Recovery Levels of Depression Patients and Caregiver Psychoeducation

NCT06263400 | Recruiting

• 1 other identifier: randomized trial
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychoeducation

Keywords

depressive disorders; Family Burden; Emotional Expression; Psychoeducation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• after training

  1 month after training

• after training

  3 months after training

Study Arms (2)

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.

Behavioral: psychoeducation and follow-up study

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

psychoeducation and follow-up study BEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Aydin, Aydın/Turkey, 09000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Interventions

Follow-Up Studies

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Şerife ÖZTABAN, MsC

  AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

  STUDY CHAIR

Central Study Contacts

Şerife ÖZTABAN, MsC

CONTACT

+905557130105; serifeoztaban@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 16, 2024
• Study Start: September 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)