| Methods |
Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): not specified in trial registration
Imputation of missing data: not specified |
| Participants |
Country: Finland
Setting: smartphone‐delivered intervention
Age: range = 18 ‐ 40 years (see inclusion criteria)
Sample size (randomised): 120 targeted
Sex: not specified
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified
Population description: Finnish university students with diagnosed depression
Method of recruitment: recruited through the Finnish Student Health Service’s centres in 4 Finnish cities; Tampere, Turku, Jyväskylä and Helsinki; patients with depression from Finnish Student Health Service (YTHS)
Inclusion criteria: 1) diagnosis of a depressive disorder (ICD‐10 (International Classification of Diseases‐10): diagnoses F32 or F33) at the time of enrolment; 2) willingness to commit to the 8‐week online therapy programme; 3) no prior established mindfulness practice/meditation experience; 4) aged 18 ‐ 40 years; 5) living in Finland; 6) has a smartphone with iOS or Android mobile operating system; 7) access to mobile internet
Exclusion criteria: 1) previous suicide attempts; 2) severe suicidal ideation; 3) other serious mental disorders such as psychosis or severe personality disorders; 4) active substance abuse; 5) ongoing psychotherapy
Attrition (withdrawals and exclusions): not specified in trial registration
Reasons for missing data: not specified in trial registration |
| Interventions |
Intervention: TAU (regular treatment for depression) + Ascend therapy programme (n = 60 planned)
delivery: delivered by smartphone application provided by Meru Health Inc. (participants do not meet each other physically, but form an online peer‐group within the application); combined setting (communication with therapist + communication with group by programme chat; group of 8 ‐ 15 individuals for 8‐week course); all information and introductions to practices are given inside the application providers: guided by therapist; healthcare professionals with training in MBSR/MBCT and with cognitive behavioural therapy skills duration of treatment period and timing: 8 weeks; average of 10 ‐ 40 minutes of daily practice, 6 days a week -
description:
educational material on depression and related symptoms (texts, videos, audios) audio‐guided mindfulness practices (e.g. sitting, walking, body scanning) cognitive behavioural therapy (CBT)‐styled thought reflection (e.g. thought diary) phone calls with a therapist (default: baseline, and more often only if needed) chat with a therapist (therapist’s response to participant is guaranteed within 24 hours): there are no requirements for the amount (minimum or maximum) of chatting peer‐group: programme participants constitute an anonymous peer‐group of 8 ‐ 15 individuals that undergo the programme simultaneously; participants are able to see each other’s chat messages with the therapist (group chat), but they are not able to comment on each other’s messages. Also, there is a private chat option with the therapist, and participants choose themselves whether they wish to use private chat or group chat. All participants receive oral and written directive for the potential abrupt depressive symptom worsening, where contacting physician/going to the emergency is recommended, along with contacting one’s own Ascend programme therapist
compliance: not specified integrity of delivery: not specified economic information (intervention cost, changes in other costs as result of intervention): not specified theoretical basis: mindfulness‐ and CBT‐based
Control: TAU (n = 60 planned)
delivery: not specified providers: delivered by Finnish Student Health Service duration of treatment period and timing: frequency of the appointments is modified according to patients’ individual needs -
description:
TAU may include appointments with nurses, psychologists and/or physicians, laboratory tests, and it may or may not include antidepressant medication TAU does not involve any psychotherapy possibility of attending Ascend therapy programme free of charge once study is completed
compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: not specified
|
| Outcomes |
Outcomes collected and reported:
Primary outcome:
Secondary outcomes:
anxiety symptoms ‐ GAD7 sleep problems ‐ ISI quality of life ‐ EUROHIS‐Qol 8‐item index internalization of mindfulness skills ‐ FFMQ ‐ Short Form experienced stress symptoms ‐ PSS resilience ‐ RS user‐friendliness of mobile phone (online therapy programme) application ‐ System Usability Scale
Outcomes reported not specified
Time points measured and reported: 1) pre‐intervention; 2) 2 weeks; 3) 4 weeks 4) 6 weeks; 5) 8 weeks; 6) 3 months; 7) 6 months post‐intervention; user‐friendliness of mobile phone application only measured at 8 weeks; time points reported not specified
Adverse events: not specified |
| Notes |
Contact with authors: We contacted the authors to ask if the trial also included healthcare students, but received no response
Study start/end date: 1 April 2018 ‐ 31 December 2019
Funding source: Meru Health Inc.; Lifeline Ventures Inc.
Declaration of interest: not specified
Ethical approval needed/obtained for study: Ethics Committee of the Tampere University Central Hospital
Comments by study authors: not relevant
Miscellaneous outcomes by the review authors: recruitment status: not longer recruiting; overall trial status: completed (last updated: September 2019); unclear if healthcare students included in final sample
Correspondence: Dr Anu Raevuori; Meru Health; Lapinlahdenkatu 16, Helsinki 00180, Finland |
