- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263400
Recovery Levels of Depression Patients and Caregiver Psychoeducation
The Effect Of Caregiver Psychoeducation On Recovery Levels Of Depression Patients And Family Burden And Expression Of Emotions Of Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: şerife öztaban, MsC
- Phone Number: +905557130105
- Email: serifeoztaban@gmail.com
Study Locations
-
-
Aydın/Turkey
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Aydın, Aydın/Turkey, Turkey, 09000
- Recruiting
- AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
-
Contact:
- şerife öztaban, MsC
- Phone Number: +905557130105
- Email: serifeoztaban@gmail.com
-
Sub-Investigator:
- Filiz ADANA, Phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group continued to receive the routine care
|
|
|
Experimental: Psychoeducation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week after admission
|
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pre-training caregivers
Time Frame: 1 week after admission
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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.
|
1 week after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
after training
Time Frame: 1 month 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. |
1 month after training
|
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after training
Time Frame: 3 months 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. |
3 months after training
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Şerife ÖZTABAN, MsC, AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- randomized trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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