DepressionNCT06234696
Cognitive Behavioral Therapy by Humor Based Psychoeducation
A study testing entrepreneurial intervention in people with Depression, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- entrepreneurial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Based Cognitive Behavioral Therapy by Humor Based Psychoeducation on Sense of Humour, Self Esteem and Depression Levels Patient in Diagnosed With Depression
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 .
Read the detailed description
Aim: This study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression level patient in diagnosed with depression .
Method: This study will be conducted as a randomized controlled experimental study by the researcher, who is a specialist psychiatric nurse, to the elderly patient in diagnosed with depression staying in the mardin traning and research hospital and kızıltepe state hospital. In the study, "power analysis" was performed and a total of 44 individuals, including 22 intervention people and 22 control group, were considered suitable for the sample size. It was decided to have 30 people in the groups, considering the high power of the test and the loses in the study. Accordingly, 30 people were determined as the intervention group and 30 people as the control group. In this study, personal ınformation form, coping humor scale, rosenberg self-esteem scale, beck depression scale, multidimensional sense of humor scale.
Findings: Aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression levels patient in diagnosed with depression .
- Conditions
- Depression
- Being tested
- entrepreneurial intervention
- Keywords
- cognitive behavioral therapy, depression, humor
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entrepreneurial interventionOther
The experimental group will be given psychoeducation for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: entrepreneurial intervention |
| control group | No intervention | The group consists of 30 people and this group will not be trained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Between 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start30 Dec 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Ozdemir Sigva, University of Gaziantep
- Investigators
- nurgül özdemir, Study director, 05332352154
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234696
- Sponsor's protocol ID
- AIBU-SBF-FŞ-1
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Based Cognitive Behavioral Therapy by Humor Based Psychoeducation on Sense of Humour, Self Esteem and Depression Levels Patient in Diagnosed With Depression
- ClinicalTrials.gov ID
- NCT06234696
- Acronym / sponsor ID
- AIBU-SBF-FŞ-1
- Conditions
- Depression
- Keywords
- cognitive behavioral therapy, depression, humor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Aim: This study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression level patient in diagnosed with depression .
Method: This study will be conducted as a randomized controlled experimental study by the researcher, who is a specialist psychiatric nurse, to the elderly patient in diagnosed with depression staying in the mardin traning and research hospital and kızıltepe state hospital. In the study, "power analysis" was performed and a total of 44 individuals, including 22 intervention people and 22 control group, were considered suitable for the sample size. It was decided to have 30 people in the groups, considering the high power of the test and the loses in the study. Accordingly, 30 people were determined as the intervention group and 30 people as the control group. In this study, personal ınformation form, coping humor scale, rosenberg self-esteem scale, beck depression scale, multidimensional sense of humor scale.
Findings: Aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression levels patient in diagnosed with depression .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: entrepreneurial interventionThe 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). |
| control group | No intervention | –The group consists of 30 people and this group will not be trained. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| entrepreneurial interventionThe experimental group will be given psychoeducation for 4 weeks. | Other | experimental group |
Primary outcome
Data Collection Tools Personel İnformation Form
Time frame: Between 1-3 months
Data Collection Tools Personel İnformation Form: form, organised by the researchers, includes 16 questions to determine the demograhic information of the participants.
Coping humor scale
Time frame: Between 1-3 months
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.
Multidimensional sense of humor scale
Time frame: Between 1-3 months
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.
Rosenberg self-esteem scale
Time frame: Between 1-3 months
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.
Beck depression scale
Time frame: Between 1-3 months
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.
Data Analysis
Time frame: Between 1-3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
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.
nurgül özdemir study director
05332352154
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing entrepreneurial intervention in people with Depression, run by University of Gaziantep 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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?
Results are not available in the source record.
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?
Data Collection Tools Personel İnformation Form (time frame: Between 1-3 months). The study lists 6 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 31 Jan 2024.