Clinical trial NCT03648177: Integrative Psychosocial Group Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Misuse
Keywords: Behavioral Intervention
Medication Adherence
Psychosocial Treatment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Staunton Farm Foundation
First posted: 2018-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A fundamental challenge for healthcare is to achieve a balance between decreasing the misuse of opioids and associated harms while optimizing patient care, including the provision of multidisciplinary treatments for chronic pain. However, despite recommendations that non-pharmacological interventions are rudimentary in the management of chronic pain, the literature describing which psychosocial interventions are best practice is nearly non-existent. Most of the psychosocial treatments that target either CNCP or opioid misuse are very general and broad-based therapies. However, there is a lack of evidence-informed direction guiding which psychosocial treatments should be adapted to this specialized population and thus, further research is needed.

Detailed description: This project is a pilot randomized controlled trial (RCT) of an Integrated Psychosocial Group Treatment (IPGT) in patients with chronic pain who are at risk for opioid misuse. IPGT is a comprehensive approach that blends evidenced-based psychosocial treatments for chronic pain and opioid misuse and addresses each issue individually, but also the interconnections between the overlapping problems. 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 and naloxone distribution. This study will involve the randomization of 40 patients to receive either: (1) treatment as usual (TAU; n=20); or (2) integrated psychosocial group intervention (IPGT; n=20). This study will: (1) establish feasibility; (2) demonstrate acceptability; and (3) demonstrate preliminary efficacy for an integrated psychosocial group treatment model for patients with chronic pain who are at risk of opioid misuse. The data generated from this study will also serve as a foundation for future implementation to support a subsequent fully-powered RCT.

Eligibility criteria: Inclusion Criteria:

* adults (≥18 years)
* chronic pain (3 months or longer)
* at risk for opioid misuse

Exclusion Criteria:

* non-English speaking
* cannot attend group sessions

Primary outcomes:
measure: Feasibility of attrition
timeFrame: 12 Months
Secondary outcomes:
measure: Acceptability
timeFrame: 12 Months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Pain Medicine Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Valerie Hruschak, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hruschak V, Rosen D, Tierney M, Eack SM, Wasan AD, Cochran G. Integrated Psychosocial Group Treatment: A Randomized Pilot Trial of a Harm Reduction and Preventive Approach for Patients with Chronic Pain at Risk of Opioid Misuse. Pain Med. 2021 Sep 8;22(9):2007-2018. doi: 10.1093/pm/pnaa461.