NCT03315208: ARMS UP

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

Completed NA Results posted Last updated 1 April 2021

What this trial tests

NA trial testing Unified Protocol (UP) in Substance Use Disorders in 56 participants. Completed in 20 September 2019.

Timeline

22 November 2017

Primary endpoint
20 September 2019

20 September 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	22 November 2017
Primary completion	20 September 2019
Estimated completion	20 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Unified Protocol (UP)
• Treatment as Usual (TAU) — full drug profile →

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Emotional Disorder — all drugs for Emotional Disorder →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 26, any sex, with Substance Use Disorders or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of Adding UP Group Intervention to TAU Primary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	28.0	± 4.6

Feasibility of Adding UP Group Intervention to TAU Primary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	13
Treatment As Usual Alone	6

OASIS Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	5.44	± 2.80
Treatment As Usual Alone	6.82	± 3.43

Depressive Symptoms Scale (ODSIS) Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	6.06	± 4.54
Treatment As Usual Alone	4.73	± 3.93

Suicidal Ideation Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	2.88	± 4.56
Treatment As Usual Alone	1.09	± 2.47

Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month Secondary · At the end of the 8-week treatment period

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

Group	Value	95% CI
Unified Protocol + Treatment As Usual	1
Treatment As Usual Alone	0

Commitment to Sobriety Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	16.88	± 5.55
Treatment As Usual Alone	17.27	± 6.90

Substance Craving Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	12.88	± 7.03
Treatment As Usual Alone	8.45	± 6.01

Percentage of Past 30 Days Abstinent From Substances Secondary · 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.

Group	Value	95% CI
Unified Protocol + Treatment As Usual	72.29	± 28.77
Treatment As Usual Alone	68.89	± 21.41

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected during the active study period (baseline to post-treatment assessment). Because the "waiting be be randomized" period (between baseline and date of randomization) varied across participants, the total study period lasted between 2 and 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Unified Protocol + Treatment As Usual

Serious: 3/29 (10%)

Deaths: 0/29

Treatment As Usual Alone

Serious: 4/18 (22%)

Deaths: 0/18

Not Randomized

Serious: 2/9 (22%)

Deaths: 0/9

Serious adverse events (6 terms)

Reaction	System	Unified Protocol + Treatme…	Treatment As Usual Alone	Not Randomized
Relapse to substances (resulting in inpatient treatment)	Psychiatric disorders	—	—	—
Relapse to substances (resulting in emergency department visit))	Psychiatric disorders	—	—	—
Active suicidal ideation with plan (resulting in inpatient treatment)	Psychiatric disorders	—	—	—
Active suicidal ideation with plan (without inpatient treatment)	Psychiatric disorders	—	—	—
Increase in psychotic symptoms (resulting in inpatient treatment)	Psychiatric disorders	—	—	—
Pseudoseizure (resulting in emergency department visit)	General disorders	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	Unified Protocol + Treatme…	Treatment As Usual Alone	Not Randomized
Increased depressive symptoms	Psychiatric disorders	—	—	—
Increased suicidal ideation or urges to engage in nonsuicidal self-injury	Psychiatric disorders	—	—	—
Increased anxiety-related symptoms	Psychiatric disorders	—	—	—
Relapse to substances (without medical attention)	Psychiatric disorders	—	—	—
Substance use resulting in emergency department visit (not hospitalized)	Psychiatric disorders	—	—	—
Non-fatal overdose (without seeking medical attention)	Psychiatric disorders	—	—	—
Entered intensive outpatient program for substance use	Psychiatric disorders	—	—	—
Cognitively impaired in context of increased anxiety/substance use (resulting in emergency departmen	Psychiatric disorders	—	—	—
Increased manic symptoms	Psychiatric disorders	—	—	—
Increased restlessness	Psychiatric disorders	—	—	—
Increased binge eating	Psychiatric disorders	—	—	—
Increased stress (related to study group participation)	Psychiatric disorders	—	—	—
Increased stress (not study-related)	Psychiatric disorders	—	—	—
Adverse reaction to non-study medication	General disorders	—	—	—
Flu	General disorders	—	—	—
Headaches/migraine	General disorders	—	—	—
Weight gain	General disorders	—	—	—
Chest tightness attributed to onset of electronic cigarette use	General disorders	—	—	—
Head injury	General disorders	—	—	—
Contracted STD	Infections and infestations	—	—	—
Sleep apnea symptoms	Respiratory, thoracic and mediastinal disorders	—	—	—
Asthma symptoms	General disorders	—	—	—
Abdominal pain/nausea/vomiting (in context of early withdrawal)	General disorders	—	—	—

Most-reported serious reactions: Relapse to substances (resulting in inpatient treatment), Relapse to substances (resulting in emergency department visit)), Active suicidal ideation with plan (resulting in inpatient treatment), Active suicidal ideation with plan (without inpatient treatment), Increase in psychotic symptoms (resulting in inpatient treatment), Pseudoseizure (resulting in emergency department visit).

Data from ClinicalTrials.gov NCT03315208 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.