Mental Health IssueNCT05296174
Effects of Cognitive-Oriented Intervention on Major Depressive Disorder
A study testing cognitive-oriented intervention program and health education activities program in people with Mental Health Issue, run by Mackay Medical College.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- cognitive-oriented intervention program and health education activities program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with MDD by a psychiatrist
- over 20 years of age
- able to speak Mandarin or Taiwanese and able to write.
Who cannot join
- patients who were diagnosed with other psychiatric disorders
- with severe cognitive impairment or who could not make conversation acceptably were excluded.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- cognitive-oriented intervention program, health education activities program
- Keywords
- major depressive disorder, cognitive-oriented intervention
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-oriented intervention programOther
The experimental group was offered six 40-minute courses once a week.
health education activities programOther
The control group was offered health education activities once a week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: health education activities program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: before the intervention to 6 weeks (after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start31 Dec 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Defense Medical Center, Taiwan, Tri-Service General Hospital (TSGH)
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Shu-Li Cheng, PhD, Principal investigator, Department of Nursing, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296174
- Sponsor's protocol ID
- TSGH-IRB -1-102-05-019
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive-Oriented Intervention on Perceived Social Support, Depression Symptoms, and Stress-coping Strategies in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05296174
- Acronym / sponsor ID
- TSGH-IRB -1-102-05-019
- Conditions
- Mental Health Issue
- Keywords
- major depressive disorder, cognitive-oriented intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Collaborators
- National Defense Medical Center, Taiwan, Tri-Service General Hospital (TSGH)
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive-oriented intervention program | Experimental | Other: cognitive-oriented intervention programThe 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. |
| received health education program | Active comparator | Other: health education activities programThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with MDD by a psychiatrist
- over 20 years of age
- able to speak Mandarin or Taiwanese and able to write.
Key exclusion criteria (2 listed)
- patients who were diagnosed with other psychiatric disorders
- with severe cognitive impairment or who could not make conversation acceptably were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-oriented intervention programThe experimental group was offered six 40-minute courses once a week. | Other | cognitive-oriented intervention program |
| health education activities programThe control group was offered health education activities once a week. | Other | received health education program |
Primary outcome
the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: before the intervention to 6 weeks (after the intervention)
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.
the Coping Orientations to Problems Experienced (COPE) inventory
Time frame: before the intervention to 6 weeks (after the intervention)
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.
The Chinese version of the Beck Depression Inventory-II (BDI-II)
Time frame: before the intervention to 6 weeks (after the intervention)
The BDI-II has 21 questions. Higher scores indicated a greater degree of depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Li Cheng, PhD principal investigator
Department of Nursing, Mackay Medical College
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-oriented intervention program and health education activities program in people with Mental Health Issue, run by Mackay Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS) (time frame: before the intervention to 6 weeks (after the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.