Chronic PainCPSMINCT04118283
Assessment and Treatment for Chronic Pain in Veterans With Serious Mental Illness
A study testing Cognitive Behavioral Therapy for Chronic Pain and Health and Wellness in people with Chronic Pain and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Schizophrenia, Psychotic Disorders
- What is being tested?
- Cognitive Behavioral Therapy for Chronic Pain and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a chronic musculoskeletal pain diagnosis
- Have a Defense and Veterans Pain Rating Scale (DVPRS) rating of 4 or greater for pain severity
- Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder) per medical record
- 18 years of age or older
- Enrolled in outpatient programming within the VA Maryland Health Care System at time of consent/study reenrollment
- Have regular access to a telephone
- Capacity to sign informed consent
Who cannot join
- Are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by treating provider)
- Engagement in Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past
- Have a current acute pain condition or limited mobility (i.e., unable to walk one city block) that would interfere with their ability to engage in CBT-CP interventions (e.g., activity pacing/walking program)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness
Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.
Read the detailed description
This research study will address critical gaps in our understanding and management of chronic musculoskeletal pain in Veterans with serious mental illness (SMI), addressing the following aims:
Aim 1: Complete a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of CBT-CP and preliminarily evaluate participant responses to intervention.
Aim 1a (Primary): Determine feasibility by demonstrating adequate rates of recruitment and completion of and fidelity to the CBT-CP intervention as well as quality and acceptability of chosen assessments.
Aim 1b (Primary): Determine acceptability by obtaining favorable ratings from satisfaction questionnaires and interviews.
Aim 1c (Exploratory): Preliminarily evaluate participant responses to intervention by exploring changes in functioning and quality of life among Veterans randomized to the CBT-CP condition (n=30).
Aim 2: Determine the feasibility of collecting EMA data to examine the temporal relationships among mental health symptoms, pain severity, and health-related functioning. Data will be collected at baseline from the 45 Veterans in the Aim 1 RCT.
Aim 2b (Primary): Determine feasibility of this approach through adherence to the EMA call schedule and overall response rates.
Aim 2a (Exploratory): Explore relationships among mental health symptoms, pain severity, and health-related functioning captured in real time.
Aim 3: Complete a well-specified process evaluation to explore how to optimize CBT-CP for use in Veterans with SMI and chronic musculoskeletal pain in future clinical trials. This evaluation will integrate qualitative data from 15 interviews with Veterans in the CBT-CP condition, CBT-CP interventionist notes, and quantitative data from Aims 1 and 2.
- Conditions
- Chronic Pain, Schizophrenia, Psychotic Disorders, Bipolar Disorder, Affective Disorders, Psychotic
- Being tested
- Cognitive Behavioral Therapy for Chronic Pain, Health and Wellness
- Keywords
- Veterans, chronic pain, psychotic disorders, affective disorders, psychotic, cognitive behavioral therapy, ecological momentary assessment
- Medical subject headings
- Chronic Pain, Schizophrenia, Psychotic Disorders, Bipolar Disorder, Affective Disorders, Psychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Chronic PainBehavioural
Also called CBT-CP
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan.
Health and WellnessBehavioural
Also called H&W
Health \& Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Chronic Pain | Experimental | Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan. Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Pain |
| Health and Wellness | Active comparator | Health \& Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area. Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Retention and Adherence
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists.
The table below shows outcomes for objective 2a: retention and adherence rates.
Measured: Data will be gathered from each participant through intervention completion, an average of 11 weeks
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Treatment Completion Rates
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists.
The table below shows outcomes for objective 2b: treatment completion rates.
Measured: Data will be gathered from each participant through intervention completion, an average of 11 weeks
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Mean Number of Sessions Completed
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists.
The table below shows outcomes for objective 2c: mean number of sessions attended
Measured: Data will be gathered from each participant through intervention completion, an average of 11 weeks
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Mean Number of Home Practices Completed
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists.
