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

Primary Purpose

Substance Use Disorders, Depression, Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Unified Protocol (UP)

Treatment as Usual (TAU)

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring transdiagnostic treatment, cognitive-behavioral therapy, Unified Protocol, young adults, substance use disorder, emotional disorder, depression, anxiety, emotion dysregulation, self-injurious thoughts and behaviors

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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:
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
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

Sites / Locations

Massachusetts General Hospital Addiction Recovery Management Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unified Protocol + Treatment As Usual

Treatment As Usual Alone

Arm Description

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.

Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03315208

First Posted

October 4, 2017

Last Updated

March 5, 2021

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03315208

Brief Title

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

Acronym

ARMS UP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 22, 2017 (Actual)

Primary Completion Date

September 20, 2019 (Actual)

Study Completion Date

September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

transdiagnostic treatment, cognitive-behavioral therapy, Unified Protocol, young adults, substance use disorder, emotional disorder, depression, anxiety, emotion dysregulation, self-injurious thoughts and behaviors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Unified Protocol + Treatment As Usual

Arm Type

Experimental

Arm Description

Arm Title

Treatment As Usual Alone

Arm Type

Active Comparator

Arm Description

Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Intervention Type

Behavioral

Intervention Name(s)

Unified Protocol (UP)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Treatment as Usual (TAU)

Intervention Description

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 Measure Information:

Title

Acceptability of Adding UP Group Intervention to TAU

Description

Time Frame

At the end of the 8-week treatment period

Title

Feasibility of Adding UP Group Intervention to TAU

Description

Time Frame

8-week treatment period

Secondary Outcome Measure Information:

Title

OASIS

Description

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

Title

Depressive Symptoms Scale (ODSIS)

Description

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

Title

Suicidal Ideation

Description

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

Title

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

Description

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

Time Frame

At the end of the 8-week treatment period

Title

Commitment to Sobriety

Description

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

Title

Substance Craving

Description

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

Title

Percentage of Past 30 Days Abstinent From Substances

Description

Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.

Time Frame

At the end of the 8-week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eden Evins, MD, MPH

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital Addiction Recovery Management Service

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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