Major Depressive DisorderNCT03095820
Multidomain Intervention for Older Adults With Major Depressive Disorder
A study testing Supportive therapy and Multidomain intervention in people with Major Depressive Disorder, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
To assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Supportive therapy and Multidomain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2016to 31 Jan 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of non-psychotic, unipolar major depressive disorder, based on the Mini-International Neuropsychiatric Interview
- a Montgomery-Asberg Depression Rating Scale (MADRS) score of 17 or higher
- the use of antidepressants at stable dosage for at least 6 weeks prior to study entry, without any recommendation for changes in medication for the 12 weeks of the intervention. Pharmacotherapy was uncontrolled and was provided by physicians.
Who cannot join
- a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia)
- a history of neurological disorder, such as brain tumor, intracranial hemorrhage, subarachnoid hemorrhage, epilepsy, hydrocephalus, encephalitis, metabolic encephalopathy, or other neurologic conditions that could interfere with the study
- a history of significant hearing or visual impairment
- a history of physical illnesses that could interfere with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week Multidomain Intervention With Contingency Management for Older Adults With Major Depressive Disorder: A Community-based Randomized Clinical Trial
To assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.
Read the detailed description
Awareness of the necessity and importance of community-based multidomain psychosocial intervention for late-life depression has increased. However, few studies have attempted to integrate several therapeutic approaches in one intervention program.
Main objective of this study is to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.
We plan to conduct a randomized controlled parallel-design study. We plan to allocate study participants to multidomain intervention or supportive therapy group, in a 1:1 ratio. Block randomization using SAS (PLAN procedure) and sample size estimation were performed. We estimated that, with at least 40 participants per group and an attrition rate of 10%, we could achieve a power of at least 0.80 (beta = 0.2, two-tailed alpha = 0.05).
Intervention was based on the financial and human resources of a community mental health service, and involved four home visits and 12 telephone calls over 12 weeks. Four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the multidomain intervention program. To maintain participant motivation, we plan to apply contingency management based on operant conditioning theory.
The primary outcome is the change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondarily, we plan to investigate changes in resting-state functional connectivity in the default mode, salience, and central executive networks.
- Conditions
- Major Depressive Disorder
- Being tested
- Supportive therapy, Multidomain intervention
- Keywords
- Community, Depressive Symptoms, Mental Health Program, Older adults
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive therapyBehavioural
Multidomain interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Supportive therapy | Active comparator | The control group received supportive therapy for 12 weeks. In addition to a telephone call once a week and a home visit once a month, this program consisted of identification of physical problems, encouragement of general exercise, encouragement of pleasant activities, and so forth. The control program did not feature any specific goal setting by the participants, specific education about the benefits of achievement of such goals, or symbolic prizes. Receives: Behavioral: Supportive therapy |
| Multidomain intervention | Experimental | As a multidomain intervention, four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the program.
In terms of the healthy diet intervention, we encouraged participants to perform at least 30 min of above-moderate physical activity, three times per week. In terms of the healthy diet intervention, the intervention consisted of encouraging participants to consume high quantities of fish, olive oil, legumes, vegetables, and fruit, at a frequency of at least twice a week. In terms of the social activity intervention, we encouraged participants to participate in social organizations, such as the senior center, the hall of the elderly, a fraternity, a reunion, and a clan gathering, at least once a week. In terms of the emotional regulation intervention, we a performed brief cognitive restructuring task for 20 min per visit. Receives: Behavioral: Multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale(MADRS)
Change from baseline depressive symptoms at 4, 8, 12 weeks
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (1)
resting-state fMRI
brain functional connectivity
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Mar 2016
- Primary completion31 Dec 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel-design study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Joon Son, Ajou University School of Medicine
- Investigators
- Sang Joon Son, MD,PhD, Principal investigator, Ajou Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095820
- Sponsor's protocol ID
- AJIRB-SBR-SUR-15-132
- Status last verified
- Aug 2018
- First submitted
- 21 Mar 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roh HW, Hong CH, Lim HK, Chang KJ, Kim H, Kim NR, Choi JW, Lee KS, Cho SM, Park B, Son SJ. A 12-week multidomain intervention for late-life depression: a community-based randomized controlled trial. J Affect Disord. 2020 Feb 15;263:437-444. doi: 10.1016/j.jad.2019.12.013. Epub 2019 Dec 9.
