Trial Outcomes & Findings for Cognitive-behavior Therapy for MS-Related Chronic Pain (NCT NCT00323271)

Last Updated: 2015-09-25

Results Overview

The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

baseline

Results posted on

2015-09-25

Participant Flow

Recruitment occured during April 2007 through September 2009. Participants were Veterans and nonVeterans recruited primarily through their providers in one of three treatment settings, namely the MS Clinics at the VA Connecticut Healthcare System and VA Boston Healthcare System and at the Yale MS Center.

1 subject enrolled into the study but was found to be ineligible before randomization.

Participant milestones

Participant milestones
Measure	Cognitive-behavior Therapy Behavioral: Cognitive-behavior therapy Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).	Educational Intervention Interventional: Educational intervention Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.
Overall Study STARTED	13	12
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive-behavior Therapy for MS-Related Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-behavior Therapy n=13 Participants Behavioral: Cognitive-behavior therapy Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).	Educational Intervention n=12 Participants Interventional: Educational intervention Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.	Total n=25 Participants Total of all reporting groups
Age, Continuous	53.23 Years STANDARD_DEVIATION 8.691 • n=5 Participants	54.67 Years STANDARD_DEVIATION 12.361 • n=7 Participants	53.95 Years STANDARD_DEVIATION 10.408 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Cognitive-behavior Therapy n=13 Participants Behavioral: Cognitive-behavior therapy Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).	Educational Intervention n=12 Participants Interventional: Educational intervention Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.
Pain Intensity	5.31 units on a scale Standard Deviation 2.213	5.42 units on a scale Standard Deviation 2.610

PRIMARY outcome

Timeframe: Baseline to Post Treatment (12 weeks)

Population: Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates

Outcome measures

Outcome measures
Measure	Cognitive-behavior Therapy n=13 Participants Behavioral: Cognitive-behavior therapy Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).	Educational Intervention n=12 Participants Interventional: Educational intervention Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.
Pain Intensity	5.76 units on a scale Standard Deviation 1.53	5.12 units on a scale Standard Deviation 2.51

Adverse Events

Cognitive-behavior Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Kerns, PhD

VA Connecticut Healthcare System

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place