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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05296174
Other study ID # TSGH-IRB -1-102-05-019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 31, 2016
Est. completion date July 1, 2018

Study information

Verified date March 2022
Source Mackay Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Intervention

Other:
cognitive-oriented intervention program
The experimental group was offered six 40-minute courses once a week.
health education activities program
The control group was offered health education activities once a week.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Mackay Medical College National Defense Medical Center, Taiwan, Tri-Service General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
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