PubMed 31969275
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Multidomain Intervention With Contingency Management for Older Adults With Major Depressive Disorder: A Community-based Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03095820
- Acronym / sponsor ID
- AJIRB-SBR-SUR-15-132
- Conditions
- Major Depressive Disorder
- Keywords
- Community, Depressive Symptoms, Mental Health Program, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 30 Mar 2017 (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.
To assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.
Detailed description
Awareness of the necessity and importance of community-based multidomain psychosocial intervention for late-life depression has increased. However, few studies have attempted to integrate several therapeutic approaches in one intervention program.
Main objective of this study is to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.
We plan to conduct a randomized controlled parallel-design study. We plan to allocate study participants to multidomain intervention or supportive therapy group, in a 1:1 ratio. Block randomization using SAS (PLAN procedure) and sample size estimation were performed. We estimated that, with at least 40 participants per group and an attrition rate of 10%, we could achieve a power of at least 0.80 (beta = 0.2, two-tailed alpha = 0.05).
Intervention was based on the financial and human resources of a community mental health service, and involved four home visits and 12 telephone calls over 12 weeks. Four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the multidomain intervention program. To maintain participant motivation, we plan to apply contingency management based on operant conditioning theory.
The primary outcome is the change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondarily, we plan to investigate changes in resting-state functional connectivity in the default mode, salience, and central executive networks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled parallel-design study
| Arm | Type | Receives |
|---|---|---|
| Supportive therapy | Active comparator | Behavioral: Supportive therapyThe control group received supportive therapy for 12 weeks. In addition to a telephone call once a week and a home visit once a month, this program consisted of identification of physical problems, encouragement of general exercise, encouragement of pleasant activities, and so forth. The control program did not feature any specific goal setting by the participants, specific education about the benefits of achievement of such goals, or symbolic prizes. |
| Multidomain intervention | Experimental | Behavioral: Multidomain interventionAs a multidomain intervention, four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the program. In terms of the healthy diet intervention, we encouraged participants to perform at least 30 min of above-moderate physical activity, three times per week. In terms of the healthy diet intervention, the intervention consisted of encouraging participants to consume high quantities of fish, olive oil, legumes, vegetables, and fruit, at a frequency of at least twice a week. In terms of the social activity intervention, we encouraged participants to participate in social organizations, such as the senior center, the hall of the elderly, a fraternity, a reunion, and a clan gathering, at least once a week. In terms of the emotional regulation intervention, we a performed brief cognitive restructuring task for 20 min per visit. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of non-psychotic, unipolar major depressive disorder, based on the Mini-International Neuropsychiatric Interview
- a Montgomery-Asberg Depression Rating Scale (MADRS) score of 17 or higher
- the use of antidepressants at stable dosage for at least 6 weeks prior to study entry, without any recommendation for changes in medication for the 12 weeks of the intervention. Pharmacotherapy was uncontrolled and was provided by physicians.
Key exclusion criteria (4 listed)
- a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia)
- a history of neurological disorder, such as brain tumor, intracranial hemorrhage, subarachnoid hemorrhage, epilepsy, hydrocephalus, encephalitis, metabolic encephalopathy, or other neurologic conditions that could interfere with the study
- a history of significant hearing or visual impairment
- a history of physical illnesses that could interfere with the study.
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 |
|---|---|---|
| Supportive therapy | Behavioural | Supportive therapy |
| Multidomain intervention | Behavioural | Multidomain intervention |
Primary outcome
Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline depressive symptoms at 4, 8, 12 weeks
1 secondary outcome
resting-state fMRI
Time frame: Baseline, 12 weeks
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 22 Aug 2018.
- Derived from this study: PubMed 31969275Roh HW, Hong CH, Lim HK, Chang KJ, Kim H, Kim NR, Choi JW, Lee KS, Cho SM, Park B, Son SJ. A 12-week multidomain intervention for late-life depression: a community-based randomized controlled trial. J Affect Disord. 2020 Feb 15;263:437-444. doi: 10.1016/j.jad.2019.12.013. Epub 2019 Dec 9.
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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.
Sang Joon Son, MD,PhD principal investigator
Ajou Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive therapy and Multidomain intervention in people with Major Depressive Disorder, run by Ajou University School of Medicine at 1 site in South Korea.
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 4 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Montgomery-Asberg Depression Rating Scale(MADRS) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095820, which also lists 1 linked publication.
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 22 Aug 2018.