NCT06234696

Brief Summary

This study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self-esteem and depressıon level patient in diagnosed with deppression .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 4, 2024

Last Update Submit

January 28, 2024

Conditions

Keywords

cognitive behavioral therapydepressionhumor

Outcome Measures

Primary Outcomes (6)

  • Data Collection Tools Personel İnformation Form

    Data Collection Tools Personel İnformation Form: form, organised by the researchers, includes 16 questions to determine the demograhic information of the participants.

    Between 1-3 months

  • Coping humor scale

    Coping humor scale: The scale is a 4-point Likert-tybe scale (1: Strongly disagree - 4: Completely agree) consisting of 7 items. The lowest score to be obtained from the scale 7 and the highest score is 28. Rising scores indicate that individuals have a higher level of ability to use humor as a coping strategy in stressful situations.

    Between 1-3 months

  • Multidimensional sense of humor scale

    Multidimensional sense of humor scale:The scale consists of a total of 24 items and four subscales. The items in the scale are avaluated using 5- point likert tybe scale (0= strongly disagree, 4 = strongly agree) The lowest score to be obtained from the scale 0 and the highest score is 96.In addition to a general sense of humor score, the scale has 4 subscales: producing humor, coping using humor, attitude towards people who produce humor, and humor evaluation.

    Between 1-3 months

  • Rosenberg self-esteem scale

    Rosenberg self-esteem scale: The scale consists of total 63 items and 12 subscales.In our study, only the part of the scale related to self-esteem will be used. The self-esteem subscale is a Likert-type subscale consisting of 4 items and includes the first 10 items of the inventory. Each statement contains 4-point Likert type options (4=very true, 3=true,2= false,1= very false). When evaluating, in positive statements, the "very true" option is 4 points, the "very wrong" option is 1 point; For negative expressions, the calculation was made exactly the opposite. Depending on the evaluation method of the scale, 0-6 points can be obtained. Thus, the person who completes the test can get a maximum of 6 points in total. 5-6 points were determined as low self-esteem, 2-4 points as medium self-esteem, and 0-1 points as high self-esteem.

    Between 1-3 months

  • Beck depression scale

    Beck depression scale: This scale consists of 21 items and each item has four options. The four options in each symptom category of the scale receive a score between 0 and 3. The highest score that can be obtained from the scale is 63. A high total score indicates a high level or severity of depression symptoms.10-17 points from the scale indicate mild depression, 18-29 points indicate moderate depression, and 30-63 points indicate severe depression.

    Between 1-3 months

  • Data Analysis

    Data Analysis: The data obtained from the study will be analysed in Statistical Packkage for Social Sciences 22 package programme. Repeated Measures Analysis Of Variance was used to compare the scale scores and Fisher Least Significant Difference test was used for multiple comparisons of Group Time interaction

    Between 1-3 months

Study Arms (2)

experimental group

EXPERIMENTAL

The group consists of 30 people and this group will be given psychoeducation for 4 weeks. Training will be provided 2 days a week (monday and friday).

Other: entrepreneurial intervention

control group

NO INTERVENTION

The group consists of 30 people and this group will not be trained.

Interventions

The experimental group will be given psychoeducation for 4 weeks.

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • Not having any obstacle to communication
  • Being between the ages of 18 and 65
  • Being monitored on an outpatient basis with a diagnosis of depression according to the diagnostic and statistical manual of mental disorders criteria
  • Being literate
  • Not having undergone such training in the last 6 months

You may not qualify if:

  • Serious factors that may prevent you from answering the survey
  • Presence of physical and cognitive disability
  • Refusing to participate in the study after being informed
  • Having a comorbid psychiatric diagnosis
  • A patient diagnosed with depression with psychotic features
  • Having received any psychotherapy in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima

Mardin, 47000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • nurgül özdemir

    05332352154

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatric Nurse

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 31, 2024

Study Start

December 30, 2022

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations