Mental Health IssueCo-ATTNCT06187701
Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients
A study testing Co-Active Therapeutic Theatre (Co-ATT) in people with Mental Health Issue and Substance Use Disorders, run by Boston Medical Center at 1 site in United States.
Trial summary
Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue, Substance Use Disorders
- What is being tested?
- Co-Active Therapeutic Theatre (Co-ATT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with at least one primary psychiatric disorder, and
- Diagnosed with at least one substance use disorder
- Both disorders active (i.e., meeting DSM-V criteria for each disorder (i.e., with ongoing psychiatric symptoms and ongoing substance use)
- Enrolled in the Addiction Psychiatry Treatment Program (APTP) at Boston Medical Center (i.e., scheduled for follow-up appointments with therapist and/or psychiatrist in APTP).
- Currently taking medications and those not currently taking medications
Who cannot join
- Incarcerated persons
- Pregnant women
- Inability to understand and/or sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Use of the Co-Active Therapeutic Theatre (Co-ATT) Manualised Model of Drama Therapy for the Treatment of Patients With Co-occurring Primary Psychiatric and Substance Use Disorders
Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing.
This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful).
The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.
- Conditions
- Mental Health Issue, Substance Use Disorders
- Being tested
- Co-Active Therapeutic Theatre (Co-ATT)
- Keywords
- Drama therapy, Psychiatric symptom severity, Subjective quality of life, Overall functioning
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Active Therapeutic Theatre (Co-ATT)Behavioural
There will be one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Co-Active Therapeutic Theatre (Co-ATT) | Experimental | Drama therapy will be used to treat participants with co-occurring primary psychiatric and substance use disorders Receives: Behavioral: Co-Active Therapeutic Theatre (Co-ATT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in substance use
Assessed with the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool. TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. TAPS Score Risk Category- 0=No Use in Past 3 Months, 1=Problem Use, 2+ =Higher Risk
Measured: baseline, 12 weeks
Change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD)
The Patient Health Questionnaire (PHQ) will be used to assess this outcome. It is a multiple-choice self-report inventory that is used as a screening and diagnostic tool for mental health disorders of depression, anxiety, alcohol, eating, and somatoform disorders.There are 9 questions with a score from 0=Not al all to 3=Nearly everyday and one additional question about level of difficulty. Scores can range from 1 to 27 and are interpreted as: 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, and 20-27 Severe depression.
Measured: baseline, 12 weeks
Change in psychiatric symptom severity given a history of bipolar disorder with the BDRS
The Bipolar Depression Rating Scale (BDRS) has 20 questions with responses from 0= Nil to 3= Severe. The maximum score possible is 60. Higher scores indicate greater severity of symptoms.
Measured: baseline, 12 weeks
Change in psychiatric symptom severity given a history of bipolar disorder with the YMRS
The Young Mania Rating Scale (YMRS) has eleven items and is based on the patient's subjective report of his or her clinical condition, and generally limited to the previous 48 hours. Scores can range from 0 to 60 and higher scores are associated with more severe symptoms.
Measured: baseline, 12 weeks
Change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to assess this outcome. The total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
Measured: baseline, 12 weeks
Change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders.
The Positive and Negative Syndrome Scale (PANSS) will be used to asses this outcome. PANSS items are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme); because the absence of symptoms is equal to 1 point, the lowest possible total score on both PANSS scales is 7. The range for both the negative and positive scales are 7 to 49.
Measured: baseline, 12 weeks
Change in subjective quality of life
The Quality of Life Scale (QOLS) will be used to assess this outcome. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Higher score indicate higher quality of life.
Measured: baseline, 12 weeks
Change in overall functioning
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will be used to assess overall functioning. The WHODAS 2.0 questionnaire comprises six domains with a five-point Likert-type scale (1 = no difficulty, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) to measure the difficulty in performing activities. HIgher scores are associated with more disability.
Measured: baseline, 12 weeks
Secondary outcomes (10)
Sustainable change in substance use
Assessed with the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool. TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. TAPS Score Risk Category- 0=No Use in Past 3 Months, 1=Problem Use, 2+ =Higher Risk
Measured: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD)
The Patient Health Questionnaire (PHQ) will be used to assess this outcome. It is a multiple-choice self-report inventory that is used as a screening and diagnostic tool for mental health disorders of depression, anxiety, alcohol, eating, and somatoform disorders.There are 9 questions with a score from 0=Not al all to 3=Nearly everyday and one additional question about level of difficulty. Scores can range from 1 to 27 and are interpreted as: 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, and 20-27 Severe depression.
Measured: 3 months, 6 months
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the BDRS
The Bipolar Depression Rating Scale (BPDS) has 20 questions with responses from 0= Nil to 3= Severe. The maximum score possible is 60. Higher scores indicate greater severity of symptoms.
Measured: 3 months, 6 months
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the YMRS
The Young Mania Rating Scale (YMRS) has eleven items and is based on the patient's subjective report of his or her clinical condition, and generally limited to the previous 48 hours. Scores can range from 0 to 60 and higher scores are associated with more severe symptoms.
Measured: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to assess this outcome. The total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
Measured: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders.
The Positive and Negative Syndrome Scale (PANSS) will be used to asses this outcome. PANSS items are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme); because the absence of symptoms is equal to 1 point, the lowest possible total score on both PANSS scales is 7. The range for both the negative and positive scales are 7 to 49.
