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Feasibility and Efficacy of Individual SH+ Intervention

NCT06091540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-02-25

No results posted yet for this study

Summary

The central aim of this research is to execute a randomized controlled trial (RCT) to assess the impact and effectiveness of the individually-delivered SH+ intervention among earthquake survivors in Türkiye. The principal focus lies in investigating the potential benefits of the intervention. The key parameter of interest will be the extent of psychological distress encountered by the participants. In addition, various secondary outcomes will also be evaluated, encompassing depression, anxiety, post-traumatic stress disorder (PTSD) symptoms, psychosocial well-being, and grief levels. The evaluation of the intervention's effectiveness on the sample of interest will hinge on the comparison of scores obtained during the pretest and posttest measurement phases. It is hypothesized that scores will exhibit a decline following the participants' engagement with the SH+ program over the span of five weeks. Specifically, the hypothesis being tested posits that there will be a notable reduction in depression, anxiety, post-traumatic stress, psychological distress, psychosocial impairment, and grief scores during the post-assessment stage in contrast to the pre-assessment stage. It is expected that the experimental condition and the control condition will demonstrate significant differences in depression, anxiety, post-traumatic stress, psychosocial impairment, and grief scores. The primary outcome measure of psychological distress will show a statistically significant difference between the experimental and control groups at both the immediate posttest assessment and the 3-month follow-up assessment.

Conditions

  • Grief Disorder, Prolonged

Interventions

BEHAVIORAL

Feasibility and Efficacy of Individual SH+ Intervention

The key parameter of interest will be the extent of psychological distress encountered by the participants. In addition, various secondary outcomes will also be evaluated, encompassing depression, anxiety, post-traumatic stress disorder (PTSD) symptoms, psychosocial well-being, and grief levels. The evaluation of the intervention's effectiveness on the sample of interest will hinge on the comparison of scores obtained during the pretest and posttest measurement phases.

Sponsors & Collaborators

  • Koç University

    lead OTHER

Principal Investigators

  • Ceren Acarturk, P.h.D · Koç University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2024-12-24
Completion
2024-12-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091540 on ClinicalTrials.gov