Study of a smartphone-delivered, therapist-supported mindfulness-based therapy program for depression in Finnish university students

INTERVENTION: This is a randomized controlled study testing the efficacy of the Ascend program for depression. The program is delivered through a smartphone application, and guided by a therapist. Approximately 120 patients with depression from Finnish Student Health Service (YTHS) are recruited and divided according to the use of antidepressant medication, and then randomized to: 1. The intervention group receiving the Ascend therapy program and treatment as usual (TAU + therapy program arm) 2. The control group receiving only the treatment as usual (TAU arm) Within both groups, stratification, i.e. random division into two equal‐size subgroups, is conducted based on antidepressant medication use. Randomization is done by the Clinpal‐platform, and the trialists are unaware of the details (on purpose). Also the above mentioned random stratification is conducted by the Clinpal. Only participants in the intervention group receive intensive 8‐week Ascend therapy program during the study. Those in the control group have the possibility to attend the 8‐week Ascend therapy program free of charge once the study is completed. Total duration of the whole study for both intervention group and control group is 8 months. The duration of the intervention is 2 months and the follow‐up after the intervention is 6 months. Those in the control group are followed (simultaneously) for the whole 8 months. They are entitled to attend the therapy program after the follow‐up is completed if they wish so. The Ascend therapy program is an online mindfulness‐ and cognitive behavioral therapy ‐based intervention that lasts 8 weeks and is delivered via a smartphone application provided by Meru Health Inc. The therapy program is approved by a Finnish healthcare official (Valvira approval, dnro V/25535/2017). It requires on average of 10‐40 minutes of daily practice, six days a week, in addition to the time spent communicating with the therapist and the group via program chat. All information and int CONDITION: Acute depressive disorder (ICD‐10 codes F32.0, F32.1, F32.2, and F33.0, F33.1, F33.2, F33.4, F33.8, F33.9) ; Mental and Behavioural Disorders ; Depression PRIMARY OUTCOME: Depressive symptoms, measured using the Patient Health Questionnaire 9 (PHQ‐9) at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; INCLUSION CRITERIA: 1. Diagnosis of a depressive disorder (ICD‐10 F32 or F33) at the time of enrollment 2. Willingness to commit to the 8‐week online therapy program 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 SECONDARY OUTCOME: 1. Anxiety symptoms, measured using Generalized Anxiety Disorder 7 (GAD‐7) at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 2. Sleep problems, measured using the Insomnia Severity Index (ISI) at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 3. Quality of life, measured using EUROHIS‐Qol 8‐item index at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 4. Internalization of mindfulness skills, measured using Five Facet Mindfulness Questionnaire ‐ Short Form, FFMQ‐SF at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 5. Experienced stress symptoms, measured using Perceived Stress Scale (PSS) at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 6. Resilience, measured using Resilience Scale at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months post‐intervention; 7. User‐friendliness of the mobile phone (online therapy program) application, measured using System Usability Scale at 8 weeks