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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Unified Protocol (UP)
* Other: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol + Treatment As Usual<br>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)<br>* 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.<br>Other: Treatment as Usual (TAU)<br>* 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.<br>|
| Active Comparator: Treatment As Usual Alone<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transdiagnostic treatment, cognitive-behavioral therapy, Unified Protocol, young adults, substance use disorder, emotional disorder, depression, anxiety, emotion dysregulation, self-injurious thoughts and behaviors