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Completed

NCT Number: NCT03315208

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

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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Key information

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Addiction Recovery Management Service

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Unified Protocol (UP)

Behavioral

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 (TAU)

Other

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 outcomes

  1. Acceptability of Adding UP Group Intervention to TAU

    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.

  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 outcomes

  1. OASIS

    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.

  2. Depressive Symptoms Scale (ODSIS)

    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.

  3. Suicidal Ideation

    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.

  4. Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month

    Time frame: At the end of the 8-week treatment period

    Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.

  5. Commitment to Sobriety

    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.

  6. Substance Craving

    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.

  7. Percentage of Past 30 Days Abstinent From Substances

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: ARMS UP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Apr 1, 2021

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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