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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2019-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unified Protocol + Treatment As Usual

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.

Group Type EXPERIMENTAL

Unified Protocol (UP)

Intervention Type 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.

Treatment as Usual (TAU)

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type 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.

Interventions

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Unified Protocol (UP)

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.

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Young adults ages 18 to 26, inclusive
2. English language proficiency
3. Ability to provide written, informed consent
4. Ability to attend in-person, outpatient sessions
5. Has provided consent to receive or is currently undergoing treatment at the MGH Addiction Recovery Management Service
6. 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)
7. Current elevated emotional distress, as evidenced by any one of the following:

1. Score at least in the moderate range on self-report anxiety questionnaire
2. Score at least in the moderate range on self-report depression questionnaire
3. Report of suicidal thoughts in the past week
4. Report of engagement in non-suicidal self-injury in the past week
8. Not expected to require inpatient level of care within the next two weeks (as judged clinically)

Exclusion Criteria

1. 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)
2. Current imminent suicide or homicide risk (as judged clinically by study staff)
3. 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
4. Unwilling or unable to identify an emergency contact

Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No