Trial Outcomes & Findings for Managing Chronic Pain in Veterans With Substance Use Disorders (NCT NCT00982410)

Last Updated: 2015-07-13

Results Overview

The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

131 participants

Primary outcome timeframe

Baseline, 3-, 6-, & 12-months

Results posted on

2015-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Treatment Group (CBT) An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.	Educational Supportive Group A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle
3-month Follow-up Assessment STARTED	65	66
3-month Follow-up Assessment COMPLETED	56	53
3-month Follow-up Assessment NOT COMPLETED	9	13
6-month Follow-up Assessment STARTED	65	64
6-month Follow-up Assessment COMPLETED	59	53
6-month Follow-up Assessment NOT COMPLETED	6	11
12-month Follow-up Assessment STARTED	65	64
12-month Follow-up Assessment COMPLETED	56	55
12-month Follow-up Assessment NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Behavioral Treatment Group (CBT) An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.	Educational Supportive Group A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle
3-month Follow-up Assessment Could not reach to schedule	8	9
3-month Follow-up Assessment Scheduled, no-show	1	2
3-month Follow-up Assessment Withdrawal by Subject	0	2
6-month Follow-up Assessment Could not reach to schedule	5	7
6-month Follow-up Assessment participant no transportation	1	0
6-month Follow-up Assessment incarceration	0	2
6-month Follow-up Assessment patent surgery	0	1
6-month Follow-up Assessment scheduled, no-show	0	1
12-month Follow-up Assessment Death	0	2
12-month Follow-up Assessment could not reach to schedule	6	5
12-month Follow-up Assessment Withdrawal by Subject	0	1
12-month Follow-up Assessment incarceration	2	1
12-month Follow-up Assessment scheduled, no-show	1	0

Baseline Characteristics

Managing Chronic Pain in Veterans With Substance Use Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Treatment Group n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.	Educational Supportive Group n=66 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	64 Participants n=7 Participants	128 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	51.7 years STANDARD_DEVIATION 9.2 • n=5 Participants	51.3 years STANDARD_DEVIATION 10.1 • n=7 Participants	51.5 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Self-reported average pain level in the past week via NRS-1	7.15 units on a scale STANDARD_DEVIATION 1.61 • n=5 Participants	7.09 units on a scale STANDARD_DEVIATION 1.62 • n=7 Participants	7.14 units on a scale STANDARD_DEVIATION 1.62 • n=5 Participants
WHY-MPI: Pain Severity Score	4.31 units on a scale STANDARD_DEVIATION 0.97 • n=5 Participants	4.31 units on a scale STANDARD_DEVIATION 0.89 • n=7 Participants	4.31 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants
WHY-MPI General Activity	2.24 units on a scale STANDARD_DEVIATION 0.82 • n=5 Participants	2.04 units on a scale STANDARD_DEVIATION 0.89 • n=7 Participants	2.14 units on a scale STANDARD_DEVIATION 0.86 • n=5 Participants
CPSS: Self- efficacy for physical functioning (FSE score)	63.9 units on a scale STANDARD_DEVIATION 22.0 • n=5 Participants	60.6 units on a scale STANDARD_DEVIATION 21.9 • n=7 Participants	62.3 units on a scale STANDARD_DEVIATION 21.9 • n=5 Participants
CPSS: self-efficacy for pain management (PSE score)	50.2 units on a scale STANDARD_DEVIATION 22.1 • n=5 Participants	42.1 units on a scale STANDARD_DEVIATION 19.8 • n=7 Participants	46.3 units on a scale STANDARD_DEVIATION 21.3 • n=5 Participants
Alcohol abuse or alcohol dependence Abuse or Dependence	38 participants n=5 Participants	35 participants n=7 Participants	73 participants n=5 Participants
Alcohol abuse or alcohol dependence No Abuse; No Dependence	27 participants n=5 Participants	31 participants n=7 Participants	58 participants n=5 Participants
Drug abuse or drug dependence Any drug abuse or dependence	30 participants n=5 Participants	33 participants n=7 Participants	63 participants n=5 Participants
Drug abuse or drug dependence No Abuse; No dependence	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants
Prescription opioid misuse Ever misused Rx opioids	37 participants n=5 Participants	39 participants n=7 Participants	76 participants n=5 Participants
Prescription opioid misuse Never misused Rx opioids	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3-, 6-, & 12-months

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)	6.47 units on a scale Standard Error 0.18	5.82 units on a scale Standard Error 0.24

PRIMARY outcome

Timeframe: Baseline, 3-,6-, 12-month

The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)	2.00 units on a scale Standard Error 0.06	2.24 units on a scale Standard Error 0.08

PRIMARY outcome

Timeframe: Baseline, 3-, 6-, 12- months

#days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Alcohol Use	4.04 #Days used Standard Error 0.92	2.05 #Days used Standard Error 0.58

PRIMARY outcome

Timeframe: Baseline, 3-, 6-, 12- months

\# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Drug Use	6.85 #Days used Standard Error 1.75	6.82 #Days used Standard Error 1.72

PRIMARY outcome

Timeframe: Baseline, 3-,6-,12-months

Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Pain Tolerance	65.5 seconds Standard Error 3.8	70.2 seconds Standard Error 3.2

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 12- months

As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Self-efficacy of Pain Management	47.59 units on a scale Standard Error 2.40	57.9 units on a scale Standard Error 2.15

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 12- months

The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=64 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=65 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
Self-efficacy of Physical Functioning	61.57 units on a scale Standard Error 2.41	69.12 units on a scale Standard Error 2.01

SECONDARY outcome

Timeframe: Baseline, 3-, 6-, 12-months

Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=47 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=55 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)	6.47 units on a scale Standard Error 0.19	5.84 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, 3mo, 6mo, 12mo follow-up

The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.

Outcome measures

Outcome measures
Measure	Educational Supportive Group n=47 Participants A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle	Cognitive Behavioral Treatment Group (CBT) n=55 Participants An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.
As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)	1.95 units on a scale Standard Error 0.08	2.22 units on a scale Standard Error 0.08

Adverse Events

Cognitive Behavioral Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Supportive Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Behavioral Treatment Group n=65 participants at risk An intervention treatment group to manage pain and decrease substance use abuse/misuse Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.	Educational Supportive Group n=66 participants at risk A control condition providing social support and education about pain and/or drug use. Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle
General disorders Participant Death	0.00% 0/65 • 5 years	4.5% 3/66 • Number of events 3 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Ilgen

Ann Arbor Veteran Affairs

Phone: (734) 845-3646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place