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

NCT03315208 | Completed Results DMC

• 1 other identifier: 2017P001274
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Depression; Anxiety; Emotional Disorder; Suicidal Ideation; Suicidal and Self-injurious Behavior

Keywords

transdiagnostic treatment; cognitive-behavioral therapy; Unified Protocol; young adults; substance use disorder; emotional disorder; depression; anxiety; emotion dysregulation; self-injurious thoughts and behaviors

Outcome Measures

Primary Outcomes (2)

• Acceptability of Adding UP Group Intervention to TAU

  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.

  At the end of the 8-week treatment period

• Feasibility of Adding UP Group Intervention to TAU

  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.

  8-week treatment period

Secondary Outcomes (7)

• OASIS

  At the end of the 8-week treatment period

• Depressive Symptoms Scale (ODSIS)

  At the end of the 8-week treatment period

• Suicidal Ideation

  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

• Commitment to Sobriety

  At the end of the 8-week treatment period

Study Arms (2)

Unified Protocol + Treatment As Usual

EXPERIMENTAL

Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Behavioral: Unified Protocol (UP); Other: Treatment as Usual (TAU)

Treatment As Usual Alone

ACTIVE COMPARATOR

Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Other: Treatment as Usual (TAU)

Interventions

Unified Protocol (UP) BEHAVIORAL

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.

Unified Protocol + Treatment As Usual

Treatment as Usual (TAU) OTHER

Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Treatment As Usual Alone; Unified Protocol + Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Report of engagement in non-suicidal self-injury in the past week
• Not expected to require inpatient level of care within the next two weeks (as judged clinically)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Addiction Recovery Management Service

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders; Suicidal Ideation; Self-Injurious Behavior; Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Suicide

Limitations and Caveats

Due to dropout, there were small numbers of participants analyzed at post-treatment.

Results Point of Contact

• Title: Dr. Kate Bentley
• Organization: Massachusetts General Hospital/Harvard Medical School

kbentley@mgh.harvard.edu

617-724-7741

Study Officials

• Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 20, 2017
• Study Start: November 22, 2017
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)