Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population. (MOOD)

• ClinicalTrials.gov Identifier: NCT05989412
• Recruitment Status: Not yet recruiting
• First Posted: August 14, 2023
• Last Update Posted: January 31, 2024
• Sponsor: Erasmus Medical Center
• Information provided by (Responsible Party): Inge MCM de Kok, Erasmus Medical Center

Tracking Information

• First Submitted Date: May 9, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: January 31, 2024
• Estimated Study Start Date: February 1, 2024
• Estimated Primary Completion Date: September 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2024)

Quality of life scores after 12 months [ Time Frame: 12 months ]

Primary outcomes of the trial include participants' quality of life after 12 months as measured by the EQ-5D-5L between intervention and no intervention. Although only 3 out of 5 items on this questionnaire relate to mental problems and social functioning, evidence suggests that it is highly sensitive to MDD when used in community research settings (Short et al., 2021). Because the fifth question (''How anxious or depressed are you today?'') of the EQ-5D has the strongest relation with mental health, we will report outcomes on that question separately as well.

Original Primary Outcome Measures (submitted: August 9, 2023)

Quality of life scores over time [ Time Frame: 24 months ]

Primary outcomes of the trial include participants' quality of life after 24 months as measured by the EQ-5D-5L. EQ-5D-5L will also be assessed at baseline, and again at 6 and 12 months. The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher digit number means a worse outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Current Secondary Outcome Measures (submitted: January 30, 2024)

Major depressive disorder symptoms [ Time Frame: 12 months ]

The investigators will also examine the occurrence and severity of symptoms as measured by the PHQ-9. If participants are not referred to their GP due to one or three consecutive positive test scores on PHQ-9 during the 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups. Furthermore, population differences will be evaluated based on socio-demographic characteristics (including age, gender, ethnicity, education level, and employment status). The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression including 9 questions and a 4-scale-based answer option (Not at all, Several days, More than half the days, Nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Scores on the PHQ-9 range from 0 to 27. A higher score means a worse outcome

Original Secondary Outcome Measures (submitted: August 9, 2023)

Major depressive disorder symptoms [ Time Frame: 12 months ]

The investigators will also examine the occurrence and severity of symptoms as measured by the PHQ-9. If participants are not referred to their GP due to one or three consecutive positive test scores on PHQ-9 during the course of the 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression including 9 questions and a 4-scale-based answer option (Not at all, Several days, More than half the days, Nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Scores on the PHQ-9 range from 0 to 27. A higher score means a worse outcome

Current Other Pre-specified Outcome Measures (submitted: January 30, 2024)

Quality of life follow up [ Time Frame: 24 months ]

Other study parameters include participants' quality of life after 24 months as measured by the EQ-5D-5L between two intervention groups and the control group. It will also provide information regarding the duration and severity of MDD symptoms across participants in both screening arms. Furthermore, the risk of measuring differences in referrals between two intervention groups will also be evaluated by comparing both screening arms.

Original Other Pre-specified Outcome Measures (submitted: August 9, 2023)

Screening adherence [ Time Frame: 12 months ]

Measurements of participation

Descriptive Information

• Brief Title: Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.
• Official Title: Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.
• Brief Summary: Major depressive disorder (MDD) is a mental disorder leading to a variety of emotional and physical problems affecting almost 300 million people worldwide. Long-term treatments for MDD, including medication and therapy, imposes a significant financial burden on society. Mobile-based screening interventions might be a promising approach for effectively reducing MDD symptoms. The investigators hypothesize that the mobile-based screening strategy evaluated in this proposal will substantially reduce the burden of MDD over time, increase participants' quality of life, and decrease MDD-related disparities

Detailed Description

The MOOD trial is designed as a prospective, randomized controlled multi-arm trial with three parallel groups: an intervention group that will be screened 4-weekly for MDD for 12 months and receives a referral for MDD diagnosis and treatment after one positive test score on the PHQ-9, an intervention group who will be screened the same as the first group but receives a referral for MDD diagnosis and treatment after three consecutive positive test scores on the PHQ-9 and a control group who do not receive mobile-based screening for MDD. Randomization will be performed by the Your Research application as block randomization with a 2:1:1 allocation and stratification for age, gender and living area.

