NCT05702736

Brief Summary

The goal of this interventional study is to compare in logotherapy-based intervention practiced to depressed patients on depression, psychological pain and meaning of life. The main questions it aims to answer are:

  • Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in reducing the depression levels of the patients?
  • Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in reducing the psychological pain levels of the patients?
  • Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in increasing the patients' level of meaning to life? Participants will be done online interview once a week for eight sessions. Researchers will compare intervention and control groups to see if logotherapy-based intervention practiced effect depression, psychological pain and meaning of life levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

January 8, 2023

Results QC Date

September 16, 2024

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • "Beck Depression Inventory" Scores

    Beck Depression Inventory (BDI) The inventory measures depression level.The inventory assesses physical, emotional, cognitive and motivational components. The four-point Likert-type scale comprises of 21 questions. The scale has a minimum score of 0 and a maximum score of 63. As the total score increases, the depression level also increases. The scale score graded depression into four levels: normal (0-9 points), mild (10-16 points), moderate (17-29 points) and severe (30-63 points).

    post-test (after 8 weeks) and follow-up test (after 3 months)

  • "Psychache Scale" Scores

    Psychache Scale was developed to assess psychological pain. The five-point Likert-type scale consists of 13 questions. The scale has a minimum score of 13 and a maximum score of 65. As the total score increases, the psychache level increases.

    post-test (after 8 weeks) and follow-up test (after 3 months)

  • "Meaning of Life Questionnaire" Scores

    Meaning of Life Questionnaire measures the level of meaning that individuals give to life.This seven-point Likert-type scale consists of 10 questions.The scale has a minimum score of 10 and a maximum score of 70. The scale has two subscales. These subscales include the existing meaning in life (5 questions) and the search for meaning in life (5 questions).The total score is obtained by summing the subscale scores. As the total score of the scale increases, individuals' level of meaning in life increases.

    post-test (after 8 weeks) and follow-up test (after 3 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

Beck Depression Inventory, Psychache Scale, Meaning of Life Questionnaire was applied to intervention group as a pre-test. Inaddition to the Standard treatment, the intervention group received a logotherapy-based intervention. Beck Depression Inventory, Psychache Scale, Meaning of Life Questionnaire was applied to intervention group as a post test and follow up test.

Behavioral: logotherapy-based intervention

Control group

NO INTERVENTION

Beck Depression Inventory, Psychache Scale, Meaning of Life Questionnaire was applied to control group as a pre-test. The control group received only standard treatment. Beck Depression Inventory, Psychache Scale, Meaning of Life Questionnaire was applied to control group as a post test and follow up test.

Interventions

Logotherapy-based intervention was administered to the individuals in the intervention group as a total of eight sessions, once a week.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 18-65
  • Having been diagnosed with depression
  • A score of 17 or higher on the Beck Depression Inventory
  • Willingness and willingness to participate in the research
  • Completed at least six interviews

You may not qualify if:

  • Having an active risk of suicide
  • Having psychotic symptoms
  • Having a psychiatric comorbidity
  • Using antipsychotic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Nursing

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

It is among the limitations that the patients in the intervention and control groups can experience improvement thanks to the use of psychiatric drugs other than logotherapy-based applications. The research was conducted during the Covid-19 pandemic. Face-to-face meetings were held online. Again, depression levels may have been affected since patients had to be forced to stay at home. These possibilities are among the limitations of the research.

Results Point of Contact

Title
Dr. Merve UGURYOL UNAL
Organization
Ege University

Study Officials

  • Esra ENGİN

    Ege University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Phd Student

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 27, 2023

Study Start

March 4, 2020

Primary Completion

February 4, 2021

Study Completion

September 4, 2022

Last Updated

April 8, 2025

Results First Posted

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations