Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051644
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2021-09-10
Brief Title:
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 065 to 09055 Importantly multiple studies have demonstrated that repeatedly asking about pain eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IK2CX002286 | NIH | None | httpsreporternihgovquickSearchIK2CX002286 |