The table below shows outcomes for objective 4: mean number of home practice assignments completed.
Measured: Data will be gathered from each CBT-CP participant through intervention completion, an average of 11 weeks
Participant Satisfaction Questionnaire (CSQ-8)
Participants completed a treatment satisfaction survey at mid-treatment (~session 5) and post-treatment (~session 11) that included the Client Satisfaction Questionnaire-8. The CSQ-8 contains eight Likert scale items that ask about quality of service received and if services have been helpful. Average scores on the CSQ-8 range from 1 (lowest) to 4 (highest), with higher average scores indicating greater satisfaction. This measure was used to assess CBT-CP acceptability via treatment satisfaction surveys (Aim 1b). For analyses, post-treatment CSQ (week 11) was used for treatment completers; mid-point CSQ (week 5) was used for individuals who did not complete a full course of treatment.
Measured: Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11), with overall assessment also reported
Service Satisfaction Scale (SSS-18)
Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11) that included the Service Satisfaction Scale-18 (SSS-18).The SSS-18 has 18 items that assess practitioner manner and skill, perceived outcome, office procedures, and accessibility. An average score was calculated for each participant, ranging from 1 (lowest) to 5 (highest). This measure was used to assess CBT-CP acceptability along with the CSQ-8 (Aim 1b). For analyses, post-treatment SSS-18 (week 11) was used for treatment completers; mid-point SSS-18 (week 5) was used for individuals who did not complete a full course of treatment.
Measured: Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11), with overall assessment also reported
Ecological Momentary Assessment - Feasibility, Completed Surveys
The Ecological Momentary Assessment (EMA) survey included 18 questions about pain severity, pain-related functioning (impact on stress, mood, sleep, activity; DVPRS), and SMI symptoms (depression [PHQ-2], mania [ISS-A], psychosis [BASIS-24]) experienced over the past hour. Pain-related items were derived from validated measures (Defense and Veterans Pain Rating Scale, pain severity and supplemental items) rated on a 0 (no pain/pain interference) to 10 (worst pain/complete interference); the sleep item was only asked once per day. Items from validated mental health symptom measures were used, but response scales were modified to yes/no format (i.e., whether person experienced the symptom in the past hour). Participants received three (3) surveys per day via text message (link to REDCap survey) for seven (7) days (21 total surveys); the first survey was delivered between 8am-12pm, the second between 12pm-4pm, and the third between 4pm-8pm.
Measured: One week, between consent and baseline assessment
Secondary outcomes (10)
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference (Post-Treatment)
The West Haven Yale Multidimensional Pain Inventory (WHYMPI) is a 52-item questionnaire providing a comprehensive assessment of components of the chronic pain experience that are helpful for the cognitive-behavioral conceptualization of chronic pain conditions. Each item is rated on a 7-point scale. The interference subscale (WHYMPI-INT), a 9-item scale, will be used in this study and measures the impact of pain on functioning (household chores, outdoor work, recreation activities, social activities). An average score is calculated that ranges from 0 (no interference) to 6 (extreme interference). The WHYMPI has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The WHYMPI is used as part of the CBT-CP assessment protocol.
Measured: Post-treatment (approximately 12 weeks post-randomization)
Pain Severity (Pain Numeric Rating Scale, PNRS) - Post-Treatment
The Pain Numeric Rating Scale (PNRS) assesses pain severity over the past week based on a 0 (no pain) to 10 (worst pain imaginable) scale. Three items - average pain over the past week, worst pain over the past week, least pain over the past week - are averaged for an overall pain severity score. The PNRS has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The PNRS is used as part of the CBT-CP assessment protocol. Participants will be assessed following completion of the study intervention, an expected average of 11 weeks
Measured: Post-treatment (approximately 12 weeks post-randomization)
Veterans RAND 36-item Health Survey (VR-36) (Post-Treatment)
The Veterans RAND 36-Item Health Survey (VR-36) is a 36-item questionnaire measuring health-related quality of life and 8 domains of health-related functioning (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health). Items are scored on a 3- to 6-point scale and are summed to create each of the domain scores, ranging from 0 (worst health status) to 100 (best health status). The VR-36 demonstrated improved reliability, precision, and validity compared to the SF-36 and among persons with SMI.
