Trial Outcomes & Findings for Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans (NCT NCT04724694)

NCT ID: NCT04724694

Last Updated: 2026-01-28

Results Overview

This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

184 participants

Primary outcome timeframe

12-weeks

Results posted on

2026-01-28

Participant Flow

Participant milestones

Participant milestones
Measure
Brief CBT for Chronic Pain and Treatment as Usual
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Treatment as Usual Only
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Overall Study
STARTED
92
92
Overall Study
COMPLETED
71
84
Overall Study
NOT COMPLETED
21
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Brief CBT for Chronic Pain and Treatment as Usual
n=92 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Treatment as Usual Only
n=92 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Total
n=184 Participants
Total of all reporting groups
Age, Continuous
60.3 years
STANDARD_DEVIATION 13.4 • n=158 Participants
57.8 years
STANDARD_DEVIATION 13.2 • n=157 Participants
59.0 years
STANDARD_DEVIATION 13.3 • n=315 Participants
Sex: Female, Male
Female
15 Participants
n=158 Participants
13 Participants
n=157 Participants
28 Participants
n=315 Participants
Sex: Female, Male
Male
77 Participants
n=158 Participants
79 Participants
n=157 Participants
156 Participants
n=315 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Asian
1 Participants
n=158 Participants
0 Participants
n=157 Participants
1 Participants
n=315 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Black or African American
16 Participants
n=158 Participants
13 Participants
n=157 Participants
29 Participants
n=315 Participants
Race (NIH/OMB)
White
71 Participants
n=158 Participants
71 Participants
n=157 Participants
142 Participants
n=315 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=158 Participants
8 Participants
n=157 Participants
12 Participants
n=315 Participants
Brief Pain Inventory -- Interference subscale (BPI-I)
6.0 score on a measure
STANDARD_DEVIATION 1.5 • n=158 Participants
6.1 score on a measure
STANDARD_DEVIATION 1.4 • n=157 Participants
6.0 score on a measure
STANDARD_DEVIATION 1.5 • n=315 Participants
Brief Pain Inventory -- Pain Intensity subscale (BPI-P)
5.5 score on a measure
STANDARD_DEVIATION 1.5 • n=158 Participants
5.6 score on a measure
STANDARD_DEVIATION 1.4 • n=157 Participants
5.6 score on a measure
STANDARD_DEVIATION 1.5 • n=315 Participants
Patient Health Questionnaire -- 9 (PHQ-9)
8.0 score on a measure
STANDARD_DEVIATION 5.4 • n=158 Participants
9.1 score on a measure
STANDARD_DEVIATION 6.2 • n=157 Participants
8.5 score on a measure
STANDARD_DEVIATION 5.8 • n=315 Participants
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess physical quality of life
11.7 score on a measure
STANDARD_DEVIATION 2.5 • n=158 Participants
12.0 score on a measure
STANDARD_DEVIATION 2.9 • n=157 Participants
11.9 score on a measure
STANDARD_DEVIATION 2.7 • n=315 Participants
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess psychological health
14.8 score on measure
STANDARD_DEVIATION 2.5 • n=158 Participants
14.1 score on measure
STANDARD_DEVIATION 2.9 • n=157 Participants
14.5 score on measure
STANDARD_DEVIATION 2.8 • n=315 Participants
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess social quality of life
14.0 score on a measure
STANDARD_DEVIATION 2.7 • n=158 Participants
14.0 score on a measure
STANDARD_DEVIATION 3.3 • n=157 Participants
14.0 score on a measure
STANDARD_DEVIATION 3.0 • n=315 Participants
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess environmental quality of li
15.9 score on a measure
STANDARD_DEVIATION 2.2 • n=158 Participants
15.4 score on a measure
STANDARD_DEVIATION 2.4 • n=157 Participants
15.7 score on a measure
STANDARD_DEVIATION 2.4 • n=315 Participants
Ability to Participate in Social Roles and Activities - short form (APSRA)
27.0 Score on a measure
STANDARD_DEVIATION 6.1 • n=158 Participants
27.2 Score on a measure
STANDARD_DEVIATION 5.9 • n=157 Participants
27.1 Score on a measure
STANDARD_DEVIATION 6.0 • n=315 Participants

