Mental Health Issue, Substance Use Disorders
Conditions
Keywords
Drama therapy, Psychiatric symptom severity, Subjective quality of life, Overall functioning
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.
Interventions
BEHAVIORALCo-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.
Sponsors
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam-Bernard Reid-Varley, MD MPH
Boston Medical Center, Psychiatry Department
Outcome results
None listed