N/A
N=47
Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Substance Use Disorders · Depression · Anxiety · Emotional Disorder · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT03315208 ↗Enrolled (actual)
47
Serious AEs
16.1%
Results posted
Apr 2021
Primary outcome: Primary: Acceptability of Adding UP Group Intervention to TAU — 28.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unified Protocol (UP) (Behavioral); Treatment as Usual (TAU) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Adding UP Group Intervention to TAU |
28.0 | — |
| PRIMARY Feasibility of Adding UP Group Intervention to TAU |
13; 6 | 0.63 |
| SECONDARY OASIS |
5.44; 6.82 | 0.29 |
| SECONDARY Depressive Symptoms Scale (ODSIS) |
6.06; 4.73 | .50 |
| SECONDARY Suicidal Ideation |
2.88; 1.09 | 0.45 |
| SECONDARY Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month |
1; 0 | — |
| SECONDARY Commitment to Sobriety |
16.88; 17.27 | 0.76 |
| SECONDARY Substance Craving |
12.88; 8.45 | .21 |
| SECONDARY Percentage of Past 30 Days Abstinent From Substances |
72.29; 68.89 | 0.77 |
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.
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
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03315208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.