Trial Outcomes & Findings for Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders (NCT NCT03315208)

Last Updated: 2021-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

At the end of the 8-week treatment period

Results posted on

2021-04-01

Participant Flow

Participants were recruited from November 2017 to July 2019 from an outpatient treatment program for adolescents and young adults with substance use disorders.

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were excluded between the point of enrollment to randomization; 8 due to not meeting inclusion criteria, and 1 withdrawn by the PI while waiting to be randomized.

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	29	18
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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. 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.
Overall Study Lost to Follow-up	11	6
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unified Protocol + Treatment As Usual n=29 Participants 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.	Treatment As Usual Alone n=18 Participants 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 n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	18 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21.6 years STANDARD_DEVIATION 2.1 • n=5 Participants	21.6 years STANDARD_DEVIATION 1.9 • n=7 Participants	21.6 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
ODSIS	8.90 units on a scale STANDARD_DEVIATION 5.18 • n=5 Participants	9.06 units on a scale STANDARD_DEVIATION 4.84 • n=7 Participants	8.96 units on a scale STANDARD_DEVIATION 5.00 • n=5 Participants
PHQ-9	12.69 units on a scale STANDARD_DEVIATION 6.79 • n=5 Participants	12.89 units on a scale STANDARD_DEVIATION 9.28 • n=7 Participants	12.77 units on a scale STANDARD_DEVIATION 6.67 • n=5 Participants
GAD-7	10.52 units on a scale STANDARD_DEVIATION 5.13 • n=5 Participants	9.28 units on a scale STANDARD_DEVIATION 5.85 • n=7 Participants	10.04 units on a scale STANDARD_DEVIATION 5.39 • n=5 Participants
OASIS	9.03 units on a scale STANDARD_DEVIATION 4.19 • n=5 Participants	9.11 units on a scale STANDARD_DEVIATION 4.24 • n=7 Participants	9.06 units on a scale STANDARD_DEVIATION 4.16 • n=5 Participants
BSS	3.85 units on a scale STANDARD_DEVIATION 6.11 • n=5 Participants	3.23 units on a scale STANDARD_DEVIATION 5.41 • n=7 Participants	3.61 units on a scale STANDARD_DEVIATION 5.80 • n=5 Participants
CSS	15.24 units on a scale STANDARD_DEVIATION 4.95 • n=5 Participants	16.72 units on a scale STANDARD_DEVIATION 5.26 • n=7 Participants	15.81 units on a scale STANDARD_DEVIATION 5.06 • n=5 Participants
Craving Scale	17.48 units on a scale STANDARD_DEVIATION 6.64 • n=5 Participants	14.83 units on a scale STANDARD_DEVIATION 7.96 • n=7 Participants	16.47 units on a scale STANDARD_DEVIATION 7.21 • n=5 Participants
Past 30-day PDA	51.84 percentage of days abstinent STANDARD_DEVIATION 34.44 • n=5 Participants	61.30 percentage of days abstinent STANDARD_DEVIATION 36.61 • n=7 Participants	55.46 percentage of days abstinent STANDARD_DEVIATION 35.20 • n=5 Participants
Past-month NSSI (SITBI)	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Past-month SI (SITBI)	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the 8-week treatment period

Population: 13 participants who attended at least 1 Unified Protocol session completed the CSQ-8.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=13 Participants 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.	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. 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.
Acceptability of Adding UP Group Intervention to TAU	28.0 units on a scale Standard Deviation 4.6	—

PRIMARY outcome

Timeframe: 8-week treatment period

Population: Total numbers randomized to each condition

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.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=29 Participants 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.	Treatment As Usual Alone n=18 Participants 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.
Feasibility of Adding UP Group Intervention to TAU	13 Participants	6 Participants

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the OASIS at the post-treatment assessment (means at post-treatment reported below).

Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
OASIS	5.44 units on a scale Standard Deviation 2.80	6.82 units on a scale Standard Deviation 3.43

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the post-treatment assessments (means reported below).

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.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Depressive Symptoms Scale (ODSIS)	6.06 score on a scale Standard Deviation 4.54	4.73 score on a scale Standard Deviation 3.93

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the post-treatment assessment (means reported below).

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.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Suicidal Ideation	2.88 score on a scale Standard Deviation 4.56	1.09 score on a scale Standard Deviation 2.47

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

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

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the post-treatment assessment (means reported below).

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.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Commitment to Sobriety	16.88 score on a scale Standard Deviation 5.55	17.27 score on a scale Standard Deviation 6.90

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the post-treatment assessment (means reported below).

Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Substance Craving	12.88 score on a scale Standard Deviation 7.03	8.45 score on a scale Standard Deviation 6.01

SECONDARY outcome

Timeframe: At the end of the 8-week treatment period

Population: Participants who completed the post-treatment assessment (means presented below).

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

Outcome measures

Outcome measures
Measure	Unified Protocol + Treatment As Usual n=16 Participants 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.	Treatment As Usual Alone n=11 Participants 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.
Percentage of Past 30 Days Abstinent From Substances	72.29 percentage of past 30 days abstinent Standard Deviation 28.77	68.89 percentage of past 30 days abstinent Standard Deviation 21.41

Adverse Events

Unified Protocol + Treatment As Usual

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Treatment As Usual Alone

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Not Randomized

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Unified Protocol + Treatment As Usual n=29 participants at risk 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.	Treatment As Usual Alone n=18 participants at risk 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.	Not Randomized n=9 participants at risk Participants in this arm were enrolled and completed the baseline visit but never randomized.
Psychiatric disorders Relapse to substances (resulting in inpatient treatment)	6.9% 2/29 • Number of events 2 • 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 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.	5.6% 1/18 • Number of events 1 • 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 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.	0.00% 0/9 • 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 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.
Psychiatric disorders Relapse to substances (resulting in emergency department visit))	0.00% 0/29 • 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 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.	5.6% 1/18 • Number of events 2 • 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 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.	0.00% 0/9 • 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 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.
Psychiatric disorders Active suicidal ideation with plan (resulting in inpatient treatment)	0.00% 0/29 • 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 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.	5.6% 1/18 • Number of events 1 • 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 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.	11.1% 1/9 • Number of events 1 • 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 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.
Psychiatric disorders Active suicidal ideation with plan (without inpatient treatment)	3.4% 1/29 • Number of events 1 • 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 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.	0.00% 0/18 • 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 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.	0.00% 0/9 • 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 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.
Psychiatric disorders Increase in psychotic symptoms (resulting in inpatient treatment)	0.00% 0/29 • 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 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.	5.6% 1/18 • Number of events 1 • 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 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.	0.00% 0/9 • 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 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.
General disorders Pseudoseizure (resulting in emergency department visit)	0.00% 0/29 • 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 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.	0.00% 0/18 • 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 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.	11.1% 1/9 • Number of events 1 • 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 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.

Other adverse events

Additional Information

Dr. Kate Bentley

Massachusetts General Hospital/Harvard Medical School

Phone: 617-724-7741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place