PRIMARY outcome

Timeframe: 12-weeks

This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess Change at 12 Week Follow-up
5.35 score on instrument
Standard Error .22
4.58 score on instrument
Standard Error .23

SECONDARY outcome

Timeframe: 12-weeks

This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess Change at 12 Week Follow-up
5.43 score on intstrument
Standard Error 0.17
5.01 score on intstrument
Standard Error 0.18

SECONDARY outcome

Timeframe: 12-weeks

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

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Patient Health Questionnaire -- 9 (PHQ-9) to Assess Change at 12 Week Follow-up
8.10 score on instrument
Standard Error 0.54
6.75 score on instrument
Standard Error 0.57

SECONDARY outcome

Timeframe: 12-weeks

This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health Change at 12 Week Follow up
12.10 score on measure
Standard Error 0.29
13.016 score on measure
Standard Error 0.31

SECONDARY outcome

Timeframe: 12-weeks

This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Change at 12 Week Follow up
13.85 score on a measure
Standard Error 0.30
15.16 score on a measure
Standard Error 0.31

SECONDARY outcome

Timeframe: 12-weeks

This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Change at 12 Week Follow up
13.85 score on a measure
Standard Error 0.30
14.54 score on a measure
Standard Error 0.37

SECONDARY outcome

Timeframe: 12-weeks

This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health Change at 12 Week Follow up
15.67 score on a measure
Standard Error 0.24
16.28 score on a measure
Standard Error 0.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Treatment as Usual Only
n=84 Participants
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Brief CBT for Chronic Pain and Treatment as Usual
n=71 Participants
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess Change at 12 Week Follow up
26.90 score on instrument
Standard Error 0.73
28.32 score on instrument
Standard Error 0.77

Adverse Events

Brief CBT for Chronic Pain and Treatment as Usual

Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths

Treatment as Usual Only

Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Brief CBT for Chronic Pain and Treatment as Usual
n=92 participants at risk
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Treatment as Usual Only
n=92 participants at risk
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Vascular disorders
Evaluation for CVA
1.1%
1/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Rib fracture
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Infections and infestations
Admitted for persistent cough and sore throat
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Nervous system disorders
Admitted for evaluation of syncope
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Gastrointestinal disorders
Admitted for abdominal pain
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up

Other adverse events

Other adverse events
Measure
Brief CBT for Chronic Pain and Treatment as Usual
n=92 participants at risk
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 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.
Treatment as Usual Only
n=92 participants at risk
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Respiratory, thoracic and mediastinal disorders
Shortness of breath
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Infections and infestations
Upper respiratory infection
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Injury, poisoning and procedural complications
Injuries due to assault
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Foot pain
1.1%
1/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Gastrointestinal disorders
Abdominal pain and cramping
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Infections and infestations
Tooth abscess
0.00%
0/92 • Enrollment to 12 week follow-up
2.2%
2/92 • Enrollment to 12 week follow-up
Infections and infestations
Cellulitus
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Infections and infestations
Pneumonia
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Shoulder pain
1.1%
1/92 • Enrollment to 12 week follow-up
2.2%
2/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Arm pain
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up
Metabolism and nutrition disorders
Elevated blood sugar
2.2%
2/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Infections and infestations
COVID-19
1.1%
1/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Low back pain
3.3%
3/92 • Enrollment to 12 week follow-up
0.00%
0/92 • Enrollment to 12 week follow-up
Musculoskeletal and connective tissue disorders
Ankle pain
0.00%
0/92 • Enrollment to 12 week follow-up
1.1%
1/92 • Enrollment to 12 week follow-up

Additional Information

Gregory Beehler, PhD, MA

VA Center for Integrated Healthcare

Phone: 716-862-7934

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place