跳至主要内容
临床试验/NCT06187701
NCT06187701尚未招募不适用

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

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
2
主要终点
Change in substance use

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Co-Active Therapeutic Theatre (Co-ATT)

Experimental

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

干预措施: Co-Active Therapeutic Theatre (Co-ATT) (Behavioral)

结局指标

主要结局

Change in substance use

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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.

时间窗: 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

时间窗: 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.

次要结局

  • Feasibility of the drama therapy intervention(12 weeks)
  • Acceptability of the drama therapy intervention(12 weeks)
  • Sustainable change in subjective quality of life(3 months, 6 months)
  • Sustainable change in substance use(3 months, 6 months)
  • Sustainable change in psychiatric symptom severity for a history of schizophrenia/schizophrenic disorders.(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 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 YMRS(3 months, 6 months)
  • Sustainable change in psychiatric symptom severity for a history of post traumatic stress disorder (PTSD)(3 months, 6 months)
  • Sustainable change in overall functioning(3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验