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

NCT06187701 | Suspended

• 1 other identifier: H-43656
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Substance Use Disorders

Keywords

Drama therapy; Psychiatric symptom severity; Subjective quality of life; Overall functioning

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Sustainable change in substance use

  3 months, 6 months

• Sustainable change in psychiatric symptom severity for a history of Major Depressive Disorder (MDD)

  3 months, 6 months

• Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the BDRS

  3 months, 6 months

• Sustainable change in psychiatric symptom severity given a history of bipolar disorder with the YMRS

  3 months, 6 months

• Sustainable change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)

  3 months, 6 months

Study Arms (1)

Co-Active Therapeutic Theatre (Co-ATT)

EXPERIMENTAL

Drama therapy will be used to treat participants with co-occurring primary psychiatric and substance use disorders

Behavioral: Co-Active Therapeutic Theatre (Co-ATT)

Interventions

Co-Active Therapeutic Theatre (Co-ATT) BEHAVIORAL

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.

Co-Active Therapeutic Theatre (Co-ATT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• William-Bernard Reid-Varley, MD MPH

  Boston Medical Center, Psychiatry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)