Measured: Post-treatment (approximately 12 weeks post-randomization)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - Post-Treatment
The WHODAS 2.0 is a 36-item questionnaire assessing health and disability across physical diseases and mental health disorders in both clinical and non-clinical settings and populations. Items are scored on a 5-point scale ranging from 0 (no difficulty) to 4 (extreme difficulty/cannot do) and are summed to create total (ranging from 0 to 144) and domain scores: cognition (ranging from 0 to 28); mobility (ranging from 0 to 20); self-care (ranging from 0 to 16); getting along with people (ranging from 0 to 20); life activities (ranging from 0 to 32); and participating in society (ranging from 0 to 32). Higher scores for each domain indicate greater disability. Psychometric properties are excellent, with high internal consistency, test-retest reliability, a stable factor structure, good concurrent validity, and good sensitivity to change.
Measured: Post-treatment (approximately 12 weeks post-randomization)
World Health Organization Quality of Life Scale (WHOQOL-BREF) - Post-Treatment
The World Health Organization Quality of Life Scale (WHOQOL-BREF) is a 26-item questionnaire assessing four domains of quality of life: physical health, psychological well-being, quality of social relationships, and environmental quality. Items use different anchors but are rated on a scale from 1 to 5. Mean scores are calculated for each domain and then transformed to range from 0 (poorest quality of life) to 100 (best quality of life). Psychometric properties of the WHOQOL-BREF are excellent, with demonstrated high internal consistency, discriminant validity, and construct validity for general, mental health, and physical health populations. The WHOQOL-BREF is used as part of the CBT-CP assessment protocol.
Measured: Post-treatment (approximately 12 weeks post-randomization)
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference (Follow-up)
The West Haven Yale Multidimensional Pain Inventory (WHYMPI) is a 52-item questionnaire providing a comprehensive assessment of components of the chronic pain experience that are helpful for the cognitive-behavioral conceptualization of chronic pain conditions. Each item is rated on a 7-point scale. The interference subscale will be used in this study and measures the impact of pain on functioning (household chores, outdoor work, recreation activities, social activities). An average score is calculated that ranges from 0 (no interference) to 6 (extreme interference). The WHYMPI has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The WHYMPI is used as part of the CBT-CP assessment protocol.
Measured: 3-Month Follow-up (approximately 24 weeks post-randomization)
Pain Severity (Pain Numeric Rating Scale, PNRS) - Follow-up
The Pain Numeric Rating Scale (PNRS) assesses pain severity over the past week based on a 0 (no pain) to 10 (worst pain imaginable) scale. Three items - average pain over the past week, worst pain over the past week, least pain over the past week - are averaged for an overall pain severity score. The PNRS has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The PNRS is used as part of the CBT-CP assessment protocol. Participants were assessed 3-months after completion of the study intervention, an expected average of 24 weeks post-randomization.
Measured: 3-Month Follow-up (approximately 24 weeks post-randomization)
Veterans RAND 36-item Health Survey (VR-36) (Follow-up)
The Veterans RAND 36-Item Health Survey (VR-36) is a 36-item questionnaire measuring health-related quality of life and 8 domains of health-related functioning (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health). Items are scored on a 3- to 6-point scale and are summed to create each of the domain scores, ranging from 0 (worst health status) to 100 (best health status). The VR-36 demonstrated improved reliability, precision, and validity compared to the SF-36 and among persons with SMI.
