NCT03648177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

April 4, 2018

Last Update Submit

May 2, 2019

Conditions

Chronic PainOpioid Misuse

Keywords

Behavioral InterventionMedication AdherencePsychosocial Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability

    12 Months

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

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

IPGT

EXPERIMENTAL

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: IPGT

Interventions

IPGTBEHAVIORAL

Behavioral Intervention for Patients with Chronic Pain

IPGT
Treatment as UsualBEHAVIORAL

Standard Care

Treatment as Usual

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • non-English speaking
  • cannot attend group sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Pain Medicine Program

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • 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.

    PMID: 33576415DERIVED

MeSH Terms

Conditions

Chronic PainOpioid-Related DisordersMedication Adherence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Valerie Hruschak, PhD Candidate

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

April 4, 2018

First Posted

August 27, 2018

Study Start

November 2, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

US(1)