DepressionNCT03233451
Psycho-behavioral Intervention for Depression in Chronic Heart Failure
A study testing Psycho-behavioral intervention in people with Depression, run by Peking University at 6 sites in China.
Trial summary
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Psycho-behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 6 sitesChina
- Study dates
- 1 Aug 2017to 31 Dec 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 60 -85 years old.
- male or female.
- Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
- The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
- Reading and writing competency for completing the rating scales.
- Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.
Who cannot join
- Currently taking antidepressant drugs, and drug dose is unstable.
- With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
- Intact cognitive function with CSI-D score of less than 7.
- Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
- Planned heart surgery within 9 months.
- Unable to comply with psychological intervention due to serious physical conditions -
Trial locations and contacts
6 sites in 1 country.
Ying Zhang contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Jianhua He, MD
Jianhua He, MD
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Yongdong Hu
Yongdong Hu
- Recruiting
Beijing Chaoyang Third Hospital
Beijing
Wanxin Ma
- Recruiting
Beijing Fengtai Tieying Hospital
Beijing
Peiyun Sun
Peiyun Sun
- Recruiting
Beijing Tiancun Community Health Center
Beijing
Qingling Yang
Qingling Yang
- Recruiting
Peking University Third Hospital
Beijing
Yun Zhu
Yun Zhu
About this study
Official title: Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.
Read the detailed description
Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.
- Conditions
- Depression
- Being tested
- Psycho-behavioral intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-behavioral interventionBehavioural
The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months. Receives: Behavioral: Psycho-behavioral intervention |
| control group | No intervention | Subjects will receive usual care and be contacted as same frequent as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
Measured: between baseline and week 12
Secondary outcomes (7)
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms.
Measured: between baseline and week 1, 2, 4, 8, 24 and 36
17-Item Hamilton Rating Scale for Depression
The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed).
Measured: between baseline and week 4, 8, 12, 24 and 36
Beck Depression Inventory II
The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms.
Measured: between baseline and week 1, 2, 4, 8, 12, 24 and 36
Geriatric Depression Inventory-Self-Report
The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms.
Measured: between baseline and week 4, 8, 12, 24 and 36
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
change of NT-ProBNP level
Measured: between baseline and week 12, and between baseline and week 36
cardiac function
change of ejection fraction as measured with ultrasound cardiogram
Measured: between baseline and week 12, and between baseline and week 36
Minnesota living with heart failure questionnaire
The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life.
Measured: between baseline and week 4, 8, 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
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 DepressionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huali Wang, Peking University
- Investigators
- Huali Wang, PhD, Principal investigator, Peking University Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233451
- Sponsor's protocol ID
- 2016-1-4117
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2017
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.
Publications
Zhang Y, Lv X, Jiang W, Zhu Y, Xu W, Hu Y, Ma W, Sun P, Yang Q, Liang Y, Ren F, Yu X, Wang H. Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial. BMC Psychiatry. 2019 May 27;19(1):161. doi: 10.1186/s12888-019-2135-2.
PubMed 31132996
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03233451
- Acronym / sponsor ID
- 2016-1-4117
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Jul 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.
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.
Detailed description
Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Psycho-behavioral interventionSubjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months. |
| control group | No intervention | –Subjects will receive usual care and be contacted as same frequent as the intervention group. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 60 -85 years old.
- male or female.
- Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
- The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
- Reading and writing competency for completing the rating scales.
Key exclusion criteria (6 listed)
- Currently taking antidepressant drugs, and drug dose is unstable.
- With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
- Intact cognitive function with CSI-D score of less than 7.
- Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
- Planned heart surgery within 9 months.
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 |
|---|---|---|
| Psycho-behavioral interventionThe psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support. | Behavioural | Interventional group |
Primary outcome
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
Time frame: between baseline and week 12
The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
7 secondary outcomes
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
Time frame: between baseline and week 1, 2, 4, 8, 24 and 36
17-Item Hamilton Rating Scale for Depression
Time frame: between baseline and week 4, 8, 12, 24 and 36
Beck Depression Inventory II
Time frame: between baseline and week 1, 2, 4, 8, 12, 24 and 36
Geriatric Depression Inventory-Self-Report
Time frame: between baseline and week 4, 8, 12, 24 and 36
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
Time frame: between baseline and week 12, and between baseline and week 36
cardiac function
Time frame: between baseline and week 12, and between baseline and week 36
Minnesota living with heart failure questionnaire
Time frame: between baseline and week 4, 8, 12, 24 and 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 31132996Zhang Y, Lv X, Jiang W, Zhu Y, Xu W, Hu Y, Ma W, Sun P, Yang Q, Liang Y, Ren F, Yu X, Wang H. Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial. BMC Psychiatry. 2019 May 27;19(1):161. doi: 10.1186/s12888-019-2135-2.
- Individual participant dataSharing planned: Yes. After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.
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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.
Ying Zhang contact
Huali Wang, PhD principal investigator
Peking University Institute of Mental Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-behavioral intervention in people with Depression, run by Peking University at 6 sites in China.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huali Wang, PhD (+86 010-82801983, huali_wang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version (time frame: between baseline and week 12). 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 NCT03233451, 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 9 Apr 2019.