ARMS UP: Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
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 |
---|---|---|
|
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
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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
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.- 2017P001274
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
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)
|
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 |
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. |
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. |
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. |
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%
|
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. |
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. |
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
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 |
kbentley@mgh.harvard.edu |
- 2017P001274