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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03315208
Collaborator
(none)
56
1
2
21.9
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unified Protocol (UP)
  • Other: Treatment as Usual (TAU)
N/A

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

Study Type:
Interventional
Actual Enrollment :
56 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 :
Nov 22, 2017
Actual Primary Completion Date :
Sep 20, 2019
Actual Study Completion Date :
Sep 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of Adding UP Group Intervention to TAU [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 [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. OASIS [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) [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

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

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:

  8. Score at least in the moderate range on self-report anxiety questionnaire

  9. Score at least in the moderate range on self-report depression questionnaire

  10. Report of suicidal thoughts in the past week

  11. Report of engagement in non-suicidal self-injury in the past week

  12. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Addiction Recovery Management Service Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Eden Evins, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Kate Bentley, PhD, Assistant Professor, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03315208
Other Study ID Numbers:
  • 2017P001274
First Posted:
Oct 20, 2017
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kate Bentley, PhD, Assistant Professor, Harvard Medical School, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Participants were recruited from November 2017 to July 2019 from an outpatient treatment program for adolescents and young adults with substance use disorders.
Pre-assignment Detail Participants were randomized in cohorts of 5. Thus, participants underwent a "waiting to be randomized" period from enrollment until the date they were randomized. 9 participants were excluded between the point of enrollment to randomization; 8 due to not meeting inclusion criteria, and 1 withdrawn by the PI while waiting to be randomized.
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Period Title: Overall Study
STARTED 29 18
COMPLETED 16 12
NOT COMPLETED 13 6

Baseline Characteristics

Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone Total
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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. Total of all reporting groups
Overall Participants 29 18 47
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
29
100%
18
100%
47
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
21.6
(2.1)
21.6
(1.9)
21.6
(1.9)
Sex: Female, Male (Count of Participants)
Female
12
41.4%
8
44.4%
20
42.6%
Male
17
58.6%
10
55.6%
27
57.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
13.8%
1
5.6%
5
10.6%
Not Hispanic or Latino
25
86.2%
17
94.4%
42
89.4%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
2
6.9%
1
5.6%
3
6.4%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
2
6.9%
1
5.6%
3
6.4%
White
22
75.9%
13
72.2%
35
74.5%
More than one race
2
6.9%
3
16.7%
5
10.6%
Unknown or Not Reported
1
3.4%
0
0%
1
2.1%
ODSIS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
8.90
(5.18)
9.06
(4.84)
8.96
(5.00)
PHQ-9 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
12.69
(6.79)
12.89
(9.28)
12.77
(6.67)
GAD-7 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
10.52
(5.13)
9.28
(5.85)
10.04
(5.39)
OASIS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
9.03
(4.19)
9.11
(4.24)
9.06
(4.16)
BSS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
3.85
(6.11)
3.23
(5.41)
3.61
(5.80)
CSS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
15.24
(4.95)
16.72
(5.26)
15.81
(5.06)
Craving Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
17.48
(6.64)
14.83
(7.96)
16.47
(7.21)
Past 30-day PDA (percentage of days abstinent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of days abstinent]
51.84
(34.44)
61.30
(36.61)
55.46
(35.20)
Past-month NSSI (SITBI) (Count of Participants)
Count of Participants [Participants]
1
3.4%
2
11.1%
3
6.4%
Past-month SI (SITBI) (Count of Participants)
Count of Participants [Participants]
10
34.5%
5
27.8%
15
31.9%

Outcome Measures

1. Primary Outcome
Title Acceptability of Adding UP Group Intervention to TAU
Description 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.
Time Frame At the end of the 8-week treatment period

Outcome Measure Data

Analysis Population Description
13 participants who attended at least 1 Unified Protocol session completed the CSQ-8.
Arm/Group Title Unified Protocol + Treatment As Usual
Arm/Group 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. 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. 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.
Measure Participants 13
Mean (Standard Deviation) [units on a scale]
28.0
(4.6)
2. Primary Outcome
Title Feasibility of Adding UP Group Intervention to TAU
Description 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.
Time Frame 8-week treatment period

Outcome Measure Data

Analysis Population Description
Total numbers randomized to each condition
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 29 18
Count of Participants [Participants]
13
44.8%
6
33.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.63
Comments
Method Chi-squared, Corrected
Comments df=1
Method of Estimation Estimation Parameter Chi-squared statistic value
Estimated Value 0.23
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the OASIS at the post-treatment assessment (means at post-treatment reported below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [units on a scale]
5.44
(2.80)
6.82
(3.43)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.29
Comments p-value is for the model parameter of the condition-by-time interaction term.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value 0.72
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the post-treatment assessments (means reported below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [score on a scale]
6.06
(4.54)
4.73
(3.93)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .50
Comments p-value is for the model parameter of the condition-by-time interaction term.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -0.56
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the post-treatment assessment (means reported below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [score on a scale]
2.88
(4.56)
1.09
(2.47)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.45
Comments p-value is for the model parameter of the condition-by-time interaction term.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -1.96
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and >=1) for this analysis due to the non-normal distribution of this outcome.
6. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Count of Participants [Participants]
1
3.4%
0
0%
7. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the post-treatment assessment (means reported below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [score on a scale]
16.88
(5.55)
17.27
(6.90)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.76
Comments p-value is for the model parameter of the condition-by-time interaction term.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -0.19
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.
8. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the post-treatment assessment (means reported below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [score on a scale]
12.88
(7.03)
8.45
(6.01)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .21
Comments p-value is for the model parameter of the condition-by-time interaction term.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -1.07
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (< 15 and >= 15) for this analysis.
9. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Participants who completed the post-treatment assessment (means presented below).
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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.
Measure Participants 16 11
Mean (Standard Deviation) [percentage of past 30 days abstinent]
72.29
(28.77)
68.89
(21.41)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unified Protocol + Treatment As Usual, Treatment As Usual Alone
Comments Due to the non-normal distribution of the PDA variable, this variable was treated as binary (<50% and >=50%) for mixed models; however, due to the small numbers of participants (< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.77
Comments
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter t statistic
Estimated Value 0.29
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

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.
Adverse Event Reporting Description Adverse events were collected at the mid- and post-treatment assessments, which happened at 4 and 8 weeks, respectively, after the date of randomization, via systematic assessment. Non-systematic assessment was also used to collect information about adverse events by reviewing participants' electronic health records weekly during the study period.
Arm/Group Title Unified Protocol + Treatment As Usual Treatment As Usual Alone Not Randomized
Arm/Group 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. 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. 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. Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. 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. Participants in this arm were enrolled and completed the baseline visit but never randomized.
All Cause Mortality
Unified Protocol + Treatment As Usual Treatment As Usual Alone Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/29 (0%) 0/18 (0%) 0/9 (0%)
Serious Adverse Events
Unified Protocol + Treatment As Usual Treatment As Usual Alone Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/29 (10.3%) 4/18 (22.2%) 2/9 (22.2%)
General disorders
Pseudoseizure (resulting in emergency department visit) 0/29 (0%) 0 0/18 (0%) 0 1/9 (11.1%) 1
Psychiatric disorders
Relapse to substances (resulting in inpatient treatment) 2/29 (6.9%) 2 1/18 (5.6%) 1 0/9 (0%) 0
Relapse to substances (resulting in emergency department visit)) 0/29 (0%) 0 1/18 (5.6%) 2 0/9 (0%) 0
Active suicidal ideation with plan (resulting in inpatient treatment) 0/29 (0%) 0 1/18 (5.6%) 1 1/9 (11.1%) 1
Active suicidal ideation with plan (without inpatient treatment) 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Increase in psychotic symptoms (resulting in inpatient treatment) 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Other (Not Including Serious) Adverse Events
Unified Protocol + Treatment As Usual Treatment As Usual Alone Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 13/29 (44.8%) 8/18 (44.4%) 0/9 (0%)
General disorders
Adverse reaction to non-study medication 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Flu 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Headaches/migraine 1/29 (3.4%) 1 1/18 (5.6%) 1 0/9 (0%) 0
Weight gain 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Chest tightness attributed to onset of electronic cigarette use 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Head injury 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Asthma symptoms 0/29 (0%) 0 1/18 (5.6%) 2 0/9 (0%) 0
Abdominal pain/nausea/vomiting (in context of early withdrawal) 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Infections and infestations
Contracted STD 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Psychiatric disorders
Relapse to substances (without medical attention) 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Substance use resulting in emergency department visit (not hospitalized) 1/29 (3.4%) 2 0/18 (0%) 0 0/9 (0%) 0
Non-fatal overdose (without seeking medical attention) 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Entered intensive outpatient program for substance use 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Increased suicidal ideation or urges to engage in nonsuicidal self-injury 2/29 (6.9%) 2 3/18 (16.7%) 4 0/9 (0%) 0
Increased depressive symptoms 7/29 (24.1%) 7 3/18 (16.7%) 3 0/9 (0%) 0
Increased anxiety-related symptoms 2/29 (6.9%) 2 3/18 (16.7%) 3 0/9 (0%) 0
Cognitively impaired in context of increased anxiety/substance use (resulting in emergency departmen 1/29 (3.4%) 2 0/18 (0%) 0 0/9 (0%) 0
Increased manic symptoms 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Increased restlessness 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Increased binge eating 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Increased stress (related to study group participation) 1/29 (3.4%) 1 0/18 (0%) 0 0/9 (0%) 0
Increased stress (not study-related) 0/29 (0%) 0 1/18 (5.6%) 1 0/9 (0%) 0
Respiratory, thoracic and mediastinal disorders
Sleep apnea symptoms 0/29 (0%) 0 1/18 (5.6%) 2 0/9 (0%) 0

Limitations/Caveats

Due to dropout, there were small numbers of participants analyzed at post-treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Kate Bentley
Organization Massachusetts General Hospital/Harvard Medical School
Phone 617-724-7741
Email kbentley@mgh.harvard.edu
Responsible Party:
Kate Bentley, PhD, Assistant Professor, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03315208
Other Study ID Numbers:
  • 2017P001274
First Posted:
Oct 20, 2017
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021