Effects of Cognitive-Oriented Intervention on Major Depressive Disorder

NCT ID: NCT05296174

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-01

Brief Summary

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The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan.

Detailed Description

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Background: Based on the 2010 World Health Organization declaration, depression will be ranked second among the global disease burden by 2020, second only to cardiovascular disease. It has become a disease that incurs high personal and social costs, and thus warrants considerable concern regarding its mitigation and early prevention.

Purpose: The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan.

Method: This study adopted a randomized controlled trial (RCT). Patients with major depressive disorder were recruited from acute psychiatric wards in a medical center in Northern Taiwan. The study was conducted from July 1, 2015, to December 31, 2016; 105 patients met the inclusion criteria, and 100 patients agreed to participate in the study and completed the evaluation. The participants were randomly assigned to intervention group or control group. The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks, and the control group received health education activities with the same frequency as the intervention group. All participants were assessed by questionnaires before and after the intervention. Statistical analyses were performed by using descriptive statistics, independent sample t tests, and linear multiple regression analysis.

Conditions

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Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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cognitive-oriented intervention program

The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks.

All participants were assessed by questionnaires before and after the intervention.

Group Type EXPERIMENTAL

cognitive-oriented intervention program

Intervention Type OTHER

The experimental group was offered six 40-minute courses once a week.

received health education program

The control group received health education activities with the same frequency as the intervention group.

All participants were assessed by questionnaires before and after the intervention.

Group Type ACTIVE_COMPARATOR

health education activities program

Intervention Type OTHER

The control group was offered health education activities once a week.

Interventions

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cognitive-oriented intervention program

The experimental group was offered six 40-minute courses once a week.

Intervention Type OTHER

health education activities program

The control group was offered health education activities once a week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed with MDD by a psychiatrist
* over 20 years of age
* able to speak Mandarin or Taiwanese and able to write.

Exclusion Criteria

* patients who were diagnosed with other psychiatric disorders
* with severe cognitive impairment or who could not make conversation acceptably were excluded.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Mackay Medical College

OTHER

Sponsor Role lead

Responsible Party

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Chin-Tsung Shen

The Office of Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shu-Li Cheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, Mackay Medical College

Other Identifiers

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TSGH-IRB -1-102-05-019

Identifier Type: -

Identifier Source: org_study_id

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