Integrative Psychosocial Group Treatment

NCT ID: NCT03648177

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-02
• Study Completion Date: 2019-02-28

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.

Conditions

Chronic Pain; Opioid Misuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Standard Care

IPGT

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.

Group Type: EXPERIMENTAL

IPGT

Intervention Type: BEHAVIORAL

Behavioral Intervention for Patients with Chronic Pain

Interventions

IPGT

Behavioral Intervention for Patients with Chronic Pain

Intervention Type: BEHAVIORAL

Treatment as Usual

Standard Care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Staunton Farm Foundation

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Valerie Hruschak

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerie Hruschak, PhD Candidate

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Pain Medicine Program

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33576415 (View on PubMed)

Other Identifiers

PRO18040067

Identifier Type: -

Identifier Source: org_study_id