The intervention will be powered to demonstrate an effect on quality of life after 12 months with 80% power at a 5% significance threshold. It assumes that averted MDD will result in a 0.40 improvement in quality of life and that frequent screening will be effective in 40% of participants with MDD. Furthermore, we conservatively assume a cumulative incidence of MDD during 12 months of 10%, based on a three times increased rate of unemployment in the intervention area and therefore three times increased risk of developing MDD. An additional adjustment for an assumed 40% spontaneously remission rate within 12 months was applied. With a correlation coefficient of 0.8, the design effect for using the baseline measurement becomes 0.36. Therefore, 714 people are required in control and combined intervention arms. Yielding a total sample size of 1,428 people (2:1:1 randomization). The intervention will be powered to demonstrate an effect on quality of life with 80% power at a 5% significance threshold. To compensate for the potential 20% differential loss of follow-up in both arms due to adverse events, we aim to recruit an additional 179 participants for the control arm and 179 participants for the intervention arm (1:1 between both intervention groups). To reach our goal we therefore need 1786 participants.

Participants will follow the individual screening procedure through the application platform Your Research. Participants will be invited to create a secured personal account, after which they can log in through a website on their computer/laptop or by installing the Your Research app on their tablet or mobile phone. There will be a variety of platforms provided for additional inquiries about the study process, including video calls, chat options, and phone calls.

Participants will be recruited through different online and offline strategies to encourage citizens' participation according to different cultural backgrounds. Offline recruitment includes in-person interactions with community members referred to be "key figures", posting flyers in GP offices and municipal buildings, video promotion, presentations, and by addressing people personally in public areas. Online recruitment postings will be made on websites, social media networks, and local radio stations.

Interested individuals can enroll by visiting the study website, or by initiating an application procedure through the Your Research app. If preferred, contacting the investigators through phone or email is also possible. Eligible participants will subsequently be provided with the patient information form (PIF) as well as an informed consent form. Participants who complete and return the signed consent form will be enrolled and randomized in the trial. The informed consent procedure is conducted digitally by using ValidSign. After randomization, participants will complete the baseline assessment.

Recruitment will be closely monitored to ensure that the sample size will be reached. If the sample size is attained, inclusion tactics will be discontinued. Furthermore, to ensure that questionnaire assessments are completed and that participants remain in the study, researchers will automatically send reminders via several contact channels based on the participants' preferences (email, push notifications, SMS). Participants will be compensated for their participation at the end of the study. Depending on the study arm and the number of completed questionnaires the participants can earn up to €50 in gift cards. Participants have the option to withdraw from the study at any moment during the trial. Recruitment will take place between January 2024 and December 2024.

Primary and secondary outcome measures for the MOOD study will be collected using mobile-based questionnaires. Data can be collected throughout the study and stored using encrypted digital files within password-protected folders with access limited to a restricted number of researchers. To protect confidentiality, participants will be granted a unique participant identification number upon registration. This number, as well as the associated personal information, is only available to the lead investigator and team members under their supervision. Contact information will be kept separate from any other research data gathered throughout the study. After the study is finished, all data will be safely archived for 15 years within Erasmus Medical Center. Once all outcome data has been collected, it will be exported to a statistics program. Members of the research team will examine and clean the data. All data will be kept and stored in accordance with the Personal Data Protection Act.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The investigators will randomize 1786 eligible respondents across three arms, in a 2:1:1 fashion. The three arms comprise a control arm, a screening arm with limited participant referral for treatment (after three positive test scores on Patient Health questionnaire-9 (PHQ-9) or suicidal ideation), and a screening arm with standard referral for participants with moderate-severe symptoms of major depression (single positive test score on PHQ-9 questionnaire).

Masking: None (Open Label)
Primary Purpose: Screening

• Condition: Major Depressive Disorder

Intervention

Other: Patient health questionnaire-9 via the Your Research application

Both intervention arms will have 4-weekly screening with either lenient follow-up or screening with stricter follow-up for a time period of one year. Data will be collected via an app designed by Your Research which runs on Microsoft Azure server, as the primary of participants' response collection. A dedicated backup system will serve as a secondary data collection.

Study Arms

• No Intervention: Control arm
  a control arm where the investigators will only measure the quality of life using the EQ-5D questionnaire. This measurement will be performed at the same time as both screening arms.
• Experimental: Standard referral
  a screening arm with standard participant referral for diagnosis at the general practitioner's office (after 1 positive test score on the PHQ-9 questionnaire or suicidal ideation).
  Intervention: Other: Patient health questionnaire-9 via the Your Research application
• Experimental: Limited referral
  a screening arm with limited participant referral for diagnosis at the general practitioner's office (after three consecutive positive test scores on the PHQ-9 questionnaire or suicidal ideation).
  Intervention: Other: Patient health questionnaire-9 via the Your Research application

