Contemporary Clinical Trials Communications (Feb 2024)

Islamic trauma healing (ITH): A scalable, community-based program for trauma: Cluster randomized control trial design and method

  • Lori A. Zoellner,
  • Norah C. Feeny,
  • Dega A. Angula,
  • Mohamed H. Aideed,
  • Essa N. Liban,
  • Muumin H. Egeh,
  • Abdisalan I. Awke,
  • Ahmed S. Ismail,
  • Mohamed A. Kunle,
  • Eesha Ali,
  • Carol E. Levin,
  • Christopher J. Burant,
  • Jacob A. Bentley

Journal volume & issue
Vol. 37
p. 101237

Abstract

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Background: Somalia has long been in a state of humanitarian crisis; trauma-related mental health needs are extremely high. Access to state-of-the-art mental health care is limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The 6-session intervention combines Islamic principles with empirically-supported exposure and cognitive restructuring principles for posttraumatic stress disorder (PTSD). ITH reduces training time, uses a train the trainers (TTT) model, and relies on local partnerships embedded within the strong communal mosque infrastructure. Methods: We will conduct a hybrid effectiveness-implementation randomized control trial (RCT) in the Somaliland, with implementation in the cities of Hargeisa, Borama, and Burao. In this study, a lay-led, mosque-based intervention, Islamic Trauma Healing (ITH), to promote mental health and reconciliation will be examined in 200 participants, randomizing mosques to either immediate ITH or a delayed (waitlist; WL) ITH conditions. Participants will be assessed by assessors masked to condition at pre, 3 weeks, 6 weeks, and 3-month follow-up. Primary outcome will be assessor-rated posttraumatic stress symptoms (PTSD), with secondary outcomes of depression, somatic symptoms, and well-being. A TTT model will be tested, examining the implementation outcomes. Additional measures include potential mechanisms of change and cost effectiveness. Conclusion: This trial has the potential to provide effectiveness and implementation data for an empirically-based principle trauma healing program for the larger Islamic community who may not seek mental health care or does not have access to such care. Clinical trial registration number: ClinicalTrials.gov NCT05890482. World health organization trial registration data set information: See Supplemental Appendix 1.

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