Alternative Therapies for High Stress and Trauma-Exposed Refugees
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|ClinicalTrials.gov Identifier: NCT03515564|
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2018
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD Depression Anxiety Stress Trauma||Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT Behavioral: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Emotional Well-Being by Way of Alternative Therapies for Refugees|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Alternative therapy
Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT
90 minutes once weekly for 12 weeks
Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT
Utilizing deep breathing, exercise modalities, and social support in all settings
Active Comparator: Current standard care
12 weeks of therapy or clinical care as currently standard
Behavioral: Standard Care
- PTSD symptoms (children) [ Time Frame: 12 weeks ]Evaluation of PTSD related symptoms. UCLA Trauma Questionnaire administered to children. 33 items ranked from 0-4, with 0 = none of the time to 4 = most of the time. Scores can be summed for a composite score, with a maximum of 132 and a minimum of 0, or determination of PTSD criteria met utilizing responses to individual questions.
- PTSD symptoms (adults) [ Time Frame: 12 weeks ]PCL-c for DSM V (Post-traumatic stress disorder checklist for civilians). 20 questions ranked from 0 to 4 for "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." Maximum score = 80, minimum score = 0. A score of 33 or higher appears reasonable to propose possible PTSD. Diagnostic criteria can also be evaluated by assessing responses to individual questions.
- Depressive symptoms (adults) [ Time Frame: 12 weeks ]Hopkins Symptoms Checklist - 25. Evaluates depressive and anxiety related symptoms in adults. Responses: ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively. Anxiety score is the average of the first ten questions; depressive score is the average of the last 15 questions. For either measure, scores greater than 1.75 are said to be symptomatic. Highest score = 4; lowest score = 0.
- Depressive Symptoms (Children) [ Time Frame: 12 weeks ]Mood and Feelings Questionnaire (long form). 33 questions to assess depressive symptoms, ranked from 0 to 2. Highest score = 66 and lowest = 0; score of 27 or higher is said to be indicative of possible depression. 0 = not true, 1 = sometimes true, and 2 = true.
- Anxiety Symptoms (Children) [ Time Frame: 12 weeks ]Screen for Child Anxiety Related Emotional Disorders. 41 item questionnaire. 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Maximum score = 82; minimum score = 0. Scores are summed.
- Somatic Symptoms (adults and children) [ Time Frame: 12 weeks ]Somatic symptoms scale, 8 items. Ranks somatic symptoms on a scale from 0 to 4, with the following possible scoring results: no to minimal (0-3 points), low (4-7 points), medium (8-11 points), high (12-15 points), and very high (16-32 points) somatic symptom burden
- Inflammatory State [ Time Frame: 12 weeks ]measure via saliva or blood
- Cortisol [ Time Frame: 12 weeks ]measure via hair
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515564
|United States, Michigan|
|Wayne State U Department of Psychiatry|
|Detroit, Michigan, United States, 48197|
|Principal Investigator:||Arash Javanbakht, MD||Department of Psychiatry and Behavioral Neuroscience, Wayne State University|