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NCT06091540
Feasibility and Efficacy of Individual SH+ Intervention
NA trial testing Feasibility and Efficacy of Individual SH+ Intervention in Grief Disorder, Prolonged in 37 participants. Completed in 24 December 2024.
24 December 2024
Quick facts
| Lead sponsor | Koç University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 1 October 2024 |
| Primary completion | 24 December 2024 |
| Estimated completion | 24 December 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Feasibility and Efficacy of Individual SH+ Intervention
Conditions studied
- Grief Disorder, Prolonged — all drugs for Grief Disorder, Prolonged →
Sponsor
Koç University
Who can join
Adults 18 to 65, any sex, with Grief Disorder, Prolonged. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06091540 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Koç University
- Last refreshed: 25 February 2025
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