Clinical trial NCT05296174: Effects of Cognitive-Oriented Intervention on Major Depressive Disorder
Official title: Effects of Cognitive-Oriented Intervention on Perceived Social Support, Depression Symptoms, and Stress-coping Strategies in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: major depressive disorder
cognitive-oriented intervention
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
Collaborators: name: National Defense Medical Center, Taiwan
name: Tri-Service General Hospital
First posted: 2022-03-25
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: before the intervention to 6 weeks (after the intervention)
measure: the Coping Orientations to Problems Experienced (COPE) inventory
timeFrame: before the intervention to 6 weeks (after the intervention)
measure: The Chinese version of the Beck Depression Inventory-II (BDI-II)
timeFrame: before the intervention to 6 weeks (after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nursing, Mackay Medical College
name: Shu-Li Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: