Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients

Substance Use Disorders Clinical Trial

— Co-ATT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187701
• Other study ID #: H-43656
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Boston Medical Center
• Contact: William-Bernard Reid-Varley, MD MPH
• Phone: 617-638-8014
• Email: William-Bernard.Reid-Varley[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Incarcerated persons
• Pregnant women
• Inability to understand and/or sign informed consent form

Related Conditions & MeSH terms

• Mental Health Issue
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Primary	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.	baseline, 12 weeks
Secondary	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	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	12 weeks
Secondary	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.	12 weeks