Chronic Pain, Opioid Use Disorder
Conditions
Keywords
Chronic Pain, Opioid Use Disorder, opioid agonist treatment, medications for opioid use disorder, methadone, buprenorphine, walking, exercise
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 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.
Interventions
BEHAVIORALSteps 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.
BEHAVIORALControl
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | Up to 5 weeks | Treatment retention measured as the number of attended sessions (0-4; higher number is better) |
| Acceptability | After the first session, on the same calendar day | Credibility measured using the Credibility/Expectancy Questionnaire with separate scores for credibility and expectancy (3-27; higher number is better). |
| Fidelity | Up to 5 weeks | Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-5; higher number is better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | 0-5 weeks | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORR. Ross MacLean, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 11.4 |
| Length of time on current OAT | 5.2 years STANDARD_DEVIATION 4.1 |
| OAT type Buprenorphine | 19 Participants |
| OAT type Methadone | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 14 / 30 | 10 / 30 |
| serious Total, serious adverse events | 2 / 30 | 4 / 30 |
Outcome results
None listed