Measured: 3-Month Follow-up (approximately 24 weeks post-randomization)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - Follow-up
The WHODAS 2.0 is a 36-item questionnaire assessing health and disability across physical diseases and mental health disorders in both clinical and non-clinical settings and populations. Items are scored on a 5-point scale ranging from 0 (no difficulty) to 4 (extreme difficulty/cannot do) and are summed to create total (ranging from 0 to 144) and domain scores: cognition (ranging from 0 to 28); mobility (ranging from 0 to 20); self-care (ranging from 0 to 16); getting along with people (ranging from 0 to 20); life activities (ranging from 0 to 32); and participating in society (ranging from 0 to 32). Higher scores for each domain indicate greater disability. Psychometric properties are excellent, with high internal consistency, test-retest reliability, a stable factor structure, good concurrent validity, and good sensitivity to change.
Measured: 3-Month Follow-up (approximately 24 weeks post-randomization)
World Health Organization Quality of Life Scale (WHOQOL-BREF) - Follow-up
The World Health Organization Quality of Life Scale (WHOQOL-BREF) is a 26-item questionnaire assessing four domains of quality of life: physical health, psychological well-being, quality of social relationships, and environmental quality. Items use different anchors but are rated on a scale from 1 to 5. Mean scores are calculated for each domain and then transformed to range from 0 (poorest quality of life) to 100 (best quality of life). Psychometric properties of the WHOQOL-BREF are excellent, with demonstrated high internal consistency, discriminant validity, and construct validity for general, mental health, and physical health populations. The WHOQOL-BREF is used as part of the CBT-CP assessment protocol.
Measured: 3-Month Follow-up (approximately 24 weeks post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start18 Mar 2021
- Primary completion4 Jul 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and preliminarily evaluate participant responses to intervention. The first 45 Veterans who pass screening will be enrolled and randomized to study condition on a rolling basis. Participants will be randomly assigned at a 2:1 ratio to CBT-CP:Health \& Wellness using permuted block randomization with randomly varying block sizes. Veterans will be randomly assigned to either CBT-CP (n = 30) or a manualized Health \& Wellness active control intervention (n = 15). Using an intent-to-treat framework, data will be collected from every participant during the one-week Ecological Momentary Assessment period (prior to RCT baseline assessment) and at baseline, post-treatment, and 3-month follow-up regardless of attendance in their assigned condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Maryland Health Care System
- Responsible party
- Sponsor
- Investigators
- Letitia Travaglini, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118283
- Sponsor's protocol ID
- D3069-W
- Other IDs
- 1IK2RX003069-01A2
- Acronym
- CPSMI
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2019
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciesinski NK, Coakley GN, Nguyen RL, Loecher AK, Harvey KP, Travaglini LE. Affect, Coping, and Self-Harm Among Veterans With Comorbid Serious Mental Illness and Chronic Pain: A Pilot Study. Psychiatr Serv. 2026 Apr 1;77(4):316-324. doi: 10.1176/appi.ps.20250130. Epub 2026 Jan 15.
PubMed 41535739
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT04118283
- Acronym / sponsor ID
- CPSMI / D3069-W
- Conditions
- Chronic Pain, Schizophrenia, Psychotic Disorders, Bipolar Disorder, Affective Disorders, Psychotic
- Keywords
- Veterans, chronic pain, psychotic disorders, affective disorders, psychotic, cognitive behavioral therapy, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Maryland Health Care System
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.
Detailed description
This research study will address critical gaps in our understanding and management of chronic musculoskeletal pain in Veterans with serious mental illness (SMI), addressing the following aims:
Aim 1: Complete a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of CBT-CP and preliminarily evaluate participant responses to intervention.
Aim 1a (Primary): Determine feasibility by demonstrating adequate rates of recruitment and completion of and fidelity to the CBT-CP intervention as well as quality and acceptability of chosen assessments.
Aim 1b (Primary): Determine acceptability by obtaining favorable ratings from satisfaction questionnaires and interviews.
Aim 1c (Exploratory): Preliminarily evaluate participant responses to intervention by exploring changes in functioning and quality of life among Veterans randomized to the CBT-CP condition (n=30).
Aim 2: Determine the feasibility of collecting EMA data to examine the temporal relationships among mental health symptoms, pain severity, and health-related functioning. Data will be collected at baseline from the 45 Veterans in the Aim 1 RCT.
Aim 2b (Primary): Determine feasibility of this approach through adherence to the EMA call schedule and overall response rates.
Aim 2a (Exploratory): Explore relationships among mental health symptoms, pain severity, and health-related functioning captured in real time.
Aim 3: Complete a well-specified process evaluation to explore how to optimize CBT-CP for use in Veterans with SMI and chronic musculoskeletal pain in future clinical trials. This evaluation will integrate qualitative data from 15 interviews with Veterans in the CBT-CP condition, CBT-CP interventionist notes, and quantitative data from Aims 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study involves a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and preliminarily evaluate participant responses to intervention. The first 45 Veterans who pass screening will be enrolled and randomized to study condition on a rolling basis. Participants will be randomly assigned at a 2:1 ratio to CBT-CP:Health \& Wellness using permuted block randomization with randomly varying block sizes. Veterans will be randomly assigned to either CBT-CP (n = 30) or a manualized Health \& Wellness active control intervention (n = 15). Using an intent-to-treat framework, data will be collected from every participant during the one-week Ecological Momentary Assessment period (prior to RCT baseline assessment) and at baseline, post-treatment, and 3-month follow-up regardless of attendance in their assigned condition.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Chronic Pain | Experimental | Behavioral: Cognitive Behavioral Therapy for Chronic PainCognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan. |
| Health and Wellness | Active comparator | Behavioral: Health and WellnessHealth \& Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a chronic musculoskeletal pain diagnosis
- Have a Defense and Veterans Pain Rating Scale (DVPRS) rating of 4 or greater for pain severity
- Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder) per medical record
- 18 years of age or older
- Enrolled in outpatient programming within the VA Maryland Health Care System at time of consent/study reenrollment
Key exclusion criteria (3 listed)
- Are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by treating provider)
- Engagement in Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past
- Have a current acute pain condition or limited mobility (i.e., unable to walk one city block) that would interfere with their ability to engage in CBT-CP interventions (e.g., activity pacing/walking program)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Chronic PainAlso: CBT-CPCognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan. | Behavioural | Cognitive Behavioral Therapy for Chronic Pain |
| Health and WellnessAlso: H&WHealth \& Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area. | Behavioural | Health and Wellness |
Primary outcome
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Retention and Adherence
Time frame: Data will be gathered from each participant through intervention completion, an average of 11 weeks
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists. The table below shows outcomes for objective 2a: retention and adherence rates.
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Treatment Completion Rates
Time frame: Data will be gathered from each participant through intervention completion, an average of 11 weeks
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists. The table below shows outcomes for objective 2b: treatment completion rates.
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Mean Number of Sessions Completed
Time frame: Data will be gathered from each participant through intervention completion, an average of 11 weeks
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists. The table below shows outcomes for objective 2c: mean number of sessions attended
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Mean Number of Home Practices Completed
Time frame: Data will be gathered from each CBT-CP participant through intervention completion, an average of 11 weeks
To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists. The table below shows outcomes for objective 4: mean number of home practice assignments completed.
Participant Satisfaction Questionnaire (CSQ-8)
Time frame: Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11), with overall assessment also reported
Participants completed a treatment satisfaction survey at mid-treatment (~session 5) and post-treatment (~session 11) that included the Client Satisfaction Questionnaire-8. The CSQ-8 contains eight Likert scale items that ask about quality of service received and if services have been helpful. Average scores on the CSQ-8 range from 1 (lowest) to 4 (highest), with higher average scores indicating greater satisfaction. This measure was used to assess CBT-CP acceptability via treatment satisfaction surveys (Aim 1b). For analyses, post-treatment CSQ (week 11) was used for treatment completers; mid-point CSQ (week 5) was used for individuals who did not complete a full course of treatment.
