would like to be re-contacted in the future by study staff 
when appropriate timeframes have passed for re-evaluation of eligibility.  
Procedures.  
Upon completing baseline measures and meeting all eligibility criteria, participants will be randomly 
assigned to (1) Brief CBT-CP plus TAU or (2) TAU only. Assignment to Brief CBT-CP will be stratified based 
on degree of pain interference as measured by the Brief Pain Inventory (14). Participants will be classified as 
moderate interference (mean BPI interference subscale score ≥4 and <7) or severe interference (mean BPI 
interference subscale score ≥7). All participants will complete a follow-up (face-to-face, telephone, or VVC) 
with the study coordinator, who will be blinded to participants’ condition at 12 weeks (post-treatment)  
randomization for re-administration of study measures. On an as-needed basis, we will contact participants 
through telephone, secure Azure RMS email, or through standard mail to provide appointment reminders and 
follow-up in case of missed appointments. Participants will be compensated $50 for the initial assessment and 
$50 for each of three follow ups (total $200).  
 
Measures of Patient Outcomes.  

 
 
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Administration of all study measures below will take about one hour at each time point:   
Brief Pain Inventory (BPI). The BPI is an extensively validated 9-item scale that includes a subscale to 
assess pain-related interference in daily activities and social functioning (14). It is the primary patient outcome 
for this trial. The BPI also includes an assessment of pain intensity which will be used as a secondary 
outcome. Both subscales are considered core outcome measures for pain management effectiveness trials.  
Patient Health Questionnaire-9 (PHQ-9).This is a 9-item measure of depressive symptoms validated for 
use in primary care (15). Respondents are asked to rate symptoms experienced over the past two weeks on a 
four-point scale ranging from not at all (0) to nearly every day (3). The PHQ-9 is included because depression, 
as an indicator of emotional functioning, is a core outcome domain for all pain clinical trials.  
World Health Organization Quality of Life - BREF (WHOQOL-BREF). This 26-item abbreviated version 
of the well-validated, full-length WHOQOL measure evaluates quality of life in several domains such as social 
relationships and satisfaction with person-environment interactions (16). WHOQOL-BREF is included to 
determine if Brief CBT-CP can improve overall quality of life across multiple domains of function.  
Ability to Participate in Social Roles and Activities – Short Form (APSRA-SF). This 8-item measure was 
developed to evaluate one’s perceived ability to perform usual social roles and activities. Negatively worded 
items about social role engagement are rated on a scale from 1 (always) to 5 (never) such that higher scores 
represent fewer limitations. This measure has been shown to have excellent psychometric properties and 
clinical utility (17).  
 Demographics. We will gather participant background information by asking them to self-report 
standard demographic variables (e.g., age, gender, race/ethnicity, income, education, service era, etc.) for 
purposes of describing our sample and for potential effect modifiers (i.e., age and gender).  
Therapist training and assessment of fidelity.  
The interventionists will be trained by the PI in how to apply the protocol. Training will include at least 
20 hours of didactic explanations of the principles of each intervention, role play and feedback exercises, 
discussion of case examples, and skill rehearsal. Following the above training requirements, audio recorded 
sessions will be reviewed from the first three patients assigned to each interventionist during weekly 
supervision to provide additional feedback/instruction based on rating scale scores. As shown in the Brief CBT-
CP Adherence Ratings Scale, critical components are protocol-specific aspects of the intervention related 
directly to psychoeducation or skill development (e.g., describing the biopsychosocial model of pain or 
providing instruction in relaxation training). Non-critical components (e.g., agenda setting, reinforcing at-home 
practice, session length) are important aspects of most CBT-based treatment for the PCMHI setting but are not 
intervention specific and, therefore, do not necessarily adversely impact dose of CBT. If adherence measure 
scores are below cut off, the interventionist will receive feedback and be assigned additional role play/training 
cases until deficiencies are corrected.  
Study conditions. 
Brief CBT-CP plus TAU: In summary, Brief CBT-CP is a manualized protocol that includes six, 30-
minute sessions over the course of 12 weeks. Session one focuses on foundational pain education and the 
development of treatment goals. Session two emphasizes balanced engagement in physical activity and 
pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. 
Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. 
Session six focuses on relapse prevention and independent implementation of CBT-CP skills following 
treatment. Progress across sessions is measured by routine use of the PEG and two items inquiring about 
completing homework and skills practice. These brief items are administered by the study interventionists as 
part of the treatment protocol. Brief CBT-CP will be delivered face-to-face (primary care clinics or reserved 
clinical research space), telephone, or VVC depending on patient preference and safety issues related to 
COVID-19. Patients will be provided with the Brief CBT-CP Patient Guidebook as part of their treatment. 
Sessions will be audio recorded for review by PI or designee for fidelity assessment.  
TAU only: Participants assigned to TAU only will receive standard medical care from their primary care 
provider including pain medications, brief advice (e.g., use of relative rest and self-care strategies), or referral 
to adjunctive interventions (e.g., physical therapy, chiropractic, standard PCMHI, etc.), as indicated.  
Power Analyses. 
 Our primary aim of this longitudinal, two-arm, parallel RCT is to adequately test our primary null 
hypothesis of no differences in pain-related activity inference measured by the BPI Interference (BPI-I) 
subscale between Brief CBT-CP plus TAU and TAU-only across a 12-week treatment period. Multilevel 

