Trial Outcomes & Findings for Brief Cognitive Behavioral Therapy for Chronic Pain (NCT NCT03490981)

NCT ID: NCT03490981

Last Updated: 2021-03-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-03-03

Participant Flow

Participant milestones

Measure	Treatment as Usual (TAU) Only Primary care treatment as usual TAU: Participants assigned to TAU 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.	Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Treatment as Usual (TAU) Only Primary care treatment as usual TAU: Participants assigned to TAU 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.	Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Brief Cognitive Behavioral Therapy for Chronic Pain

Baseline characteristics by cohort

Measure	Treatment as Usual (TAU) Only n=15 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) n=15 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	55.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	53.1 years STANDARD_DEVIATION 17.3 • n=7 Participants	54.1 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
West Haven-Yale Multidimensional Pain Inventory - Interference	3.2 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	4.0 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	3.6 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up	3.43 units on a scale Standard Error .32	3.10 units on a scale Standard Error .33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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 Follow up	7.35 score on a scale Standard Error .80	6.23 score on a scale Standard Error .83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Generalized Anxiety Disorder-7 (GAD-7) to Assess Change at Follow up	4.97 score on a scale Standard Error .90	5.57 score on a scale Standard Error .94

SECONDARY outcome

Timeframe: 12 weeks

Population: N=13 for TAU due to missing NRS data

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.

Outcome measures

Measure	TAU Only n=13 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Pain Numeric Rating Scale (NRS) to Assess Change at Follow up	5.37 score on a scale Standard Error .61	4.24 score on a scale Standard Error .61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Pain Self-Efficacy Questionnaire (PSEQ) to Assess Change at Follow up	37.50 score on a scale Standard Error 2.02	39.54 score on a scale Standard Error 2.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Pain Catastrophizing Scale (PCS) to Assess Change at Follow up	23.1 score on a scale Standard Error 2.6	18.8 score on a scale Standard Error 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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 Change at Follow up	92.1 score on a scale Standard Error 3.34	92.9 score on a scale Standard Error 3.50

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

Measure	TAU Only n=14 Participants Primary care treatment as usual TAU: Participants assigned to TAU 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.	TAU Plus Brief CBT-CP n=13 Participants Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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 Follow up	27.76 score on a scale Standard Error 1.14	26.80 score on a scale Standard Error 1.11

Adverse Events

Treatment as Usual (TAU) Only

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment as Usual (TAU) Only n=15 participants at risk Primary care treatment as usual TAU: Participants assigned to TAU 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.	Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) n=15 participants at risk Primary care treatment as usual and Brief CBT-CP Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. 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.
Vascular disorders Stroke symptoms	6.7% 1/15 • Number of events 1 • 12 weeks	0.00% 0/15 • 12 weeks
Musculoskeletal and connective tissue disorders Back/leg pain	6.7% 1/15 • Number of events 1 • 12 weeks	0.00% 0/15 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gregory P. Beehler, Associate Director of Research

VA Center for Integrated Healthcare

Phone: 716-862-7934

Email: gregory.beehler@va.gov

Results disclosure agreements

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