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

Mass General Brigham

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03315208

2017P001274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Only patients seeking services or currently engaged in care at the MGH Addiction Recovery Management Service are eligible for this study.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Unified Protocol + Treatment As Usual

Experimental group

Description:

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.

Treatment:

Other: Treatment as Usual (TAU)

Behavioral: Unified Protocol (UP)

Treatment As Usual Alone

Active Comparator group

Description:

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

Treatment:

Other: Treatment as Usual (TAU)