Measured: 3 months, 6 months
Sustainable change in subjective quality of life
The Quality of Life Scale (QOLS) will be used to assess this outcome. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Higher score indicate higher quality of life.
Measured: 3 months, 6 months
Sustainable change in overall functioning
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will be used to assess overall functioning. The WHODAS 2.0 questionnaire comprises six domains with a five-point Likert-type scale (1 = no difficulty, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) to measure the difficulty in performing activities. HIgher scores are associated with more disability.
Measured: 3 months, 6 months
Feasibility of the drama therapy intervention
This outcome will be assessed by responses to an investigator developed structured interview with study staff at end of intervention.
Measured: 12 weeks
Acceptability of the drama therapy intervention
This outcome will be assessed by responses to an investigator developed structured interview with study staff at end of intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Funding has not yet been obtained to conduct this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William-Bernard Reid-Varley, MD MPH, Principal investigator, Boston Medical Center, Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187701
- Sponsor's protocol ID
- H-43656
- Acronym
- Co-ATT
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Use of the Co-Active Therapeutic Theatre (Co-ATT) Manualised Model of Drama Therapy for the Treatment of Patients With Co-occurring Primary Psychiatric and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06187701
- Acronym / sponsor ID
- Co-ATT / H-43656
- Conditions
- Mental Health Issue, Substance Use Disorders
- Keywords
- Drama therapy, Psychiatric symptom severity, Subjective quality of life, Overall functioning
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding has not yet been obtained to conduct this study.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing.
This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful).
The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co-Active Therapeutic Theatre (Co-ATT) | Experimental | Behavioral: Co-Active Therapeutic Theatre (Co-ATT)Drama therapy will be used to treat participants with co-occurring primary psychiatric and substance use disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with at least one primary psychiatric disorder, and
- Diagnosed with at least one substance use disorder
- Both disorders active (i.e., meeting DSM-V criteria for each disorder (i.e., with ongoing psychiatric symptoms and ongoing substance use)
- Enrolled in the Addiction Psychiatry Treatment Program (APTP) at Boston Medical Center (i.e., scheduled for follow-up appointments with therapist and/or psychiatrist in APTP).
- Currently taking medications and those not currently taking medications
Key exclusion criteria (3 listed)
- Incarcerated persons
- Pregnant women
- Inability to understand and/or sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-Active Therapeutic Theatre (Co-ATT)There will be one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention. | Behavioural | Co-Active Therapeutic Theatre (Co-ATT) |
Primary outcome
Change in substance use
Time frame: baseline, 12 weeks
Assessed with the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool. TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. TAPS Score Risk Category- 0=No Use in Past 3 Months, 1=Problem Use, 2+ =Higher Risk
Change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD)
Time frame: baseline, 12 weeks
The Patient Health Questionnaire (PHQ) will be used to assess this outcome. It is a multiple-choice self-report inventory that is used as a screening and diagnostic tool for mental health disorders of depression, anxiety, alcohol, eating, and somatoform disorders.There are 9 questions with a score from 0=Not al all to 3=Nearly everyday and one additional question about level of difficulty. Scores can range from 1 to 27 and are interpreted as: 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, and 20-27 Severe depression.
Change in psychiatric symptom severity given a history of bipolar disorder with the BDRS
Time frame: baseline, 12 weeks
The Bipolar Depression Rating Scale (BDRS) has 20 questions with responses from 0= Nil to 3= Severe. The maximum score possible is 60. Higher scores indicate greater severity of symptoms.
Change in psychiatric symptom severity given a history of bipolar disorder with the YMRS
Time frame: baseline, 12 weeks
The Young Mania Rating Scale (YMRS) has eleven items and is based on the patient's subjective report of his or her clinical condition, and generally limited to the previous 48 hours. Scores can range from 0 to 60 and higher scores are associated with more severe symptoms.
Change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)
Time frame: baseline, 12 weeks
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to assess this outcome. The total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
Change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders.
Time frame: baseline, 12 weeks
The Positive and Negative Syndrome Scale (PANSS) will be used to asses this outcome. PANSS items are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme); because the absence of symptoms is equal to 1 point, the lowest possible total score on both PANSS scales is 7. The range for both the negative and positive scales are 7 to 49.
Change in subjective quality of life
Time frame: baseline, 12 weeks
The Quality of Life Scale (QOLS) will be used to assess this outcome. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Higher score indicate higher quality of life.
Change in overall functioning
Time frame: baseline, 12 weeks
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will be used to assess overall functioning. The WHODAS 2.0 questionnaire comprises six domains with a five-point Likert-type scale (1 = no difficulty, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) to measure the difficulty in performing activities. HIgher scores are associated with more disability.
10 secondary outcomes
Sustainable change in substance use
Time frame: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD)
Time frame: 3 months, 6 months
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the BDRS
Time frame: 3 months, 6 months
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the YMRS
Time frame: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)
Time frame: 3 months, 6 months
Sustainable change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders.
Time frame: 3 months, 6 months
Sustainable change in subjective quality of life
Time frame: 3 months, 6 months
Sustainable change in overall functioning
Time frame: 3 months, 6 months
Feasibility of the drama therapy intervention
Time frame: 12 weeks
Acceptability of the drama therapy intervention
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William-Bernard Reid-Varley, MD MPH principal investigator
Boston Medical Center, Psychiatry Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-Active Therapeutic Theatre (Co-ATT) in people with Mental Health Issue and Substance Use Disorders, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in substance use (time frame: baseline, 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.