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OpenTrials
Completed

NCT Number: NCT03648177

Integrative Psychosocial Group Treatment

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.

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Key information

Conditions

Chronic Pain Behavior Chemically-Induced Disorders Health Behavior Medication Adherence Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Misuse Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Pain Medicine Program

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPGT

Behavioral

Behavioral Intervention for Patients with Chronic Pain

Treatment as Usual

Behavioral

Standard Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Staunton Farm Foundation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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