Massachusetts General Hospital Addiction Recovery Management Service
Boston, Massachusetts, 02114, United States
NCT Number: NCT03315208
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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Notify Me18 year–26 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Only patients seeking services or currently engaged in care at the MGH Addiction Recovery Management Service are eligible for this study.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: At the end of the 8-week treatment period
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.
Time frame: 8-week treatment period
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.
Time frame: At the end of the 8-week treatment period
Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.
Time frame: At the end of the 8-week treatment period
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.
Time frame: At the end of the 8-week treatment period
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.
Time frame: At the end of the 8-week treatment period
Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.
Time frame: At the end of the 8-week treatment period
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.
Time frame: At the end of the 8-week treatment period
Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.
Time frame: At the end of the 8-week treatment period
Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.
Massachusetts General Hospital
Other
Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Acronym: ARMS UP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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