NCT05296174

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

March 16, 2022

Last Update Submit

June 21, 2024

Conditions

Keywords

major depressive disordercognitive-oriented intervention

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

cognitive-oriented intervention program

EXPERIMENTAL

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

received health education program

ACTIVE COMPARATOR

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

Interventions

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

cognitive-oriented intervention program

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

received health education program

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients who were diagnosed with other psychiatric disorders
  • with severe cognitive impairment or who could not make conversation acceptably were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Shu-Li Cheng, PhD

    Department of Nursing, Mackay Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Office of Research and Development

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 25, 2022

Study Start

December 31, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share