 
 
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modeling (MLM) using a random coefficients model will be used to test this hypothesis by assessing the group 
by time fixed effect coefficient. A sample size of 184 (92 per group) offers at least 80% power to detect a small 
to medium effect of .35 in the group by time coefficient with an experiment-wise alpha of .05 (2-tailed).  To 
estimate sample size, we employed the method proposed by Hedeker, et al. for multilevel longitudinal designs 
(18) using results from our Brief CBT-CP clinical demonstration project. Our sample size is adjusted for an 
overall 25% attrition rate split across treatment (12%) and follow-up (13%) study periods. 
Statistical Analysis  
Statistical analyses will be conducted using SAS v9.4. The primary analysis will be conducted using the 
intention-to-treat approach; participants who are randomized will be analyzed according to their assigned 
group regardless of amount of treatment received. The data will be screened for missing cases, outlier scores, 
and non-normal response distributions. Assumptions underlying statistical models will be assessed by 
examining standardized residuals, influence diagnostics, and homogeneity of variance (e.g., among groups).  
A multilevel model (MLM) will be used to test the primary null hypothesis of no difference in pain-related 
activity interference measured by the BPI Interference subscale between Brief CBT-CP plus TAU and TAU-
only against the two-sided alternative. Our MLM will consist of fixed and random effects. Fixed effects will 
consist of group, time of assessment, and a cross-level interaction between condition and time. The condition 
effect compares the baseline BPI-I score between Brief CBT-CP plus TAU and TAU-only. Time will be entered 
in our model as a nominal variable representing effects relative to baseline at weeks. In other words, baseline 
(t0) will be defined as the reference level allowing dummy indicators to estimate differences in BPI-I from 
baseline. The β of the 12-week primary treatment effect will be tested against a two-sided alternative.  
Similar to our primary outcome measure of pain-related activity interference, we intend to utilize MLM to 
assess secondary subjective outcomes (i.e., pain intensity, depression symptoms, suicidal ideation, quality of 
life, and social role engagement). Comparing multiple correlated outcomes on the same set of patients tends to 
inflate the number of incorrect rejections of the null hypothesis. Thus, the Benjamini-Hochberg False Discovery 
Rate (FDR) procedure (19), described in further detail below, will be utilized to preserve the proportion of 
incorrect rejections (among rejected hypotheses) at 5% . 
 
 
 

 
 
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