Relationships between chronic pain and mood symptoms among veterans with bipolar disorder.
Letitia E Travaglini, Lorrianne Kuykendall, Melanie E Bennett...
https://pubmed.ncbi.nlm.nih.gov/33065815/Actively Recruiting
Led by VA Office of Research and Development · Updated on 2026-02-09
190
Participants Needed
1
Research Sites
N/A
Total Duration
Chronic musculoskeletal pain greatly impacts Veterans, especially those with serious mental illness SMI, leading to poorer mental and physical health and hindering recovery. Despite high rates of chronic pain in this group, there is limited research on non-drug pain management strategies. This research evaluates Cognitive Behavioral Therapy for Chronic Pain CBT-CP, an evidence-based psychotherapy, to understand its effects on pain-related functioning, quality of life, and pain severity in Veterans with SMI and chronic low back pain. Participants will be randomly assigned to either the CBT-CP program or an active control group called Health & Wellness H&W. CBT-CP involves 12 weekly individual sessions including pain education, goal-setting, and skill-building, with a booster session one month after the last session. The H&W group will receive 10 weekly sessions focused on general physical and emotional wellbeing topics without pain management content. Each session lasts 60 minutes and is led by trained interventionists following a structured manual. Veterans will be assessed at the start, after treatment approximately 4 months, and at a 6-month follow-up about 10 months after starting using tools like the Brief Pain Inventory-Interference, Veterans RAND 36-Item Health Survey, and PEG-3 scale. Additionally, one-week ecological momentary assessments will track daily pain and functioning. Researchers will monitor changes in pain, mental health symptoms, physical activity, and treatment engagement throughout the study, which includes a total participation period of about 10 months.
CONDITIONS
CBT-CP for Veterans With SMI
L
Letitia Travaglini, PhD
M
Melanie E Bennett
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VA Office of Research and Development
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CBT‑CP (12‑session behavioral therapy) | Health & Wellness psychoeducation | Standard CBT‑CP in VA practice |
|---|---|---|---|
| What it is | A 12‑session manualized individual Cognitive Behavioral Therapy for Chronic Pain, including a booster session | A structured Health & Wellness psychoeducation program with 10 weekly individual sessions | Standard VA Cognitive Behavioral Therapy for Chronic Pain delivered via similar 10‑ to 12‑session model in clinical practice |
| Role in trial | Experimental treatment arm | Active comparator arm | Contextual standard care option in VA, not part of the randomized comparison |
| Primary use | To reduce pain interference and improve health‑related quality of life in Veterans with chronic pain and serious mental illness | To provide health and wellness education as a non‑pain‑focused behavioral intervention | To manage chronic pain through established cognitive behavioral techniques in routine VA clinical practice |
| How it is given or performed | One 60‑minute individual session per week over 12 sessions using a manualized curriculum | One 60‑minute individual psychoeducation session per week for 10 weeks using a manual | Typically delivered in individual sessions over 10 to 12 weeks following the VA CBT‑CP manual |
| Evidence status | Effectiveness is being evaluated in this trial; outcomes include pain interference and quality of life | Effects are being compared to CBT‑CP on the same outcomes; evidence pending trial results | VA CBT‑CP has shown improvements in pain interference, catastrophizing, depression, and quality of life in observational program evaluations |
| Important risks | Not established—trial ongoing | Not established—trial ongoing | Behavioral therapy showed no serious adverse events in program evaluations |
| Important limitations | Trial outcomes are not yet available | Comparator is non‑pain‑focused psychoeducation, not current standard CBT‑CP | Program data come from observational implementation rather than randomized comparison |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks
Participants receive weekly individual therapy sessions to manage chronic pain and improve mental health functioning. This includes either Cognitive Behavioral Therapy for Chronic Pain with 12 sessions including a booster session or Health & Wellness psychoeducation with 10 sessions.
Weekly visits for up to 12 weeks
Duration - Approximately 6 months
Participants are evaluated on pain, functioning, and quality of life after treatment ends and again six months later to assess the lasting effects of the therapy.
2 follow-up visits (post-treatment and 6 months post-treatment)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Letitia E Travaglini, Lorrianne Kuykendall, Melanie E Bennett...
https://pubmed.ncbi.nlm.nih.gov/33065815/Letitia E Travaglini, Melanie Bennett, Corinne N Kacmarek...
https://pubmed.ncbi.nlm.nih.gov/37667502/VA Office of Research and Development
Lead Sponsor