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Alternative Therapies for High Stress and Trauma-Exposed Refugees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515564
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2018
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Arash Javanbakht, Wayne State University

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE July 26, 2017
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03515564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Therapies for High Stress and Trauma-Exposed Refugees
Official Title  ICMJE Improving Emotional Well-Being by Way of Alternative Therapies for Refugees
Brief Summary Conflict in Syria and Iraq has created a humanitarian crisis that includes hundreds of thousands of refugees who have experienced trauma and suffer from a greater incidence of trauma-related disorders as compared to the general population. The need for intervention is clear: our research team has determined prevalence of probable PTSD, anxiety, and depression in adults at rates of 32.2%, 40.3% and 47.7%, respectively and children at rates of 6.3% for PTSD and 52.9% for anxiety. Barriers to treatment include cultural ideations surrounding psychiatric treatment, language barriers posed to psychotherapy, and high dropout associated exposure therapy—the standard treatment for PTSD. To overcome these challenges, the investigators developed a behavioral health program that addresses not only the psychological but also the somatic components of trauma-related disorders which are common but often less addressed by traditional treatment. This 12-week family-based program offers weekly, 90 minute sessions in Dance/Movement Therapy (DMT) or Art Therapy for children, mindful yoga for mothers, and High Intensity Interval Training (HIIT) for fathers as well as complimentary transportation to and from sessions. Self-report questionnaires and biological specimens (hair cortisol; saliva or blood inflammation markers) are collected at the beginning, middle, and end of the intervention phase, as well as 3, 6, and 12 months afterwards to measure acute and long-term effects of these treatments. By collecting psychological and biomarker data the investigators seek concrete scientific evidence supporting these non-pharmacological, cost effective, and accessible programs as reliable treatment options.
Detailed Description Exposure to traumatic events can lead to a spectrum of mental health conditions which includes but are not limited to acute stress disorder, posttraumatic stress disorder (PTSD), depression, anxiety, and somatic symptoms. Until recently, the prevalence of anxiety, depression, and trauma in Syrian and Iraqi refugees resettling in Southeast Michigan was unknown—leaving hundreds of individuals lacking proper care.The need for treatment is high, yet most refugees are unable to acquire pharmacological treatment due to lack of access to health care, or cultural beliefs. Current mainstream treatments for PTSD and anxiety disorders are focused on psychopharmacological interventions and exposure-based psychotherapies. Being at a greater risk for mental illness and facing a variety of challenges in a new country, refugees require quality and affordable care. However, traditional pharmacotherapy is not always right for every individual, and is not always culturally acceptable, nor is it affordable or accessible to everyone. Since the founding of the National Center for Complementary and Integrative Health (NCCIH) at the NIH in 1998, scientific research on and clinical application of CAMs has been increasingly conducted. As the results of longitudinal pharmacological studies become available, it seems more and more pertinent to examine the efficacy of various CAMs, such as Dance/Movement Therapy, art therapy, and yoga, to provide safer and alternative long-term treatment options to patients. Because of this, creative interventions are becoming increasingly common in psychotherapy, namely art therapy—which has been implemented in refugee populations as well as in war-torn countries but has not been clearly evaluated for its effectiveness. With a focus on the mind-body connection, these interventions may also particularly effective in addressing somatic symptoms aspects of mental illness such as pain and fatigue.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PTSD
  • Depression
  • Anxiety
  • Stress
  • Trauma
Intervention  ICMJE
  • Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT
    Utilizing deep breathing, exercise modalities, and social support in all settings
  • Behavioral: Standard Care
    Pharmacotherapy, psychotherapy
Study Arms  ICMJE
  • Experimental: Alternative therapy

    Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT

    90 minutes once weekly for 12 weeks

    Intervention: Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga, or HIIT
  • Active Comparator: Current standard care
    12 weeks of therapy or clinical care as currently standard
    Intervention: Behavioral: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 25, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
300
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female children and adults ages 7-45
  • Willing and able to consent, or with at least one parent willing and able to provide consent for minors under age 18
  • Refugees of Syria and Iraq who are not receiving any other psychiatric medical or behavioral treatment

Exclusion Criteria:

  • Adults who are unable or unwilling to consent, or children whose parent do not consent
  • Wardens of the Court
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515564
Other Study ID Numbers  ICMJE 1706000635
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arash Javanbakht, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arash Javanbakht, MD Department of Psychiatry and Behavioral Neuroscience, Wayne State University
PRS Account Wayne State University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP