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An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment

Primary Purpose

Opioid Use Disorder, Chronic Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Steps 2 Change (S2C)
Control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Chronic Pain, Opioid Use Disorder, opioid agonist treatment, medications for opioid use disorder, methadone, buprenorphine, walking, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet DSM5 criteria for OUD and receiving stable (i.e., unchanged in 2 weeks) dose of OAT (i.e., buprenorphine or methadone) in VACHS outpatient addiction clinic
  • Report high impact chronic pain (Grade 3) that is defined by experiencing pain that interferes with work and activity on most days or every day in the past 3 months
  • Self-reported ability to walk 1 block
  • Access to a mobile phone with active data plan

Exclusion Criteria:

  • Untreated major psychiatric disorders (e.g., bipolar disorder, psychotic disorder)
  • Current (i.e., past month) active suicidal ideation
  • Substance use disorder requiring inpatient detoxification
  • Currently engaged in CBT for chronic pain treatment
  • Planned surgical intervention for pain

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steps 2 Change (S2C)

Control

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

Retention
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
Acceptability
Credibility measured using the Credibility/Expectancy Questionnaire (0-9 or 0-100% depending on the item; higher number is better).
Fidelity
Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-7; higher number is better).

Secondary Outcome Measures

Pain interference
Pain interference measured using the weekly average of two 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; higher number is better)

Full Information

First Posted
September 10, 2021
Last Updated
March 8, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05051644
Brief Title
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Official Title
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 weekly 60-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 primary treatment outcome (i.e., pain interference) will be collected using EMA. The use of EMA offers considerable benefits relative to in-clinic measurement including significantly reducing recall bias and substantially improving reliability of measurement. For example, compared to a single rating, a composite of five daily pain ratings over 2 weeks increased reliability from 0.65 to 0.90.55 Importantly, multiple studies have demonstrated that repeatedly asking about pain (e.g., 3 to 12 prompts per day for 2 weeks) does not increase pain reactivity. 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. Since S2C is explicitly intended to increase daily step count, credibility of S2C will also be evaluated by expect greater increases (compared to control) in mean daily step count from baseline to post-treatment. Finally, Aim 3 will determine preliminary efficacy for whether S2C, compared to control, reduces pain interference assessed via EMA. Primary endpoint will be at post-treatment, but the investigators will also evaluate durability or sleeper effects on pain interference assessed via EMA at 3- and 6-month follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Chronic Pain
Keywords
Chronic Pain, Opioid Use Disorder, opioid agonist treatment, medications for opioid use disorder, methadone, buprenorphine, walking, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steps 2 Change (S2C)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Steps 2 Change (S2C)
Intervention Description
Participants assigned to S2C and health education control will be scheduled for 60-minute weekly group sessions held over four consecutive weeks in the outpatient OAT clinic. 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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention
Description
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
Time Frame
Up to 5 weeks
Title
Acceptability
Description
Credibility measured using the Credibility/Expectancy Questionnaire (0-9 or 0-100% depending on the item; higher number is better).
Time Frame
Up to 5 weeks
Title
Fidelity
Description
Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-7; higher number is better).
Time Frame
Up to 5 weeks
Secondary Outcome Measure Information:
Title
Pain interference
Description
Pain interference measured using the weekly average of two 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; higher number is better)
Time Frame
Up to 5 weeks
Other Pre-specified Outcome Measures:
Title
Pain interference
Description
Pain interference measured using the weekly average of two 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; higher number is better)
Time Frame
3-month and 6-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet DSM5 criteria for OUD and receiving stable (i.e., unchanged in 2 weeks) dose of OAT (i.e., buprenorphine or methadone) in VACHS outpatient addiction clinic Report high impact or bothersome chronic pain defined by experiencing pain on most days or every day in the past 3 months that limits general activity or enjoyment Self-reported ability to walk 1 block Access to a mobile phone with active data plan Exclusion Criteria: Untreated major psychiatric disorders (e.g., bipolar disorder, psychotic disorder) Current (i.e., past month) active suicidal ideation Substance use disorder requiring inpatient detoxification Currently engaged in CBT for chronic pain treatment Planned surgical intervention for pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R. Ross MacLean, PhD
Phone
(203) 932-5711
Ext
7423
Email
robert.maclean@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Ross MacLean, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Ross MacLean, PhD
Phone
203-932-5711
Ext
7423
Email
robert.maclean@va.gov
First Name & Middle Initial & Last Name & Degree
R. Ross MacLean, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data that underlies published reported results after deidentification (text, tables, figures, appendices).
IPD Sharing Time Frame
9 months to 36 months after publication of primary findings.
IPD Sharing Access Criteria
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.

Learn more about this trial

An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment

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