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Clinical Trials/NCT03315208
NCT03315208
Completed
N/A

Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders

Massachusetts General Hospital1 site in 1 country56 target enrollmentNovember 22, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Massachusetts General Hospital
Enrollment
56
Locations
1
Primary Endpoint
Feasibility of Adding UP Group Intervention to TAU
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.

Detailed Description

Young adults with substance use disorder (SUD) commonly experience co-occurring emotional distress in the form of affective/emotional disorders (i.e. anxiety, depressive, and related disorders) and self-injurious thoughts and behaviors (SITBs). Based on the conceptualization of emotion dysregulation as a transdiagnostic treatment target, the current study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to target core psychopathological processes related to emotion dysregulation that underlie SITBs and emotional disorder pathology. Given its transdiagnostic format, the UP has the potential to address comorbidity among the emotional disorders (and other functionally similar problems such as SUDs) simultaneously and more comprehensively than single-diagnosis treatments. Patients seeking services or currently engaged in care at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders (the MGH Addiction Recovery Management Service) are eligible for this study. Participants will be randomized 2:1 to receive either UP + TAU or TAU alone. The adjunctive UP intervention consists of 16 twice-weekly group sessions (delivered over an 8-week period) designed to deliver transdiagnostic, emotion-focused CBT strategies.

Registry
clinicaltrials.gov
Start Date
November 22, 2017
End Date
September 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Bentley, PhD

Assistant Professor, Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Young adults ages 18 to 26, inclusive
  • English language proficiency
  • Ability to provide written, informed consent
  • Ability to attend in-person, outpatient sessions
  • Has provided consent to receive or is currently undergoing treatment at the MGH Addiction Recovery Management Service
  • Documented DSM-5 SUD diagnosis (limited to alcohol use disorder; cannabis use disorder; phencyclidine or other hallucinogen use disorder; inhalant use disorder, opioid use disorder; sedative, hypnotic, or anxiolytic use disorder; stimulant use disorder; other (or unknown) SUD)
  • Current elevated emotional distress, as evidenced by any one of the following:
  • Score at least in the moderate range on self-report anxiety questionnaire
  • Score at least in the moderate range on self-report depression questionnaire
  • Report of suicidal thoughts in the past week

Exclusion Criteria

  • Documented psychotic disorder (or current, clinically significant psychotic symptoms) that render the patient inappropriate for outpatient level of care or participation in group therapy (as judged clinically by study staff)
  • Current imminent suicide or homicide risk (as judged clinically by study staff)
  • Unwilling or unable to provide consent for study staff to access subject's medical records and coordinate care and exchange data with clinical staff at the Addiction Recovery Management Service
  • Unwilling or unable to identify an emergency contact

Outcomes

Primary Outcomes

Feasibility of Adding UP Group Intervention to TAU

Time Frame: 8-week treatment period

Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition.

Acceptability of Adding UP Group Intervention to TAU

Time Frame: At the end of the 8-week treatment period

Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received.

Secondary Outcomes

  • Depressive Symptoms Scale (ODSIS)(At the end of the 8-week treatment period)
  • Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month(At the end of the 8-week treatment period)
  • Suicidal Ideation(At the end of the 8-week treatment period)
  • Commitment to Sobriety(At the end of the 8-week treatment period)
  • OASIS(At the end of the 8-week treatment period)
  • Substance Craving(At the end of the 8-week treatment period)
  • Percentage of Past 30 Days Abstinent From Substances(At the end of the 8-week treatment period)

Study Sites (1)

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