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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06263400
Other study ID # randomized trial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 30, 2024

Study information

Verified date February 2024
Source Aydin Adnan Menderes University
Contact Serife ÖZTABAN, MsC
Phone +905557130105
Email serifeoztaban@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
psychoeducation and follow-up study
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.

Locations

Country Name City State
Turkey AydinAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing Aydin Aydin/Turkey

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 week after admission
Primary 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. 1 week after admission
Secondary 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
Secondary 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
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