Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients
- Conditions
- Mental Health IssueSubstance Use Disorders
- Interventions
- Behavioral: Co-Active Therapeutic Theatre (Co-ATT)
- Registration Number
- NCT06187701
- Lead Sponsor
- Boston Medical Center
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- Incarcerated persons
- Pregnant women
- Inability to understand and/or sign informed consent form
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Co-Active Therapeutic Theatre (Co-ATT) Co-Active Therapeutic Theatre (Co-ATT) Drama therapy will be used to treat participants with co-occurring primary psychiatric and substance use disorders
- Primary Outcome Measures
Name Time Method Change in substance use 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) 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 YMRS 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 subjective quality of life 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 psychiatric symptom severity given a history of bipolar disorder with the BDRS 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 for a history of post traumatic stress disorder (PTSD) 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. 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 overall functioning 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.
- Secondary Outcome Measures
Name Time Method Feasibility of the drama therapy intervention 12 weeks This outcome will be assessed by responses to an investigator developed structured interview with study staff at end of intervention.
Acceptability of the drama therapy intervention 12 weeks This outcome will be assessed by responses to an investigator developed structured interview with study staff at end of intervention.
Sustainable change in subjective quality of life 3 months, 6 months 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.
Sustainable change in substance use 3 months, 6 months 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
Sustainable change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders. 3 months, 6 months 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.
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the BDRS 3 months, 6 months 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.
Sustainable change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD) 3 months, 6 months 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.
Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the YMRS 3 months, 6 months 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.
Sustainable change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD) 3 months, 6 months 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.
Sustainable change in overall functioning 3 months, 6 months 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.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States