Feasibility and Efficacy of Individual SH+ Intervention

NCT06091540 | Completed

• 1 other identifier: 2023.292.IRB3.135
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Kessler Psychological Distress Scale (K10)

  The key parameter of interest will be the extent of psychological distress encountered by the participants, indicated by a score exceeding 15 on the Kessler Psychological Distress Scale (K10). K-10 is a 10-item scale that assesses the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate more severe psychological distress.

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

Secondary Outcomes (6)

• The Patient Health Questionnaire (PHQ-9)

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

• The Generalized Anxiety Disorder Assessment (GAD-7)

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

• The PTSD Checklist for DSM-5 (PCL-5)

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

• The Prolonged Grief Disorder Assessment (PG-13)

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

• Psychological Flexibility Scale

  Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).

Study Arms (2)

Feasibility and Efficacy of Individual SH+ Intervention

EXPERIMENTAL

The first phase of the study involves executing a pilot randomized controlled trial (RCT) with an earthquake-adapted iteration of the SH+ intervention. This phase will introduce modifications to the traditional SH+ approach. Unlike the conventional SH+ manual, which includes audio elements and paired discussions centered around specific topics, the adapted version will omit the audio components. Instead, the intervention will be delivered directly by the psychologist on a one-on-one basis. Additionally, while the original SH+ format involves paired discussions within a group setting, this study will focus on individual sessions. The intervention aims to provide a more personalized approach, promoting a more individualized and humane dimension to the healing process.

Behavioral: Feasibility and Efficacy of Individual SH+ Intervention

Treatment as Usual

NO INTERVENTION

Participants will undergo random assignment to either the treatment as usual (TAU) condition or the intervention condition. Upon completion of all measurements, the control condition will be given the opportunity to receive the intervention.

Interventions

Feasibility and Efficacy of Individual SH+ Intervention BEHAVIORAL

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.

Feasibility and Efficacy of Individual SH+ Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for participation in this study, an individual must satisfy all of the following conditions:
• Age 18 years or older
• Have directly experienced the earthquake
• Exhibit elevated levels of psychological distress, indicated by a score exceeding 15 on the Kessler Psychological Distress Scale (K10) (Kessler et al., 2002)
• Display impaired psychosocial functioning, as evidenced by a score surpassing 16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (WHO, 2010)

You may not qualify if:

• An individual meeting any of the subsequent criteria will not be included in this study:
• Presence of acute medical conditions
• Manifestation of imminent suicide risk or demonstration of acute needs/protection risks (assessed with Problem Management Plus (PM+) manual suicidality assessment)
• Affliction with severe mental disorders, such as psychotic disorders or substance dependence (assessed with PM+ manual, observation checklist),
• Experience of severe cognitive impairment, encompassing conditions like severe intellectual disability or dementia (PM+ manual observation checklist)

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Tol WA, Augustinavicius J, Carswell K, Brown FL, Adaku A, Leku MR, Garcia-Moreno C, Ventevogel P, White RG, van Ommeren M. Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda. Glob Ment Health (Camb). 2018 Jul 27;5:e25. doi: 10.1017/gmh.2018.14. eCollection 2018.

  PMID: 30128161 BACKGROUND

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ceren Acarturk, P.h.D

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to the conditions of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: October 1, 2024
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)