Anxiety, Depression, Emotional Disorder, Substance Use Disorders, Suicidal and Self-injurious Behavior, Suicidal Ideation
Conditions
Keywords
transdiagnostic treatment, cognitive-behavioral therapy, Unified Protocol, young adults, substance use disorder, emotional disorder, depression, anxiety, emotion dysregulation, self-injurious thoughts and behaviors
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.
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.
Interventions
BEHAVIORALUnified 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.
OTHERTreatment 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
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: 1. Score at least in the moderate range on self-report anxiety questionnaire 2. Score at least in the moderate range on self-report depression questionnaire 3. Report of suicidal thoughts in the past week 4. Report of engagement in non-suicidal self-injury in the past week 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 18 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 18 Participants | 47 Participants |
| Age, Continuous | 21.6 years STANDARD_DEVIATION 2.1 | 21.6 years STANDARD_DEVIATION 1.9 | 21.6 years STANDARD_DEVIATION 1.9 |
| BSS | 3.85 units on a scale STANDARD_DEVIATION 6.11 | 3.23 units on a scale STANDARD_DEVIATION 5.41 | 3.61 units on a scale STANDARD_DEVIATION 5.8 |
| Craving Scale | 17.48 units on a scale STANDARD_DEVIATION 6.64 | 14.83 units on a scale STANDARD_DEVIATION 7.96 | 16.47 units on a scale STANDARD_DEVIATION 7.21 |
| CSS | 15.24 units on a scale STANDARD_DEVIATION 4.95 | 16.72 units on a scale STANDARD_DEVIATION 5.26 | 15.81 units on a scale STANDARD_DEVIATION 5.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 17 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| GAD-7 | 10.52 units on a scale STANDARD_DEVIATION 5.13 | 9.28 units on a scale STANDARD_DEVIATION 5.85 | 10.04 units on a scale STANDARD_DEVIATION 5.39 |
| OASIS | 9.03 units on a scale STANDARD_DEVIATION 4.19 | 9.11 units on a scale STANDARD_DEVIATION 4.24 | 9.06 units on a scale STANDARD_DEVIATION 4.16 |
| ODSIS | 8.90 units on a scale STANDARD_DEVIATION 5.18 | 9.06 units on a scale STANDARD_DEVIATION 4.84 | 8.96 units on a scale STANDARD_DEVIATION 5 |
| Past 30-day PDA | 51.84 percentage of days abstinent STANDARD_DEVIATION 34.44 | 61.30 percentage of days abstinent STANDARD_DEVIATION 36.61 | 55.46 percentage of days abstinent STANDARD_DEVIATION 35.2 |
| Past-month NSSI (SITBI) | 1 Participants | 2 Participants | 3 Participants |
| Past-month SI (SITBI) | 10 Participants | 5 Participants | 15 Participants |
| PHQ-9 | 12.69 units on a scale STANDARD_DEVIATION 6.79 | 12.89 units on a scale STANDARD_DEVIATION 9.28 | 12.77 units on a scale STANDARD_DEVIATION 6.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 13 Participants | 35 Participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 18 | 0 / 9 |
| other Total, other adverse events | 13 / 29 | 8 / 18 | 0 / 9 |
| serious Total, serious adverse events | 3 / 29 | 4 / 18 | 2 / 9 |
Outcome results
Primary
Acceptability of Adding UP Group Intervention to TAU
Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received.
Time frame: At the end of the 8-week treatment period
Population: 13 participants who attended at least 1 Unified Protocol session completed the CSQ-8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Acceptability of Adding UP Group Intervention to TAU | 28.0 units on a scale | Standard Deviation 4.6 |
Primary
Feasibility of Adding UP Group Intervention to TAU
Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition.
Time frame: 8-week treatment period
Population: Total numbers randomized to each condition
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unified Protocol + Treatment As Usual | Feasibility of Adding UP Group Intervention to TAU | 13 Participants |
| Treatment As Usual Alone | Feasibility of Adding UP Group Intervention to TAU | 6 Participants |
p-value: 0.63Chi-squared, Corrected
Secondary
Commitment to Sobriety
Measured with the Commitment to Sobriety Scale (CSS) at post-treatment. Total scores range from 5-30; higher scores indicate higher levels of commitment to sobriety.
Time frame: At the end of the 8-week treatment period
Population: Participants who completed the post-treatment assessment (means reported below).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Commitment to Sobriety | 16.88 score on a scale | Standard Deviation 5.55 |
| Treatment As Usual Alone | Commitment to Sobriety | 17.27 score on a scale | Standard Deviation 6.9 |
Comparison: 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.p-value: 0.76Mixed Models Analysis
Secondary
Depressive Symptoms Scale (ODSIS)
Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of depressive symptoms.
Time frame: At the end of the 8-week treatment period
Population: Participants who completed the post-treatment assessments (means reported below).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Depressive Symptoms Scale (ODSIS) | 6.06 score on a scale | Standard Deviation 4.54 |
| Treatment As Usual Alone | Depressive Symptoms Scale (ODSIS) | 4.73 score on a scale | Standard Deviation 3.93 |
Comparison: 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.p-value: 0.5Mixed Models Analysis
Secondary
Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month
Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.
Time frame: At the end of the 8-week treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unified Protocol + Treatment As Usual | Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month | 1 Participants |
| Treatment As Usual Alone | Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month | 0 Participants |
Secondary
OASIS
Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | OASIS | 5.44 units on a scale | Standard Deviation 2.8 |
| Treatment As Usual Alone | OASIS | 6.82 units on a scale | Standard Deviation 3.43 |
Comparison: 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.p-value: 0.29Mixed Models Analysis
Secondary
Percentage of Past 30 Days Abstinent From Substances
Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.
Time frame: At the end of the 8-week treatment period
Population: Participants who completed the post-treatment assessment (means presented below).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Percentage of Past 30 Days Abstinent From Substances | 72.29 percentage of past 30 days abstinent | Standard Deviation 28.77 |
| Treatment As Usual Alone | Percentage of Past 30 Days Abstinent From Substances | 68.89 percentage of past 30 days abstinent | Standard Deviation 21.41 |
Comparison: 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).p-value: 0.77t-test, 2 sided
Secondary
Substance Craving
Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.
Time frame: At the end of the 8-week treatment period
Population: Participants who completed the post-treatment assessment (means reported below).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Substance Craving | 12.88 score on a scale | Standard Deviation 7.03 |
| Treatment As Usual Alone | Substance Craving | 8.45 score on a scale | Standard Deviation 6.01 |
Comparison: 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.p-value: 0.21Mixed Models Analysis
Secondary
Suicidal Ideation
Measured with the Beck Scale for Suicidal Ideation (BSI) at post-treatment. Total scores range from 0-38; higher scores indicate higher levels of suicidal ideation.
Time frame: At the end of the 8-week treatment period
Population: Participants who completed the post-treatment assessment (means reported below).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Suicidal Ideation | 2.88 score on a scale | Standard Deviation 4.56 |
| Treatment As Usual Alone | Suicidal Ideation | 1.09 score on a scale | Standard Deviation 2.47 |
Comparison: 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.p-value: 0.45Mixed Models Analysis