Recovery Levels of Depression Patients and Caregiver Psychoeducation

February 15, 2024 updated by: Serife Oztaban, Aydin Adnan Menderes University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Aydın/Turkey
      • Aydın, Aydın/Turkey, Turkey, 09000
        • Recruiting
        • AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
        • Contact:
        • Sub-Investigator:
          • Filiz ADANA, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Şerife ÖZTABAN, MsC, AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

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)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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