NCT03490981

Brief Cognitive Behavioral Therapy for Chronic Pain

Completed NA Results posted Last updated 3 March 2021

What this trial tests

NA trial testing Treatment as usual (TAU) in Chronic Pain in 30 participants. Completed in 1 May 2020.

Timeline

1 October 2018

Primary endpoint
20 January 2020

1 May 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 October 2018
Primary completion	20 January 2020
Estimated completion	1 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Treatment as usual (TAU) — full drug profile →
• Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Musculoskeletal Pain — all drugs for Musculoskeletal Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 79, any sex, with Chronic Pain or Musculoskeletal Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up Primary · 12 weeks

The WHYMPI-I is a validated 9-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 6, with higher scores indicating higher pain-related interference.

Group	Value	95% CI
TAU Only	3.43	± .32
TAU Plus Brief CBT-CP	3.10	± .33

Patient Health Questionnaire-9 (PHQ-9) to Assess Change at Follow up Secondary · 12 weeks

This measure is a 9-item measure of depressive symptoms validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms.

Group	Value	95% CI
TAU Only	7.35	± .80
TAU Plus Brief CBT-CP	6.23	± .83

Generalized Anxiety Disorder-7 (GAD-7) to Assess Change at Follow up Secondary · 12 weeks

This measure is a 7-item measure of anxiety symptoms validated for use in primary care. Total scores range from 0 to 21, with higher scores indicating more anxiety symptoms.

Group	Value	95% CI
TAU Only	4.97	± .90
TAU Plus Brief CBT-CP	5.57	± .94

Pain Numeric Rating Scale (NRS) to Assess Change at Follow up Secondary · 12 weeks

This single-item question asks respondents to rate their average level of pain on an 11-point scale (0-10). Higher scores indicate worse pain.

Group	Value	95% CI
TAU Only	5.37	± .61
TAU Plus Brief CBT-CP	4.24	± .61

Pain Self-Efficacy Questionnaire (PSEQ) to Assess Change at Follow up Secondary · 12 weeks

This validated measure includes 10-items related to pain-related self-efficacy, such as accomplishing goals and becoming more active. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.

Group	Value	95% CI
TAU Only	37.50	± 2.02
TAU Plus Brief CBT-CP	39.54	± 2.10

Pain Catastrophizing Scale (PCS) to Assess Change at Follow up Secondary · 12 weeks

This validated 13-item measure assesses pain-related cognitions such as pain magnification and perceived helplessness. Total scores range from 0 to 52, with higher scores indicating higher levels of negative pain-related thoughts.

Group	Value	95% CI
TAU Only	23.1	± 2.6
TAU Plus Brief CBT-CP	18.8	± 2.7

World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Change at Follow up Secondary · 12 weeks

This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains (i.e., physical health, psychological, social relationship, and environment). A total summary score across domains ranges from 24 (minimum) to 120 (maximum), with higher scores indicating greater overall quality of life.

Group	Value	95% CI
TAU Only	92.1	± 3.34
TAU Plus Brief CBT-CP	92.9	± 3.50

Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess Change at Follow up Secondary · 12 weeks

This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities.

Group	Value	95% CI
TAU Only	27.76	± 1.14
TAU Plus Brief CBT-CP	26.80	± 1.11

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment as Usual (TAU) Only

Serious: 2/15 (13%)

Deaths: 0/15

Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

Serious: 0/15 (0%)

Deaths: 0/15

Serious adverse events (2 terms)

Reaction	System	Treatment as Usual (TAU) O…	Treatment as Usual (TAU) P…
Stroke symptoms	Vascular disorders	—	—
Back/leg pain	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Stroke symptoms, Back/leg pain.

Data from ClinicalTrials.gov NCT03490981 adverse events section.

Sponsor's own description

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is designed specifically for use in integrated care settings. The first objective of the proposed study is to conduct a pilot randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess feasibility (i.e., recruitment and retention of participants, appropriateness of measures, and assessment of fidelity of service delivery). This trial will also preliminarily assess treatment effectiveness by examining changes in pain-related physical interference, psychological distress, pain intensity, and other related outcomes. Thirty eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), post-treatment, and at 12-week follow-up. The second objective of this study will be to explore patient and provider perceptions of Brief CBT-CP to identify potential modifications that will improve its quality and overall feasibility of delivery in future work. Participants will include up to 12 staff members as well as up to 12 patients who were randomized to Brief CBT-CP. Participants will be interviewed by telephone about key components of the treatment. Participants will comment on protocol and procedures in terms of acceptability (the perception that a treatment is agreeable or that its specific components are satisfactory), appropriateness (the perceived fit or compatibility of the intervention for a given provider or consumer), and feasibility (the extent to which a new treatment can be successfully carried out or is suitable for everyday use). This intervention has clear implications for translation to clinical practice and for improving pain care quality by providing an evidence-based protocol. The potential direct benefit to Veterans includes offering a safe, accessible, non-pharmacological treatment for chronic pain early in the trajectory of care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient and provider perspectives of Brief Cognitive Behavioral Therapy for Chronic Pain: a qualitative analysis of a pilot randomized controlled trial.
   Conrad M, Kimber JM, Moskal D, Pietropaoli VA, et al · · 2026 · PMID 41981856 · DOI 10.1093/tbm/ibag011
2. Feasibility Outcomes from a Pilot Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Chronic Pain Among Military Veterans.
   Beehler G, Funderburk J, King P, Wade M, et al · · 2026 · PMID 41942795 · DOI 10.1007/s10880-026-10148-x