An interventional study of Unified Protocol (UP) and Treatment as Usual (TAU) in Substance Use Disorders, Depression and Anxiety, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 56 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Only patients seeking services or currently engaged in care at the MGH Addiction Recovery Management Service are eligible for this study.
Inclusion Criteria:
Current elevated emotional distress, as evidenced by any one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Other: Treatment as Usual (TAU)
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)
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 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
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
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
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
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
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
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
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
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
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
Participants were recruited from November 2017 to July 2019 from an outpatient treatment program for adolescents and young adults with substance use disorders.
| Milestone | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Started | 29 | 18 |
| Completed | 16 | 12 |
| Not completed | 13 | 6 |
| Withdrew: Lost to follow-up | 11 | 6 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| units on a scale | Unified Protocol + Treatment As Usual |
|---|---|
| Acceptability of Adding UP Group Intervention to TAU | 28.0 ± 4.6 |
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.
| Participants | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Feasibility of Adding UP Group Intervention to TAU | 13 | 6 |
Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.
| units on a scale | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| OASIS | 5.44 ± 2.80 | 6.82 ± 3.43 |
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.
| score on a scale | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Depressive Symptoms Scale (ODSIS) | 6.06 ± 4.54 | 4.73 ± 3.93 |
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.
| score on a scale | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Suicidal Ideation | 2.88 ± 4.56 | 1.09 ± 2.47 |
Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.
| Participants | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month | 1 | 0 |
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.
| score on a scale | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Commitment to Sobriety | 16.88 ± 5.55 | 17.27 ± 6.90 |
Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.
| score on a scale | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Substance Craving | 12.88 ± 7.03 | 8.45 ± 6.01 |
Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.
| percentage of past 30 days abstinent | Unified Protocol + Treatment As Usual | Treatment As Usual Alone |
|---|---|---|
| Percentage of Past 30 Days Abstinent From Substances | 72.29 ± 28.77 | 68.89 ± 21.41 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | 0/29 (0%) | 3/29 (10.3%) | 13/29 (44.8%) |
| Treatment As Usual Alone | 0/18 (0%) | 4/18 (22.2%) | 8/18 (44.4%) |
| Not Randomized | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) |
| Event | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Not Randomized |
|---|---|---|---|
| Active suicidal ideation with plan (resulting in inpatient treatment)Psychiatric disorders | 0/29 | 1/18 | 1/9 |
| Pseudoseizure (resulting in emergency department visit)General disorders | 0/29 | 0/18 | 1/9 |
| Relapse to substances (resulting in inpatient treatment)Psychiatric disorders | 2/29 | 1/18 | 0/9 |
| Relapse to substances (resulting in emergency department visit))Psychiatric disorders | 0/29 | 1/18 | 0/9 |
| Increase in psychotic symptoms (resulting in inpatient treatment)Psychiatric disorders | 0/29 | 1/18 | 0/9 |
| Active suicidal ideation with plan (without inpatient treatment)Psychiatric disorders | 1/29 | 0/18 | 0/9 |
| Event | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Not Randomized |
|---|---|---|---|
| Increased depressive symptomsPsychiatric disorders | 7/29 | 3/18 | 0/9 |
| Increased suicidal ideation or urges to engage in nonsuicidal self-injuryPsychiatric disorders | 2/29 | 3/18 | 0/9 |
| Increased anxiety-related symptomsPsychiatric disorders | 2/29 | 3/18 | 0/9 |
| Relapse to substances (without medical attention)Psychiatric disorders | 0/29 | 1/18 | 0/9 |
| Entered intensive outpatient program for substance usePsychiatric disorders | 0/29 | 1/18 | 0/9 |
| Increased binge eatingPsychiatric disorders | 0/29 | 1/18 | 0/9 |
| Increased stress (not study-related)Psychiatric disorders | 0/29 | 1/18 | 0/9 |
| Adverse reaction to non-study medicationGeneral disorders | 0/29 | 1/18 | 0/9 |
| Headaches/migraineGeneral disorders | 1/29 | 1/18 | 0/9 |
| Weight gainGeneral disorders | 0/29 | 1/18 | 0/9 |
| Age, Categorical(Participants) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 18 | 47 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Mean | 21.6 ± 2.1 | 21.6 ± 1.9 | 21.6 ± 1.9 |
| Sex: Female, Male(Participants) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Female | 12 | 8 | 20 |
| Male | 17 | 10 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 25 | 17 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 22 | 13 | 35 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 1 | 0 | 1 |
| ODSIS(units on a scale) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Mean | 8.90 ± 5.18 | 9.06 ± 4.84 | 8.96 ± 5.00 |
| PHQ-9(units on a scale) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Mean | 12.69 ± 6.79 | 12.89 ± 9.28 | 12.77 ± 6.67 |
| GAD-7(units on a scale) | Unified Protocol + Treatment As Usual | Treatment As Usual Alone | Total |
|---|---|---|---|
| Mean | 10.52 ± 5.13 | 9.28 ± 5.85 | 10.04 ± 5.39 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Sep 2019, 21 months.
Results were first posted in Apr 2021, 1 year 6 months after primary completion.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 21 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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