Substance Use DisordersARMS UPNCT03315208
Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
A study testing Unified Protocol (UP) and Treatment as Usual (TAU) in people with Substance Use Disorders and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Substance Use Disorders, Depression, Anxiety
- What is being tested?
- Unified Protocol (UP) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Addiction Recovery Management Service
Boston, Massachusetts, 02114
About this study
Official title: Pilot 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.
Read the 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.
- Conditions
- Substance Use Disorders, Depression, Anxiety, Emotional Disorder, Suicidal Ideation, Suicidal and Self-injurious Behavior
- Being tested
- Unified Protocol (UP), Treatment as Usual (TAU)
- Keywords
- transdiagnostic treatment, cognitive-behavioral therapy, Unified Protocol, young adults, substance use disorder, emotional disorder, depression, anxiety, emotion dysregulation, self-injurious thoughts and behaviors
- Medical subject headings
- Substance-Related Disorders, Depression, Anxiety Disorders, Suicidal Ideation, Self-Injurious Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol (UP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol + Treatment As Usual | Experimental | 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. Receives: Behavioral: Unified Protocol (UP); Other: Treatment as Usual (TAU) |
| Treatment As Usual Alone | Active comparator | Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8-week treatment period
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start22 Nov 2017
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Bentley, PhD, Massachusetts General Hospital
- Investigators
- Eden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315208
- Sponsor's protocol ID
- 2017P001274
- Acronym
- ARMS UP
- Status last verified
- Mar 2021
- First submitted
- 4 Oct 2017
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT03315208
- Acronym / sponsor ID
- ARMS UP / 2017P001274
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol + Treatment As Usual | Experimental | Behavioral: Unified Protocol (UP), Other: Treatment as Usual (TAU)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. |
| Treatment As Usual Alone | Active comparator | Other: Treatment as Usual (TAU)Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Unified Protocol + Treatment As Usual |
| 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. | Other | Treatment As Usual Alone, Unified Protocol + Treatment As Usual |
Primary outcome
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.
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.
7 secondary outcomes
OASIS
Time frame: At the end of the 8-week treatment period
Depressive Symptoms Scale (ODSIS)
Time frame: At the end of the 8-week treatment period
Suicidal Ideation
Time frame: At the end of the 8-week treatment period
Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month
Time frame: At the end of the 8-week treatment period
Commitment to Sobriety
Time frame: At the end of the 8-week treatment period
Substance Craving
Time frame: At the end of the 8-week treatment period
Percentage of Past 30 Days Abstinent From Substances
Time frame: At the end of the 8-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol (UP) and Treatment as Usual (TAU) in people with Substance Use Disorders and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Adding UP Group Intervention to TAU (time frame: At the end of the 8-week treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.