Service Satisfaction Scale (SSS-18)
Time frame: Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11), with overall assessment also reported
Participants were invited to complete a treatment satisfaction survey at mid-treatment (~session/week 5) and post-treatment (~session/week 11) that included the Service Satisfaction Scale-18 (SSS-18).The SSS-18 has 18 items that assess practitioner manner and skill, perceived outcome, office procedures, and accessibility. An average score was calculated for each participant, ranging from 1 (lowest) to 5 (highest). This measure was used to assess CBT-CP acceptability along with the CSQ-8 (Aim 1b). For analyses, post-treatment SSS-18 (week 11) was used for treatment completers; mid-point SSS-18 (week 5) was used for individuals who did not complete a full course of treatment.
Ecological Momentary Assessment - Feasibility, Completed Surveys
Time frame: One week, between consent and baseline assessment
The Ecological Momentary Assessment (EMA) survey included 18 questions about pain severity, pain-related functioning (impact on stress, mood, sleep, activity; DVPRS), and SMI symptoms (depression [PHQ-2], mania [ISS-A], psychosis [BASIS-24]) experienced over the past hour. Pain-related items were derived from validated measures (Defense and Veterans Pain Rating Scale, pain severity and supplemental items) rated on a 0 (no pain/pain interference) to 10 (worst pain/complete interference); the sleep item was only asked once per day. Items from validated mental health symptom measures were used, but response scales were modified to yes/no format (i.e., whether person experienced the symptom in the past hour). Participants received three (3) surveys per day via text message (link to REDCap survey) for seven (7) days (21 total surveys); the first survey was delivered between 8am-12pm, the second between 12pm-4pm, and the third between 4pm-8pm.
10 secondary outcomes
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference (Post-Treatment)
Time frame: Post-treatment (approximately 12 weeks post-randomization)
Pain Severity (Pain Numeric Rating Scale, PNRS) - Post-Treatment
Time frame: Post-treatment (approximately 12 weeks post-randomization)
Veterans RAND 36-item Health Survey (VR-36) (Post-Treatment)
Time frame: Post-treatment (approximately 12 weeks post-randomization)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - Post-Treatment
Time frame: Post-treatment (approximately 12 weeks post-randomization)
World Health Organization Quality of Life Scale (WHOQOL-BREF) - Post-Treatment
Time frame: Post-treatment (approximately 12 weeks post-randomization)
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference (Follow-up)
Time frame: 3-Month Follow-up (approximately 24 weeks post-randomization)
Pain Severity (Pain Numeric Rating Scale, PNRS) - Follow-up
Time frame: 3-Month Follow-up (approximately 24 weeks post-randomization)
Veterans RAND 36-item Health Survey (VR-36) (Follow-up)
Time frame: 3-Month Follow-up (approximately 24 weeks post-randomization)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - Follow-up
Time frame: 3-Month Follow-up (approximately 24 weeks post-randomization)
World Health Organization Quality of Life Scale (WHOQOL-BREF) - Follow-up
Time frame: 3-Month Follow-up (approximately 24 weeks post-randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41535739Ciesinski NK, Coakley GN, Nguyen RL, Loecher AK, Harvey KP, Travaglini LE. Affect, Coping, and Self-Harm Among Veterans With Comorbid Serious Mental Illness and Chronic Pain: A Pilot Study. Psychiatr Serv. 2026 Apr 1;77(4):316-324. doi: 10.1176/appi.ps.20250130. Epub 2026 Jan 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Letitia Travaglini, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Chronic Pain and Health and Wellness in people with Chronic Pain and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility: Retention and Adherence (time frame: Data will be gathered from each participant through intervention completion, an average of 11 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.