DepressionNCT05702736
The Effect of Logotherapy-Based Intervention on Depression Patients on Depression,Psychological Pain and Meaning of Life
A study testing logotherapy-based intervention in people with Depression, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- logotherapy-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2020to 4 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having an active risk of suicide
- Having psychotic symptoms
- Having a psychiatric comorbidity
- Using antipsychotic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Logotherapy-Based Intervention on Depression Patients on Depression, Psychological Pain, and Meaning of Life: Follow-Up Study With Control Group
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.
Read the detailed description
The research was conducted to examine the effect of logotherapy-based intervention practiced to depressed patients on depression, psychological pain and meaning of life.
The research is in a quasi-experimental research design with pre-test post-test follow-up measurement, control group. Sample selection was carried out in two stages, and in the first stage, 48 patients diagnosed with depression between September 2020 and September 2022 were referred to the researcher by the polyclinic physician. The patients were evaluated within the scope of the inclusion criteria of the study, and 32 patients with a diagnosis of depression, aged 18-65 years, voluntarily aged between 18-65, who scored 17 points or more from the Beck Depression Inventory, were accepted into the study. Patients were assigned to intervention and control groups, respectively. A total of 28 patients, 12 intervention and 16 control groups, completed the study. "Descriptive Information Form", "Beck Depression Inventory", "Psychache Scale" and "Meaning of Life Questionnaire" were used as data collection tools in the study. Online logotherapy-based intervention was administered to the individuals in the intervention group as a total of eight sessions, once a week. In order to evaluate the effect of logotherapy-based intervention, Beck Depression Inventory, Psychache Scaleand Meaning of Life Questionnaire were administered to all individuals in the sample group at time series points (pretest, posttest, follow-up test at 3rd month). In the analysis of the data, descriptive statistics, independent t-test, chi-square analysis, analysis of variance in repeated measurements, Bonferroni correction were applied.
- Conditions
- Depression
- Being tested
- logotherapy-based intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
logotherapy-based interventionBehavioural
Logotherapy-based intervention was administered to the individuals in the intervention group as a total of eight sessions, once a week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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).
Measured: 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.
Measured: 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.
Measured: post-test (after 8 weeks) and follow-up test (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start4 Mar 2020
- Primary completion4 Feb 2021
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Uğuryol Ünal, Ege University
- Investigators
- Esra ENGİN, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702736
- Sponsor's protocol ID
- 20-3T/42
- Other IDs
- 20-3T/42
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2023
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Logotherapy-Based Intervention on Depression Patients on Depression, Psychological Pain, and Meaning of Life: Follow-Up Study With Control Group
- ClinicalTrials.gov ID
- NCT05702736
- Acronym / sponsor ID
- 20-3T/42
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research was conducted to examine the effect of logotherapy-based intervention practiced to depressed patients on depression, psychological pain and meaning of life.
The research is in a quasi-experimental research design with pre-test post-test follow-up measurement, control group. Sample selection was carried out in two stages, and in the first stage, 48 patients diagnosed with depression between September 2020 and September 2022 were referred to the researcher by the polyclinic physician. The patients were evaluated within the scope of the inclusion criteria of the study, and 32 patients with a diagnosis of depression, aged 18-65 years, voluntarily aged between 18-65, who scored 17 points or more from the Beck Depression Inventory, were accepted into the study. Patients were assigned to intervention and control groups, respectively. A total of 28 patients, 12 intervention and 16 control groups, completed the study. "Descriptive Information Form", "Beck Depression Inventory", "Psychache Scale" and "Meaning of Life Questionnaire" were used as data collection tools in the study. Online logotherapy-based intervention was administered to the individuals in the intervention group as a total of eight sessions, once a week. In order to evaluate the effect of logotherapy-based intervention, Beck Depression Inventory, Psychache Scaleand Meaning of Life Questionnaire were administered to all individuals in the sample group at time series points (pretest, posttest, follow-up test at 3rd month). In the analysis of the data, descriptive statistics, independent t-test, chi-square analysis, analysis of variance in repeated measurements, Bonferroni correction were applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: logotherapy-based interventionBeck 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Having an active risk of suicide
- Having psychotic symptoms
- Having a psychiatric comorbidity
- Using antipsychotic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| logotherapy-based interventionLogotherapy-based intervention was administered to the individuals in the intervention group as a total of eight sessions, once a week. | Behavioural | Intervention group |
Primary outcome
"Beck Depression Inventory" Scores
Time frame: post-test (after 8 weeks) and follow-up test (after 3 months)
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).
"Psychache Scale" Scores
Time frame: post-test (after 8 weeks) and follow-up test (after 3 months)
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.
"Meaning of Life Questionnaire" Scores
Time frame: post-test (after 8 weeks) and follow-up test (after 3 months)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra ENGİN study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing logotherapy-based intervention in people with Depression, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Beck Depression Inventory" Scores (time frame: post-test (after 8 weeks) and follow-up test (after 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.