Effects of Cognitive-Oriented Intervention on Major Depressive Disorder

Effects of Cognitive-Oriented Intervention on Perceived Social Support, Depression Symptoms, and Stress-coping Strategies in Patients With Major Depressive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Other: cognitive-oriented intervention program; Other: health education activities program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: cognitive-oriented intervention program; The experimental group was offered six 40-minute courses once a week.
Active Comparator: 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.	Other: health education activities program; The control group was offered health education activities once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS)	The MSPSS was developed by Zimet, Dahlem, Zimet and Farley (1988). It contains 12 questions, with four questions in each of three categories: (1) support from a significant other (significant other subscale); (2) support from family (family subscale); and (3) support from friends (friend subscale). This study adopts the Chinese version of the social support scale translated by Wang (2008). The higher the scale score meant the higher the perceived level of social support.	before the intervention to 6 weeks (after the intervention)
the Coping Orientations to Problems Experienced (COPE) inventory	The is a four-point scale with a total of 60 questions, including 14 subscales, which include active coping, planning, and suppression of competing activities, restraint, and use of instrumental social support, and humor are tend to problem-focused coping. The higher the score, the more often the response strategy is adopted.	before the intervention to 6 weeks (after the intervention)
The Chinese version of the Beck Depression Inventory-II (BDI-II)	The BDI-II has 21 questions. Higher scores indicated a greater degree of depression.	before the intervention to 6 weeks (after the intervention)

Collaborators and Investigators

• Sponsor: Mackay Medical College
• Collaborators: Tri-Service General Hospital; National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: Shu-Li Cheng, PhD, Department of Nursing, Mackay Medical College

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: major depressive disorder, cognitive-oriented intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: TSGH-IRB -1-102-05-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No