Major Depressive DisorderNCT05577494
A Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
An observational study of Major Depressive Disorder and Mobile Health, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Mobile Health
- What is being tested?
- Questionnaire online
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 31 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects of clinicians come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji University, whose age, working years, and gender are different. Subjects of outpatients come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji University who have been definitely diagnosed as MDD and are in stable condition. Their age is between 12 and 65 years old, and the number of children and adolescents aged 12 to 18 years old is not less than one third of the total sample size of patients. In addition, they have junior high school education and above, as well as adequate audio-visual skills, and can fully understand the informed consent form and interview content.
Who may be able to join
- Recruited clinicians who are on the job and they come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Shanghai Tongji Hospital
- Recruited clinicians are of different ages, working years and genders;
- Recruited clinicians understand the research content and sign the informed consent form
- Recruited patients should be definitely diagnosed as "MDD" in their outpatient records, and those patients are in a stable state of illness and can cooperate in completing the questionnaire survey or accepting the focus group discussion;
- Recruited patients have junior high school education or above, as well as adequate audio-visual skills, and can fully understand the informed consent form and interview content.
- The age of the recruited patients is 12-65 years, and the number of children and adolescents aged 12-18 years is not less than one third of the total sample size of patients;
- The enrolled patients or the guardian of them can understand the research content and sign the informed consent form.
Who cannot join
- Recruited clinicians are unable to conduct effective verbal conversation;
- Recruited clinicians are unable to cooperate or complete other situations of the interview.
- Recruited patients who have obvious violent attacks or tendencies;
- Recruited patients who are in the attack or unstable period of illness;
- There is a serious tendency to commit suicide;
- Recruited patients who are unable to conduct effective verbal conversation;
- Recruited patients who cannot cooperate or complete other situation of the interview.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: A Cluster Randomized Controlled Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
Read the detailed description
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. Therefore, we present a trial protocol for a 2-arm cluster randomized controlled trial (RCT) with a hybrid implementation-effectiveness design comparing standard MBC implementation versus eMBC implementation with 6-month follow up in 12 mental health centers in Shanghai, China. The eMBC implementation uses a WeChat mini-program that includes outcome tracking using brief questionnaires and self-management lessons supplemented with support by a lay coach via WeChat. The primary implementation outcome is implementation reach, defined as the proportion of eligible patients with a PHQ-9 score recorded in the hospital chart at 6 months after MBC implementation. The primary clinical outcome is clinical remission, defined as a PHQ-9 score of 4 or less at the 6-month follow up. Other implementation and clinical outcomes will be examined, including medication adherence, doctor-patient alliance, and a piggy-back cost-benefit economic analysis. Qualitative interviews will be conducted with physicians and patients to produce an interpretive account of the contextual factors which impact eMBC implementation. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
- Conditions
- Major Depressive Disorder, Mobile Health
- Being tested
- Questionnaire online
- Keywords
- major depressive disorder, measurement-based care, mobile health
- 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.
Questionnaire onlineOther
Also called Semi-structured interviews, Focus group discussion
Questionnaire online: all subjects will receive an online questionnaire and complete the Clinician Questionnaire.
Semi-structured interviews: semi-structured interviews are conducted with the clinician interviewers using the Clinician Interview Guide.
Focus group discussion: Focus group discussions are conducted with patients according to the Patient Focus Group Symposium Manual.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians | Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 100 clinicians are recruited in total. Then, they will receive an online questionnaire and complete the Clinician Questionnaire. Finally, the survey results need to be qualitatively analyzed. Receives: Other: Questionnaire online | |
| Clinician interviewers | Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 30 clinicians are recruited in total (10 in each clinical institution). Each clinical institution shall select 2-3 interviewers, who shall participate in interview consistency training. Semi-structured interviews are conducted with the enrolled clinicians using the Clinician Interview Guide. The interview process needs to be recorded, and the interview results need to be qualitatively analyzed. | |
| Outpatients with MDD: | Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 600 patients with MDD are recruited in outpatient clinics (200 in each institution). The patient questionnaire will be completed online. The enrolled patients need to conduct an online questionnaire survey and complete the Patient Questionnaire. Finally, the survey results need to be qualitatively analyzed. Receives: Other: Questionnaire online | |
| Patients with MDD receiving focus group discussion | Each center will hold 1-2 focus group symposiums for 8-10 patients according to the Patient Focus Group Symposium Manual. The content of the symposium needs to be recorded and written. Finally, the interview results need to be qualitatively analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
judge the key barriers and promoting factors of the follow-up experiment implementation.
Through the qualitative method of focus group interviews with clinicians and patients, the specific factors hindering the implementation of eMBC by doctors and patients, and the direction of follow-up specific intervention will be identified. Through the quantitative method of online survey of doctors and patients, the population to be implemented in the following second stage, the content and frequency of full course follow-up will be determined, and the specific definition of depression on the full course model will be improved.
