Stepped Care for Patients to Optimize Whole Recovery (SC-POWR)
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|ClinicalTrials.gov Identifier: NCT05155163|
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : August 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder Chronic Pain||Behavioral: SC-POWR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Stepped Care for Patients to Optimize Whole Recovery|
|Actual Study Start Date :||August 18, 2022|
|Estimated Primary Completion Date :||August 31, 2025|
|Estimated Study Completion Date :||August 31, 2026|
No Intervention: Treatment as Usual
Treatment as usual for opioid use disorder
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.
- Change in composite illicit opioid use and pain interference [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]Opioid use is measured by the Timeline Followback (TLFB) and confirmed by urine drug testing. The TLFB uses a calendar to measure opioid or other drug use over a desired time period; it is a self-reported measure of drug use. To confirm the self report, a urine test will be performed to detect the presence of opioids. Pain interference is measured using the Brief Pain Inventory (BPI), an 11-item scale which is a self report of pain from 0 (no pain) to 10 (worst pain). The composite outcome will take into account reductions in both illicit opioid use and pain interference.
- Change in alcohol use [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]Measured by the TLFB. The Timeline Followback for alcohol uses a calendar to record amount of alcohol consumed over a desired time period.
- Change in anxiety [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]Measured by the Generalized Anxiety Scale - 2 item (GAD2). Higher scores mean greater anxiety.
- Change in depression [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]Measured by the Patient Health Questionnaire-2 (PHQ-2). Higher scores on the PHQ-2 mean more symptoms of depression.
- Change in pain intensity [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]Measured by the Brief Pain Inventory (BPI), which is a measure of chronic pain. Higher scores mean greater levels of pain.
- Change in sleep [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.
- Change in stress [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]Measured by the Perceived Stress Scale, 10-item self- report scale. Higher scores indicate greater levels of stress.
- Retention in MOUD [ Time Frame: 48 weeks ]Time from baseline until patient misses10 consecutive days of MOUD (based on dosing information from electronic health record)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155163
|Contact: Declan Barry, PhDemail@example.com|
|Contact: Elizabeth Porter, MBAfirstname.lastname@example.org|
|United States, Connecticut|
|North Haven, Connecticut, United States, 06473|
|Contact: Kim DiMeola, MA 203-781-4600 email@example.com|
|Principal Investigator:||Declan Barry||Yale School of Medicine|