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| ID | Type | Description | Link |
|---|---|---|---|
| IK2CX002286 | U.S. NIH Grant/Contract | View source |
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Severe chronic pain and opioid use disorder (OUD) occur at significantly higher rates in Veterans compared to the general population. Chronic pain often persists despite engagement in opioid agonist treatment (OAT), the first line treatment for OUD. Recent VA guidelines strongly recommend non-pharmacologic treatment for chronic pain, but individuals with OUD are frequently excluded from pain treatment studies. There is a need for evidence-based pain treatments that compliment OAT for Veterans with chronic pain and OUD. In this study, the investigators will determine feasibility and acceptability for a behaviorally focused pain treatment that includes pain education and a pedometer assisted adaptive walking program for Veterans receiving OAT for OUD. Potential treatment outcomes will be repeatedly assessed using a mobile device, and study-provided pedometers. By offering pain treatment within OAT clinical care, the investigators hope to decrease stigma and increase access for Veterans with chronic pain and OUD.
The proposed study will address the pain treatment knowledge gap in Veterans with opioid use disorder (OUD) by piloting a behaviorally-based walking pain treatment for Veterans with chronic pain and OUD. Steps to Change (S2C) is a pain-focused treatment comprised of brief weekly 30-45-minute treatment sessions held over four consecutive weeks within the a Veterans Health Administration opioid agonist treatment (OAT) clinic. To date, no study has evaluated a pedometer-assisted walking program in individuals with chronic pain and OUD engaged in OAT. Topics for S2C include biopsychosocial pain education, pacing activities, benefits of physical activity, and an adaptive walking program derived from Cognitive Behavioral Therapy for chronic pain (CBT-CP) modules. The control will be matched for treatment exposure and attention. Veterans in both conditions will be provided a pedometer to record daily step counts as an objective measure of physical activity. Importantly, pain is a dynamic process that is known to vary over time and context. Veterans in both conditions will complete ecological momentary assessment (EMA) surveys, where behavior is repeatedly sampled using a mobile device.
The study objectives align closely with the description of a Stage IB pilot trial. Stage IB research determines feasibility and pilot testing of an adaptation or refinement of an existing intervention. Walking is a core component of CBT-CP and physical activity has a strong evidence base as a pain treatment for individuals with chronic pain; however, a walking program for chronic pain has not been evaluated in Veterans with chronic pain and OUD receiving OAT. Aim 1 will determine feasibility of study procedures including randomization, retention, fidelity, and proposed study outcomes of S2C and control conditions. Evaluating the feasibility of treatment and best practices for how quickly Veterans can be screened, consented, and randomized to start treatment is a critical step to inform a larger Stage II efficacy trial. In addition, the investigators will evaluate treatment attendance and retention in both S2C and control conditions to determine feasibility as well as discrimination of conditions for fidelity. The investigators will also collect data on mobile phone ownership and compare EMA survey response rates between conditions to inform future efficacy studies. The investigators expect that treatment attendance, retention, and survey responses for S2C will be equal to or superior then control. Aim 2 will establish acceptability of S2C and health education control by assessing intervention credibility and satisfaction at post-treatment. The investigators expect that Veterans in both conditions will report treatment as credible and satisfying. Finally, Aim 3 will evaluate preliminary evidence for whether S2C, compared to control, reduces pain interference assessed via interference items on the PEG. Primary endpoint will be at post-treatment, but the investigators will also evaluate durability or sleeper effects on pain interference at 3- and 6-month follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steps 2 Change (S2C) | Experimental | 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. 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. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steps 2 Change (S2C) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Treatment retention measured as the number of attended sessions (0-4; higher number is better) | Up to 5 weeks |
| Acceptability | Credibility measured using the Credibility/Expectancy Questionnaire with separate scores for credibility and expectancy (3-27; higher number is better). | After the first session, on the same calendar day |
| Fidelity | Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-5; higher number is better). | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Pain 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) | 0-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | 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) | 3-month and 6-month follow up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Ross MacLean, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States |
De-identified data that underlies published reported results after deidentification (text, tables, figures, appendices).
