Integrative Psychosocial Group Treatment
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|ClinicalTrials.gov Identifier: NCT03648177|
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Opioid Misuse||Behavioral: IPGT Behavioral: Treatment as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Integrated Psychosocial Group Treatment (IPGT): A Randomized Pilot Trial of a Harm Reduction and Preventative Approach for Patients With Chronic Pain at Risk for Opioid Misuse|
|Actual Study Start Date :||November 2, 2018|
|Actual Primary Completion Date :||February 28, 2019|
|Actual Study Completion Date :||February 28, 2019|
Active Comparator: Treatment as Usual
Active Comparator: (n=15) Treatment as Usual
The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain which allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic, non-pharmacologic approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Behavioral: Treatment as Usual
Experimental: IPGT (n=15) Integrated Psychosocial Group Treatment
IPGT consists of 6 weekly group sessions of motivational interviewing and behavioral change, self-management, and pain education focused on appropriate adherence to treatment and resisting urges to misuse prescription medications. The intervention also entails an education session on knowledge pertaining to overdose education and naloxone distribution. Topics covered in IPGT include: Pacing and goal setting, negative thinking, coping with stress and anxiety, sleep enhancement techniques, managing set-backs, and chronic pain and your life.
Behavioral Intervention for Patients with Chronic Pain
- Feasibility of attrition [ Time Frame: 12 Months ]Successful delivery of all intervention components to 75% of IPGT recipients.Treatment retention of 75% of IPGT recipients at the completion of the study will be analyzed by calculating number of recipients retained at 6 weeks divided by number of consented recipients.
- Acceptability [ Time Frame: 12 Months ]Acceptability will be determined with the Patient Satisfaction Questionnaire, a 16 item 5-point Likert scale. All items will be summed up in each subscale and divided by the total number of items to calculate composite scores. The median value of 3.0 will be used as a comparison to determine whether or not the experimental group mean composite scores differ from the hypothesized mean.
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): NCT03648177
|United States, Pennsylvania|
|UPMC Pain Medicine Program|
|Pittsburgh, Pennsylvania, United States, 15260|
|Principal Investigator:||Valerie Hruschak, PhD Candidate||University of Pittsburgh|