Integrative Psychosocial Group Treatment

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648177
• Other study ID #: PRO18040067
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Misuse

Intervention

Behavioral:
• IPGT
Behavioral Intervention for Patients with Chronic Pain
• Treatment as Usual
Standard Care

Locations

Country	Name	City	State
United States	UPMC Pain Medicine Program	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Staunton Farm Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of attrition	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.	12 Months
Secondary	Acceptability	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.	12 Months