9 months to 36 months after publication of primary findings.
Up to 36 months after publication of primary findings, de-identified data can only be used for research purposes with a priori hypotheses including secondary analyses and/or meta-analysis combined with other datasets. Proposals should be directed to robert.maclean@va.gov.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2025 |
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Recruitment strategies will week to minimize the amount of time between screening visit and treatment start date. After completing screening visit, Veterans will begin a 7 day baseline EMA run-in period leading up to the start of the treatment week. First treatment session will be scheduled 7 days after screening visit. The feasibility of these procedures will be evaluated in Aim 1. Veterans who provide pedometer and EMA survey data on at least 3 days during baseline EMA will be randomized. Veterans will be randomized to either S2C or control in a 1:1 ratio using permuted block randomization stratified by OAT type (1=buprenorphine, 2=methadone) and sex (1=male, 2=female). A variable block size of 2 and 4 will be used to maintain balanced assignment to condition.
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General terms will be used when recruiting potential participants and in the informed consent. Study title on informed consent and recruitment materials will be "Enhancing self-management skills for individuals with opioid use disorder." Study measures (both in clinic and EMA) will be described as collecting data on problems that Veterans with OUD commonly report (e.g., negative mood, pain, quality of life, stress, etc.) and may improve with increased engagement in treatment. All in person assessment for post-treatment, 3 month follow up, and 6 month follow up will be collected by a research staff member who is blind to study condition. Data from EMA surveys at each time point will be provided by study participant whom is already blinded.
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| Control | Behavioral | 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. |
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| FG001 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OAT type | Count of Participants | Participants |
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| Length of time on current OAT | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Treatment retention measured as the number of attended sessions (0-4; higher number is better) | Posted | Mean | Standard Deviation | number of sessions attended | Up to 5 weeks |
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| Primary | Acceptability | Credibility measured using the Credibility/Expectancy Questionnaire with separate scores for credibility and expectancy (3-27; higher number is better). | Credibility survey was not completed by 6 participants (3 in each group). | Posted | Mean | Standard Deviation | Score on a scale | After the first session, on the same calendar day |
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| Primary | Fidelity | Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-5; higher number is better). | We randomly selected 24 participants (12 in each arm) to evaluate fidelity using one of their session recordings. | Posted | Mean | Standard Deviation | Score on a scale | Up to 5 weeks |
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| Secondary | Pain Interference | Pain 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) | Posted | Mean | Standard Deviation | Units on a scale | 0-5 weeks |
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| Other Pre-specified | Pain Interference | 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) | Missing data from participants who did not complete follow up visits. | Posted | Mean | Standard Deviation | Score on a scale | 3-month and 6-month follow up |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Steps 2 Change (S2C) | 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. | 0 | 30 | 2 | 30 | 14 | 30 |
| EG001 | Control | 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. | 0 | 30 | 4 | 30 | 10 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment | Three day inpatient for psychological observation, participant self presented to PER for depression with +SI and plan to OD. |
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| Drug Overdose | Psychiatric disorders | Systematic Assessment | Overdose of non-prescription opioids. |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Admitted to MICU after presenting to ER with shortness of breath. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Report of increased pain |
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| Detox | Psychiatric disorders | Systematic Assessment | Presented to PER for drug or alcohol detox |
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| Physical accident | Investigations | Systematic Assessment | Presented to medical ER for evaluation |
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| Illness | Infections and infestations | Systematic Assessment | Presented to ER with symptoms of illness |
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| Vision problems | Eye disorders | Systematic Assessment | Presented to clinic with blurred vision |
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| Medication | Psychiatric disorders | Systematic Assessment | Presented to ER for medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Ross MacLean | VA Connecticut Healthcare System | 203-932-5711 | 17423 | robert.maclean@va.gov |
| Jan 12, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2024 | Apr 7, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Methadone |
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| OG001 | 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. 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. |
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