PsychoeducationNCT06263400
Recovery Levels of Depression Patients and Caregiver Psychoeducation
A study testing psychoeducation and follow-up study in people with Psychoeducation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychoeducation
- What is being tested?
- psychoeducation and follow-up study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 Dec 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient selection criteria included in the sample for the research;
- Being 18 years or older
- Receiving inpatient treatment with a diagnosis of F32 (Depressive Disorder) or F33 (Recurrent Depressive Disorder)
- Does not have a developmental disorder
- Without psychotic features
- Not having communication problems
Show all 10Show fewer
- Being at least a primary school graduate Caregiver selection criteria included in the sample for the research;
- Being 18 years or older
- Being the primary caregiver of the patient
- Being at least a primary school graduate
Who cannot join
- • Patient selection criteria for exclusion from the sample for the research;
- DSM-V Axis I comorbidity Caregiver selection criteria for exclusion from the sample for the research;
- With mental retardation or psychotic disorder
- Having speech and hearing disorders
- It was created as having one of the diagnoses of a cognitive disorder such as delirium, dementia, or amnestic syndrome.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
Aydin, Aydın/Turkey, 09000
şerife öztaban, MsC, +905557130105, serifeoztaban@gmail.com
Filiz ADANA, Phd
About this study
Official title: The Effect Of Caregiver Psychoeducation On Recovery Levels Of Depression Patients And Family Burden And Expression Of Emotions Of Caregivers
To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels.
Read the detailed description
The samples of the research are 'The experiment that was followed up in the inpatient service at Adnan Menderes University Research and Practice Hospital Psychiatry Service with diagnoses of F32 (Depressive Disorder according to ICD 10 code) and F33 (Recurrent Depressive Disorder according to ICD 10 code) and met the inclusion criteria for the study (n = 46). ) and a control group (n=46) with a total of 92 depression patients and their caregivers. The experimental group patients and their caregivers and their relatives were included in the psychoeducation program application within the framework of the training recommended in the "Guide for the Treatment of Patients with Major Depressive Disorder" published by APA in 2010. This application is a psychosocial treatment program consisting of structured sessions and including an experiential interactional process. Data were collected from patients using the Beck Depression Scale, Recovery Assessment Scale; It was collected by caregivers using the Emotional Expression Scale and Zarit Family Burden Scale.
- Conditions
- Psychoeducation
- Being tested
- psychoeducation and follow-up study
- Keywords
- depressive disorders, Family Burden, Emotional Expression, Psychoeducation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducation and follow-up studyBehavioural
In the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | Experimental:Experimental group ın the first meeting with the patients and their caregivers in the experimental group, information about the training was given, information about the patient was obtained, and training days were determined.Structured education and follow-up In the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family.Structured education and follow-up In the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family. Receives: Behavioral: psychoeducation and follow-up study |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
to patients before training
Depressive symptoms of the patients will be evaluated with the 'Beck Depression Scale'. The scale was developed in 1961, and its Turkish validity and reliability study was conducted in 1989. The scale, which includes the physical, emotional, cognitive and motivational symptoms seen in depression, aims to objectively determine the degree of depression symptoms. It is stated that as the score obtained from the scale increases, the severity of depression also increases. The subjective recovery processes of the patients will be evaluated with the 'recovery evaluation scale'. Turkish validity and reliability study was conducted in 2017. The scale is a 24-item, 5-point Likert type scale. A high total score obtained from the scale indicates that the improvement is high.
Measured: 1 week after admission
pre-training caregivers
The 'healing evaluation scale', a scale consisting of 41 items that determines the emotional expression style and level of patient relatives, was developed in 1993. As the scores increase on the scale, which is answered as "True (1)-False (0)" and is rated between 0-1, the level of emotional expression increases. High scores from the scale are interpreted as a high level of negative reflection of the caregiver's emotional expression, and low scores mean a low level of negative reflection of the caregiver's emotional expression. 'Zarit family burden scale' was developed in 1980, and the Turkish validity and reliability study of the scale was conducted in 2009. The scale consists of 22 statements and is a 5-point Likert type scale. High scores from the scale are interpreted as a high burden level of the caregiver, and low scores mean a low burden level.
Measured: 1 week after admission
Secondary outcomes (2)
after training
The Beck depression scale will be used to determine the degree of depression symptoms. The recovery assessment scale will be used to evaluate the subjective recovery processes of depression patients.
Emotional expression scale will be used to determine caregivers' emotional expression style and level. Zarit family burden scale will be used to measure the burden level of caregivers.