Publications *

• Abdoli N, Salari N, Darvishi N, Jafarpour S, Solaymani M, Mohammadi M, Shohaimi S. The global prevalence of major depressive disorder (MDD) among the elderly: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2022 Jan;132:1067-1073. doi: 10.1016/j.neubiorev.2021.10.041. Epub 2021 Nov 4.
• Almeida OP. Prevention of depression in older age. Maturitas. 2014 Oct;79(2):136-41. doi: 10.1016/j.maturitas.2014.03.005. Epub 2014 Mar 22.
• Gotlib IH, Goodman SH, Humphreys KL. Studying the Intergenerational Transmission of Risk for Depression: Current Status and Future Directions. Curr Dir Psychol Sci. 2020 Apr 1;29(2):174-179. doi: 10.1177/0963721420901590. Epub 2020 Feb 24.
• Hall CA, Reynolds-Iii CF. Late-life depression in the primary care setting: challenges, collaborative care, and prevention. Maturitas. 2014 Oct;79(2):147-52. doi: 10.1016/j.maturitas.2014.05.026. Epub 2014 Jun 7.
• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
• Kalibatseva Z, Leong FT. Depression among Asian Americans: Review and Recommendations. Depress Res Treat. 2011;2011:320902. doi: 10.1155/2011/320902. Epub 2011 Sep 27.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Liu Q, He H, Yang J, Feng X, Zhao F, Lyu J. Changes in the global burden of depression from 1990 to 2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2020 Jul;126:134-140. doi: 10.1016/j.jpsychires.2019.08.002. Epub 2019 Aug 10.
• O'Connor EA, Whitlock EP, Beil TL, Gaynes BN. Screening for depression in adult patients in primary care settings: a systematic evidence review. Ann Intern Med. 2009 Dec 1;151(11):793-803. doi: 10.7326/0003-4819-151-11-200912010-00007.
• Park LT, Zarate CA Jr. Depression in the Primary Care Setting. N Engl J Med. 2019 Feb 7;380(6):559-568. doi: 10.1056/NEJMcp1712493.
• Posternak MA, Miller I. Untreated short-term course of major depression: a meta-analysis of outcomes from studies using wait-list control groups. J Affect Disord. 2001 Oct;66(2-3):139-46. doi: 10.1016/s0165-0327(00)00304-9.
• Rohde P, Lewinsohn PM, Klein DN, Seeley JR, Gau JM. Key Characteristics of Major Depressive Disorder Occurring in Childhood, Adolescence, Emerging Adulthood, Adulthood. Clin Psychol Sci. 2013 Jan;1(1):10.1177/2167702612457599. doi: 10.1177/2167702612457599.
• Siu AL; US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, Garcia FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392.
• Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.
• Steensma C, Loukine L, Orpana H, McRae L, Vachon J, Mo F, Boileau-Falardeau M, Reid C, Choi BC. Describing the population health burden of depression: health-adjusted life expectancy by depression status in Canada. Health Promot Chronic Dis Prev Can. 2016 Oct;36(10):205-213. doi: 10.24095/hpcdp.36.10.01.
• Whiteford HA, Harris MG, McKeon G, Baxter A, Pennell C, Barendregt JJ, Wang J. Estimating remission from untreated major depression: a systematic review and meta-analysis. Psychol Med. 2013 Aug;43(8):1569-85. doi: 10.1017/S0033291712001717. Epub 2012 Aug 10.
• Yildiz B, Schuring M, Knoef MG, Burdorf A. Chronic diseases and multimorbidity among unemployed and employed persons in the Netherlands: a register-based cross-sectional study. BMJ Open. 2020 Jul 2;10(7):e035037. doi: 10.1136/bmjopen-2019-035037.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 30, 2024): 1786
• Original Estimated Enrollment (submitted: August 9, 2023): 1575
• Estimated Study Completion Date: September 2026
• Estimated Primary Completion Date: September 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At least 18 years old Live in Rotterdam Zuid
• Have a smartphone
• Give informed consent

Exclusion Criteria:

- Is currently treated by a psychologist or psychiatrist for depressive symptoms

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Michelle Zandbergen, Msc; +31621509410; m.zandbergen@erasmusmc.nl

Contact: Erik Jansen, Msc; +31 6 48931356; e.e.l.jansen@erasmusmc.nl

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05989412
• Other Study ID Numbers: NL84280.078.23
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Data of participants that did not grant permission to reuse their data for future research will have to be removed. Furthermore, further pseudonymisation and/or aggregation of the pseudonymised dataset would be required to secure the privacy of the participants and avoid indirect identification.

The accessibility of the collected data could be important for potential follow-up research of this project and/or similar national/international projects that would like to perform analyses on our data because not much is known yet on the implementation of screening for MDD.

• Supporting Materials: Study Protocol
• Time Frame: The data will be published within 10 months and will be available from then on.
• Access Criteria: Open source publication

• Current Responsible Party: Inge MCM de Kok, Erasmus Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Erasmus Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Inge de Kok, PhD; Erasmus Medical Center

• PRS Account: Erasmus Medical Center
• Verification Date: January 2024