UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051630 |
|---|---|
| Receipt number | R000058916 |
| Scientific Title | Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2025/07/20 11:02:27 |
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Basic information
Public title
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Acronym
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title:Acronym
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Mental Health
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine attrition and adherence rates in interventions using digital health technology as primary prevention of mental health outcomes among workers, by intervention content and participant characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
attrition and adherence
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Studies including any type of employees/workers as "population"
- Studies applying any type of non-pharmacological interventions aiming at primary prevention using digital health technologies (eg., exercises, diet, lifestyle, psychological intervention such as cognitive behavioral therapy) as "intervention"
- Studies applying any type of control conditions as "comparison"
- Studies assessing effectiveness using specific outcomes including mental health conditions, positive mental health, and work-related outcomes as "outcomes"
- Studies addressed information on attrition and/or adherence
- Studies using randomized controlled trial design
- Studies published after 2010
Key exclusion criteria
- Studies targeting participants who have any specific disorder.
- Studies including participants who are not employees/workers.
- Studies applying any type of interventions aiming at secondary or tertiary prevention.
- Studies aiming to evaluate treatment effects of interventions on specific disorders or symptoms
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Kanamori |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211(46215)
satoru_kanamori@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Kanamori |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211(46215)
Homepage URL
satoru_kanamori@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University, Graduate School of Public Health, Satoru Kanamori
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee
Address
2-11-1 Kaga Itabashi-ku, Tokyo, Japan
Tel
03-3964-7256(42203)
turb-office@teikyo-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/joh/advance-article/doi/10.1093/joccuh/uiaf035/8178234
Number of participants that the trial has enrolled
8
Results
Results: Eight studies were included in the systematic review, and five in the meta-analysis. Pooled effect sizes immediately after intervention were as follows: Cohen's d = -0.51 (95% CI: -0.75, -0.27) for depression and negative affect, and -0.36 (-0.60, -0.05) for perceived stress. The attrition rate was 16.8% and 12.4% for the control and intervention groups, with only two studies providing details on adherence.
Results date posted
| 2025 | Year | 07 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
One study was published in 2011, one in 2015, two in 2020, one in 2021, one in 2022, and two in 2023. The study designs comprised five RCTs, one 3-arm RCT, one 4-arm RCT, and one cluster RCT. Regarding geographic distribution, three studies were conducted in the United States, three in the United Kingdom, one in Spain, and one in Turkey. Sample sizes varied from a minimum of 183 to a maximum of 553 participants.
Three intervention studies focused on the promotion of physical activity:
A 15 to 30-minute aerobic exercise program during lunch breaks aiming to reduce stress symptoms and fatigue while improving sleep quality. As part of the DHT intervention, a mobile application was used to record activity status, and email was utilized for communication with the instructor.
The "Get Moving" website provided personalized physical activity plans for sedentary employees, aiming to enhance motivation and knowledge.
The CARE study implemented a multi-level, workplace-based intervention targeting childcare staff, with the goal of promoting physical activity. The DHT intervention included an interactive website for goal setting and self-monitoring, as well as e-mail communication for providing customized feedback.
Two intervention studies focused on the promotion of yoga:
A six-week online yoga program aiming to reduce stress and enhance the well-being of individuals working from home. The intervention utilized DHT, such as live-streamed sessions and online platforms for participation, engagement, and instructor interaction.
A laughter yoga program was conducted to improve the psychological resilience and sleep quality of nurses. Zoom was used to conduct the laughter yoga sessions, while WhatsApp facilitated fast and easy communication among the experimental group, including session-related discussions.
One intervention study focused on promoting walking:
A 10-week program implemented 30-minute group-led lunchtime walks three times a week to enhance workplace relaxation and enthusiasm among physically inactive employees. DHT was utilized to support the intervention through a poll for walk sign-ups, motivational text messages to enhance engagement, and programmed mobile phones that randomly scheduled measurement days and sent alarms for assessments of job affect and workload.
Two intervention studies focused on the reduction of sedentary behavior:
A height-adjustable desk and an online behavioral intervention program were implemented in a remote work setting to reduce sedentary time and enhance mental health and productivity.
An e-health intervention for office workers utilized computer-based prompts to interrupt prolonged sitting, aiming to increase physical activity and improve vascular function.
The types of DHT used in the interventions were electronic messaging (five studies), websites (two studies), online meetings or counseling (two studies), apps (two studies), and computer-based software (one study). The control groups were either waiting lists or had no intervention (seven studies), and active controls (one study). The outcomes examined included perceived stress (six studies), depression (two studies), anxiety (two studies), negative affect (two studies), sleep quality (three studies), and nervousness (one study). The durations of the interventions ranged from 28 days to six months. Follow-up assessments took place immediately after the interventions in all eight studies, with one study also conducting a follow-up 18 months later. All eight studies reported attrition rates immediately following the intervention. In studies with three or four arms, the primary group for the DHT-based exercise intervention was designated as the intervention group (Table 1). The attrition rates immediately post-intervention ranged from 0.0% to 34.6% for the intervention groups and from 1.7% to 34.6% for the control groups. The weighted average attrition rates were 16.8% for the intervention group and 12.4% for the control group. Two studies reported on adherence: in a yoga intervention, all participants attended the minimum recommended number of sessions, with an average attendance of 16.6 sessions. In an aerobic physical exercise intervention, nine out of 30 participants in the intervention group did not complete 70% of the sessions. Among the three studies that quantitatively measured physical activity outcomes, two reported significant improvement in physical activity levels or reduction of sedentary time. The other studies provided only qualitative findings.
Participant flow
1) Identified records: database (n=37851)
Records excluded before the screening:
Records marked as ineligible
marked as ineligible by automated tools (n=515)
Records excluded for other reasons (limited to 2010 and later) (n=3275)
2) Screened records (n=19091)
Of which, reports removed (n=18806)
3) Reports sought to obtain (n=285)
Of which, reports removed (n=140)
4) Total studies adopted for review (n=145)
Adverse events
Outcome measures
mental health symptoms (e.g., depression, anxiety, negative affect, perceived stress, traumatic stress reactions, and sleep quality)
attrition and adherence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As this study is a systematic review, ethical approval is not required. However, this form cannot be submitted without entering an "Ethics Committee Approval Date," so June 30, 2025 was provisionally entered.
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058916