Measured: 1years, anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Chen, Study chair, Shanghai Mental Health CenterJinhua Sun, Study chair, Children's Hospital of Fudan UniversityQingwei Li, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577494
- Sponsor's protocol ID
- SHDC120120126
- Status last verified
- Sep 2022
- First submitted
- 9 Oct 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
- ClinicalTrials.gov ID
- NCT05577494
- Acronym / sponsor ID
- SHDC120120126
- Conditions
- Major Depressive Disorder, Mobile Health
- Keywords
- major depressive disorder, measurement-based care, mobile health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Tongji Hospital
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Oct 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.
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
Detailed description
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. Therefore, we present a trial protocol for a 2-arm cluster randomized controlled trial (RCT) with a hybrid implementation-effectiveness design comparing standard MBC implementation versus eMBC implementation with 6-month follow up in 12 mental health centers in Shanghai, China. The eMBC implementation uses a WeChat mini-program that includes outcome tracking using brief questionnaires and self-management lessons supplemented with support by a lay coach via WeChat. The primary implementation outcome is implementation reach, defined as the proportion of eligible patients with a PHQ-9 score recorded in the hospital chart at 6 months after MBC implementation. The primary clinical outcome is clinical remission, defined as a PHQ-9 score of 4 or less at the 6-month follow up. Other implementation and clinical outcomes will be examined, including medication adherence, doctor-patient alliance, and a piggy-back cost-benefit economic analysis. Qualitative interviews will be conducted with physicians and patients to produce an interpretive account of the contextual factors which impact eMBC implementation. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinicians | – | Other: Questionnaire onlineThree hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 100 clinicians are recruited in total. Then, they will receive an online questionnaire and complete the Clinician Questionnaire. Finally, the survey results need to be qualitatively analyzed. |
| Clinician interviewers | – | –Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 30 clinicians are recruited in total (10 in each clinical institution). Each clinical institution shall select 2-3 interviewers, who shall participate in interview consistency training. Semi-structured interviews are conducted with the enrolled clinicians using the Clinician Interview Guide. The interview process needs to be recorded, and the interview results need to be qualitatively analyzed. |
| Outpatients with MDD: | – | Other: Questionnaire onlineThree hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 600 patients with MDD are recruited in outpatient clinics (200 in each institution). The patient questionnaire will be completed online. The enrolled patients need to conduct an online questionnaire survey and complete the Patient Questionnaire. Finally, the survey results need to be qualitatively analyzed. |
| Patients with MDD receiving focus group discussion | – | –Each center will hold 1-2 focus group symposiums for 8-10 patients according to the Patient Focus Group Symposium Manual. The content of the symposium needs to be recorded and written. Finally, the interview results need to be qualitatively analyzed. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects of clinicians come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji University, whose age, working years, and gender are different. Subjects of outpatients come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji University who have been definitely diagnosed as MDD and are in stable condition. Their age is between 12 and 65 years old, and the number of children and adolescents aged 12 to 18 years old is not less than one third of the total sample size of patients. In addition, they have junior high school education and above, as well as adequate audio-visual skills, and can fully understand the informed consent form and interview content.
Key inclusion criteria (7 listed)
- Recruited clinicians who are on the job and they come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Shanghai Tongji Hospital
- Recruited clinicians are of different ages, working years and genders;
- Recruited clinicians understand the research content and sign the informed consent form
- Recruited patients should be definitely diagnosed as "MDD" in their outpatient records, and those patients are in a stable state of illness and can cooperate in completing the questionnaire survey or accepting the focus group discussion;
- Recruited patients have junior high school education or above, as well as adequate audio-visual skills, and can fully understand the informed consent form and interview content.
Key exclusion criteria (7 listed)
- Recruited clinicians are unable to conduct effective verbal conversation;
- Recruited clinicians are unable to cooperate or complete other situations of the interview.
- Recruited patients who have obvious violent attacks or tendencies;
- Recruited patients who are in the attack or unstable period of illness;
- There is a serious tendency to commit suicide;
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 |
|---|---|---|
| Questionnaire onlineAlso: Semi-structured interviews, Focus group discussionQuestionnaire online: all subjects will receive an online questionnaire and complete the Clinician Questionnaire. Semi-structured interviews: semi-structured interviews are conducted with the clinician interviewers using the Clinician Interview Guide. Focus group discussion: Focus group discussions are conducted with patients according to the Patient Focus Group Symposium Manual. | Other | Clinicians, Outpatients with MDD: |
Primary outcome
judge the key barriers and promoting factors of the follow-up experiment implementation.
Time frame: 1years, anticipated
Through the qualitative method of focus group interviews with clinicians and patients, the specific factors hindering the implementation of eMBC by doctors and patients, and the direction of follow-up specific intervention will be identified. Through the quantitative method of online survey of doctors and patients, the population to be implemented in the following second stage, the content and frequency of full course follow-up will be determined, and the specific definition of depression on the full course model will be improved.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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.
Jun Chen study chair
Shanghai Mental Health Center
Jinhua Sun study chair
Children's Hospital of Fudan University
Qingwei Li study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Mobile Health, run by Shanghai Mental Health Center at 1 site 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 7 inclusion and 7 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 13 Dec 2022. 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 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 Jun Chen (021-34773011, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
judge the key barriers and promoting factors of the follow-up experiment implementation. (time frame: 1years, anticipated). 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 13 Dec 2022.