NCT06045637

Brief Summary

This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.After the pre-test applied to the experimental and control groups, a 9-session cognitive behavioral approach-based psychoeducation program will be applied to the experimental group.Following this application, post-test and one-month follow-up tests will be administered to both groups and the effectiveness of the psychoeducation program will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

September 13, 2023

Last Update Submit

April 17, 2024

Conditions

Keywords

emerging adulthoodcognitive emotion regulationnegative emotional symptomspsychoeducationcognitive behavioral approach

Outcome Measures

Primary Outcomes (2)

  • cognitive emotion regulation scale

    The scale consists of 36 items, with 9 subscales and 4 items in each subscale. Each subscale receives a value between 4-20 points and the scale is a 5-point Likert type scale (1: Never, 2: Sometimes, 47 3: Regularly, 4: Frequently, 5: Always).Evaluation is made with the scores obtained from the subscales. A higher score from a subscale indicates greater use of the cognitive emotion regulation strategy determined by that subscale.

    Two months

  • Depression, Anxiety, Stress Scale

    The scale consists of 21 items, with 3 sub-dimensions (depression, anxiety and stress) and 7 items in each sub-dimension. The scale is designed as a self-evaluation scale with a 4-point Likert structure scored between 0-4. (0- Never, 1- Sometimes and occasionally, 2- Quite often, 3- Always). The scoring range of the scale for depression is: 0-4 normal, 5-6 mild, 7-10 moderate, 11-13 severe, 14 and above very severe; for anxiety: 0-3 normal, 4-5 mild, 6-7 moderate, 8-9 severe, and 10 and above very severe; For stress: 0-7 is normal, 8-9 is mild, 10-12 is moderate, 13-16 is severe, 17 and above is very severe.

    Two months

Study Arms (2)

Group included in a psychoeducational program based on cognitive behavioral approach (experiment)

EXPERIMENTAL

Emerging adults between the ages of 18-29 who experienced the Kahramanmaraş 2023 earthquake in Turkey constitute the experimental group. The cognitive behavioral approach-based psychoeducation program will be implemented in 9 sessions, two days a week and 90 minutes a day.In the psychoeducation program, based on the cognitive behavioral approach, trauma and trauma symptoms, emotion-thought-behavior analysis, cognitive errors, automatic thoughts, alternative thought generation, mentality and distorted thoughts that reveal feelings of depression, anxiety, stress, anger, guilt, inadequacy, helplessness, The cognitive aspect of hopelessness and methods of coping with negative emotions will be discussed.The training program includes verbal expression, visual material (projection), question and answer, homework, sample stories, entertaining activities, warm-up games, etc. It will be continued and feedback will be shared.

Behavioral: Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)

Group not included in the psychoeducation program based on cognitive behavioral approach (Control)

NO INTERVENTION

No intervention will be made to this group.

Interventions

The 9-session cognitive behavioral approach-based psychoeducation program will last 5 weeks. Sessions; It will be carried out in the form of acquaintance, recognition of trauma and its effects, emotion and thought behavior analysis, cognitive errors, automatic thoughts and alternative thought generation, cognitive emotion regulation strategies, coping with negative emotions, instilling hope and termination session.

Group included in a psychoeducational program based on cognitive behavioral approach (experiment)

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study,
  • Being in the 18-29 age group,
  • Being at least a primary school graduate,
  • Being exposed to/having experienced the Kahramanmaraş earthquake and living in the center of Osmaniye.

You may not qualify if:

  • Having a hearing or speech disability that makes it difficult to answer surveys,
  • Participating in a similar psychoeducation program,
  • Presence of any psychiatric disorder and receiving treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

Study Officials

  • AHMET ÇAPAR, lecturer

    Osmaniye Korkut Ata University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This research was planned as a randomized controlled experimental study. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

October 23, 2023

Primary Completion

November 24, 2023

Study Completion

December 25, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations