Trial Outcomes & Findings for An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment (NCT NCT05051644)
NCT ID: NCT05051644
Last Updated: 2026-02-04
Results Overview
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Up to 5 weeks
Results posted on
2026-02-04
Participant Flow
Veteran participants were recruited to the study in several ways, including: (1) hanging study flyers in outpatient clinics, (2) study staff attending clinic team meetings to provide information about the study and invite Veteran referrals to the study coordinator; (3) mailing opt-out letters allowing Veterans engaged in outpatient OAT to be contacted via phone call or state they do not wish to participate.
After consent and screening visit, participants began 7-days of baseline mobile surveys including three random and one end of day survey per day (4 total). To be randomized, Veterans will need to complete at least 3 end of day surveys with complete step and pain interference data. If a Veteran fails to complete surveys in first 2 days of baseline EMA week, research staff will contact Veteran to assess for technical difficulties and encourage survey completion.
Participant milestones
| Measure |
Steps 2 Change (S2C)
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets. The control will be matched for treatment exposure and individual attention.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Steps 2 Change (S2C)
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets. The control will be matched for treatment exposure and individual attention.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Baseline characteristics by cohort
| Measure |
Steps 2 Change (S2C)
n=30 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=30 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets. The control will be matched for treatment exposure and individual attention.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
54.4 years
STANDARD_DEVIATION 11.4 • n=1581 Participants
|
53.6 years
STANDARD_DEVIATION 11.3 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=41 Participants
|
27 Participants
n=1581 Participants
|
55 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=41 Participants
|
24 Participants
n=1581 Participants
|
43 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=41 Participants
|
30 Participants
n=1581 Participants
|
60 Participants
n=4626 Participants
|
|
OAT type
Buprenorphine
|
19 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
38 Participants
n=4626 Participants
|
|
OAT type
Methadone
|
11 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
|
Length of time on current OAT
|
6.0 years
STANDARD_DEVIATION 4.8 • n=41 Participants
|
5.2 years
STANDARD_DEVIATION 4.1 • n=1581 Participants
|
5.5 years
STANDARD_DEVIATION 4.4 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksTreatment retention measured as the number of attended sessions (0-4; higher number is better)
Outcome measures
| Measure |
Steps 2 Change (S2C)
n=30 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=30 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Retention
|
3.7 number of sessions attended
Standard Deviation 0.5
|
3.6 number of sessions attended
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: After the first session, on the same calendar dayPopulation: Credibility survey was not completed by 6 participants (3 in each group).
Credibility measured using the Credibility/Expectancy Questionnaire with separate scores for credibility and expectancy (3-27; higher number is better).
Outcome measures
| Measure |
Steps 2 Change (S2C)
n=27 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=27 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Acceptability
Expectancy
|
15.7 Score on a scale
Standard Deviation 4.8
|
15.9 Score on a scale
Standard Deviation 5.8
|
|
Acceptability
Credibility
|
18.7 Score on a scale
Standard Deviation 4.4
|
20.2 Score on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: We randomly selected 24 participants (12 in each arm) to evaluate fidelity using one of their session recordings.
Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-5; higher number is better).
Outcome measures
| Measure |
Steps 2 Change (S2C)
n=12 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=12 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Fidelity
|
3.1 Score on a scale
Standard Deviation 0.2
|
3.2 Score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 0-5 weeksPain interference measured using the average difference from baseline to post-treatment of two interference items on the PEG3: "What number best describes how pain is interfering with your life?" and "What number best describes how pain is interfering with your general activity?" (0-10; lower number is better)
Outcome measures
| Measure |
Steps 2 Change (S2C)
n=30 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=29 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Pain Interference
|
0.8 Units on a scale
Standard Deviation 2.1
|
0.9 Units on a scale
Standard Deviation 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-month and 6-month follow upPopulation: Missing data from participants who did not complete follow up visits.
Pain interference measured using the average difference from baseline to follow-up of two interference items on the PEG3: "What number best describes how pain is interfering with your life?" and "What number best describes how pain is interfering with your general activity?" (0-10; lower number is better)
Outcome measures
| Measure |
Steps 2 Change (S2C)
n=30 Participants
Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=29 Participants
Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Pain Interference
3-month
|
1.0 Score on a scale
Standard Deviation 2.2
|
0.9 Score on a scale
Standard Deviation 3.0
|
|
Pain Interference
6-month
|
1.2 Score on a scale
Standard Deviation 2.4
|
0.9 Score on a scale
Standard Deviation 2.8
|
Adverse Events
Steps 2 Change (S2C)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Steps 2 Change (S2C)
n=30 participants at risk
Participants randomized to S2C will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain related to cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
Steps 2 Change (S2C): Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain. Session 2 and 3 will introduce a progressive walking program with individual goals and weekly step count benchmarks and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting in Session 2. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=30 participants at risk
Participants randomized to control will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
Control: The control will be matched for treatment exposure and individual attention. Treatment discussion will explicitly avoid problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/30 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Psychiatric disorders
Drug Overdose
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
6.7%
2/30 • Number of events 2 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
Other adverse events
| Measure |
Steps 2 Change (S2C)
n=30 participants at risk
Participants randomized to S2C will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain related to cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
Steps 2 Change (S2C): Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain. Session 2 and 3 will introduce a progressive walking program with individual goals and weekly step count benchmarks and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting in Session 2. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
|
Control
n=30 participants at risk
Participants randomized to control will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
Control: The control will be matched for treatment exposure and individual attention. Treatment discussion will explicitly avoid problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.
|
|---|---|---|
|
Psychiatric disorders
Medication
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Investigations
Physical accident
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Infections and infestations
Illness
|
16.7%
5/30 • Number of events 8 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
16.7%
5/30 • Number of events 5 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Eye disorders
Vision problems
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
26.7%
8/30 • Number of events 11 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
20.0%
6/30 • Number of events 6 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
|
Psychiatric disorders
Detox
|
6.7%
2/30 • Number of events 3 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
3.3%
1/30 • Number of events 1 • Adverse events were recorded from screening through final follow up (i.e., 9-months).
The investigators used definitions consistent with clinicaltrials.gov. Possible adverse events were collected by study clinicians inquiring
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place