Measured: 1 month after training
after training
The Beck depression scale will be used to determine the degree of depression symptoms. The recovery assessment scale will be used to evaluate the subjective recovery processes of depression patients.
Emotional expression scale will be used to determine caregivers' emotional expression style and level. Zarit family burden scale will be used to measure the burden level of caregivers.
Measured: 3 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Sep 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychoeducationStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Oztaban, Aydin Adnan Menderes University
- Investigators
- Şerife ÖZTABAN, MsC, Study chair, AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263400
- Sponsor's protocol ID
- randomized trial
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Caregiver Psychoeducation On Recovery Levels Of Depression Patients And Family Burden And Expression Of Emotions Of Caregivers
- ClinicalTrials.gov ID
- NCT06263400
- Acronym / sponsor ID
- randomized trial
- Conditions
- Psychoeducation
- Keywords
- depressive disorders, Family Burden, Emotional Expression, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Feb 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.
To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels.
Detailed description
The samples of the research are 'The experiment that was followed up in the inpatient service at Adnan Menderes University Research and Practice Hospital Psychiatry Service with diagnoses of F32 (Depressive Disorder according to ICD 10 code) and F33 (Recurrent Depressive Disorder according to ICD 10 code) and met the inclusion criteria for the study (n = 46). ) and a control group (n=46) with a total of 92 depression patients and their caregivers. The experimental group patients and their caregivers and their relatives were included in the psychoeducation program application within the framework of the training recommended in the "Guide for the Treatment of Patients with Major Depressive Disorder" published by APA in 2010. This application is a psychosocial treatment program consisting of structured sessions and including an experiential interactional process. Data were collected from patients using the Beck Depression Scale, Recovery Assessment Scale; It was collected by caregivers using the Emotional Expression Scale and Zarit Family Burden Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: psychoeducation and follow-up studyExperimental:Experimental group ın the first meeting with the patients and their caregivers in the experimental group, information about the training was given, information about the patient was obtained, and training days were determined.Structured education and follow-up In the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family.Structured education and follow-up In the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient selection criteria included in the sample for the research;
- Being 18 years or older
- Receiving inpatient treatment with a diagnosis of F32 (Depressive Disorder) or F33 (Recurrent Depressive Disorder)
- Does not have a developmental disorder
- Without psychotic features
Key exclusion criteria (5 listed)
- • Patient selection criteria for exclusion from the sample for the research;
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 |
|---|---|---|
| psychoeducation and follow-up studyIn the study, we hypothesized that the caregiver psychoeducation program (consisting of six sessions over a 3-week period) would improve depressive symptoms in depressed patients, increase recovery levels, reduce the caregiver's burden, and reduce emotional expression levels in the family. | Behavioural | Psychoeducation |
Primary outcome
to patients before training
Time frame: 1 week after admission
Depressive symptoms of the patients will be evaluated with the 'Beck Depression Scale'. The scale was developed in 1961, and its Turkish validity and reliability study was conducted in 1989. The scale, which includes the physical, emotional, cognitive and motivational symptoms seen in depression, aims to objectively determine the degree of depression symptoms. It is stated that as the score obtained from the scale increases, the severity of depression also increases. The subjective recovery processes of the patients will be evaluated with the 'recovery evaluation scale'. Turkish validity and reliability study was conducted in 2017. The scale is a 24-item, 5-point Likert type scale. A high total score obtained from the scale indicates that the improvement is high.
pre-training caregivers
Time frame: 1 week after admission
The 'healing evaluation scale', a scale consisting of 41 items that determines the emotional expression style and level of patient relatives, was developed in 1993. As the scores increase on the scale, which is answered as "True (1)-False (0)" and is rated between 0-1, the level of emotional expression increases. High scores from the scale are interpreted as a high level of negative reflection of the caregiver's emotional expression, and low scores mean a low level of negative reflection of the caregiver's emotional expression. 'Zarit family burden scale' was developed in 1980, and the Turkish validity and reliability study of the scale was conducted in 2009. The scale consists of 22 statements and is a 5-point Likert type scale. High scores from the scale are interpreted as a high burden level of the caregiver, and low scores mean a low burden level.
2 secondary outcomes
after training
Time frame: 1 month after training
after training
Time frame: 3 months after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Related trials for Psychoeducation
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
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.
Şerife ÖZTABAN, MsC study chair
AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation and follow-up study in people with Psychoeducation, run by Aydin Adnan Menderes 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 10 inclusion and 5 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 16 Feb 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?
Contact Şerife ÖZTABAN, MsC (+905557130105, serifeoztaban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to patients before training (time frame: 1 week after admission). The study lists 2 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 16 Feb 2024.