Clinical trial NCT03315208: Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Official title: Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Acceptability of Adding UP Group Intervention to TAU
timeFrame: At the end of the 8-week treatment period
measure: Feasibility of Adding UP Group Intervention to TAU
timeFrame: 8-week treatment period
Secondary outcomes:
measure: OASIS
timeFrame: At the end of the 8-week treatment period
measure: Depressive Symptoms Scale (ODSIS)
timeFrame: At the end of the 8-week treatment period
measure: Suicidal Ideation
timeFrame: At the end of the 8-week treatment period
measure: Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month
timeFrame: At the end of the 8-week treatment period
measure: Commitment to Sobriety
timeFrame: At the end of the 8-week treatment period
measure: Substance Craving
timeFrame: At the end of the 8-week treatment period
measure: Percentage of Past 30 Days Abstinent From Substances
timeFrame: At the end of the 8-week treatment period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Addiction Recovery Management Service
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eden Evins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: