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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Suicidal Ideation; Emotional Disorder; Substance Use Disorders; Suicidal and Self-injurious Behavior
• Intervention / Treatment: Behavioral: Unified Protocol (UP); Other: Treatment as Usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Addiction Recovery Management Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OASIS	Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.	At the end of the 8-week treatment period
Depressive Symptoms Scale (ODSIS)	Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of depressive symptoms.	At the end of the 8-week treatment period
Suicidal Ideation	Measured with the Beck Scale for Suicidal Ideation (BSI) at post-treatment. Total scores range from 0-38; higher scores indicate higher levels of suicidal ideation.	At the end of the 8-week treatment period
Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month	Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.	At the end of the 8-week treatment period
Commitment to Sobriety	Measured with the Commitment to Sobriety Scale (CSS) at post-treatment. Total scores range from 5-30; higher scores indicate higher levels of commitment to sobriety.	At the end of the 8-week treatment period
Substance Craving	Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.	At the end of the 8-week treatment period
Percentage of Past 30 Days Abstinent From Substances	Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.	At the end of the 8-week treatment period

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Eden Evins, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: depression; anxiety; young adults; Unified Protocol; emotion dysregulation; cognitive-behavioral therapy; transdiagnostic treatment; substance use disorder; emotional disorder; self-injurious thoughts and behaviors
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Suicide; Substance-Related Disorders; Depression; Disease; Suicidal Ideation; Self-Injurious Behavior
• Other Study ID Numbers: 2017P001274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No