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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315208
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Depression Anxiety Emotional Disorder Suicidal Ideation Suicidal and Self-injurious Behavior Behavioral: Unified Protocol (UP) Other: Treatment as Usual (TAU) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

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.




Primary Outcome Measures :
  1. Acceptability of adding UP group intervention to TAU [ Time Frame: 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.

  2. Feasibility of adding UP group intervention to TAU [ 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.


Secondary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: 8-week treatment period ]
    Measured with the Overall Anxiety Severity and Impairment Scale (OASIS) at baseline, mid-treatment, and post-treatment.

  2. Depressive symptoms Scale (ODSIS) [ Time Frame: 8-week treatment period ]
    Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at baseline, mid-treatment, and post-treatment.

  3. Suicidal ideation [ Time Frame: 8-week treatment period ]
    Measured with the Beck Scale for Suicidal Ideation (BSI) at baseline, mid-treatment, and post-treatment.

  4. Nonsuicidal self-injury [ Time Frame: 8-week treatment period ]
    Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at baseline, mid-treatment, and post-treatment.

  5. Commitment to sobriety [ Time Frame: 8-week treatment period ]
    Measured with the Commitment to Sobriety Scale (CSS) at baseline, mid-treatment, and post-treatment.

  6. Substance craving [ Time Frame: 8-week treatment period ]
    Measured with a three-item craving scale at baseline, mid-treatment, and post-treatment.

  7. Substance use [ Time Frame: 8-week treatment period ]
    Measured with the Timeline Follow Back (TLFB) at baseline, mid-treatment, and post-treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315208


Contacts
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Contact: Kate Bentley, PhD 617-724-7741 kbentley@mgh.harvard.edu
Contact: Eden Evins, MD, MPH 617-643-4691

Locations
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United States, Massachusetts
Massachusetts General Hospital Addiction Recovery Management Service Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kate H Bentley, PhD    617-724-7741    kbentley@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Eden Evins, MD, MPH Massachusetts General Hospital

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Responsible Party: A. Eden Evins, Director, Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03315208    
Other Study ID Numbers: 2017P001274
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A. Eden Evins, Massachusetts General Hospital:
transdiagnostic treatment
cognitive-behavioral therapy
Unified Protocol
young adults
substance use disorder
emotional disorder
depression
anxiety
emotion dysregulation
self-injurious thoughts and behaviors
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Depression
Suicidal Ideation
Self-Injurious Behavior
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Chemically-Induced Disorders
Suicide