Smartphone based Monitoring and cognition Modification Against Recurrence of Depression (SMARD) – Workpackage 1

BACKGROUND:
Despite high prevalence of MDD and 50-80% recurrence rate of Major Depressive Disorder (MDD), recurrence prevention programs for MDD have limited efficacy. This might be caused by the fact that impending recurrence is identified too late and preventive strategies do not address underlying, ethiopathophysiological risk-factors like tendency to ruminate or negative attentional biases. The Smartphone based Monitoring and cognition Modification Against Recurrence of Depression (SMARD) study will develop building blocks for a second generation recurrence prevention program, which will address earlier recognition by Smartphone application measuring individual’s behavioural changes with a background app and occasional intensive experience sampling method (ESM) data-collection with diaries.

AIMS:
The aim is to measure early changes in behavior, indicative of an imminent depressive episode by using continuous and passive monitoring of behavioral data (e.g., GPS, social media use, etc.) with the BEHAPP smartphone application (https://behapp.org/). The following objectives will be addressed:

1. Create focus-groups (≥2), which will assess the acceptability of the BEHAPP app.

2. To gather BEHAPP data and ESM data for 1.5 years in remitted patients with recurrent MDD and associate this data with follow-up data of prospective recurrences.

3. Develop an algorithm to identify recurrence.

DESIGN:
1. Focus groups to assess acceptability of BEHAPP use.
2. A prospective cohort design with a 1.5 years follow-up period.

METHODS:
Participants: Sixty Remitted participants (18 - 65 yrs.) with recurrent-MDD who are in stable remission (HDRS ≤10 for ≥8 weeks) and have vulnerability for recurrence (≥3 episodes); who are either using antidepressant maintenance therapy or not and regularly using a smartphone. Of these, 10 will participate in the initial focus-groups.

Measurements: Participants of the prospective cohort will complete a set of baseline questionnaires (IDS-SR, SHAPS, RRS-NL, LEIDS-R, DAS, APL, UCL, JTV-SR, IRS, WHOQOL, NEO-FFI, DART) and an Experience Sampling Method (ESM) period (6 days) via their smartphone, during which their positive and negative affect is assessed at 10 random multiple timepoints during the day. During a subsequent 1.5 years follow-up, participants will receive questionnaires every three months (IDS-SR, SHAPS, RRS-NL, APL, IRS, WHOQOL) and will be called every three months to assess recurrence-status of depression (using the SCID-I and HDRS). In the background behavioural data will be passively gathered using the BEHAPP smartphone application. BEHAPP is a smartphone application enabling longitudinal, 24/7 measures of an individual’s behavior (https://behapp.org/). BEHAPP passively monitors behavior ‘in the background’. A diversity of social communication and exploratory behavioral endpoint features are extracted from continuously collected smartphone sensor information such as GPS, text-messages, phone, social media (e.g., Facebook, Twitter, WhatsApp), Wi-Fi, access (social density) signals. For analyses, data will be combined with ≥50 additional subjects from SMARD WP 2.

1. A specific AI algorithm on multidimensional BEHAPP data will be able to identify a recurrence from the period preceding it (distinguishing data-patterns during remission from six weeks of a depressive episode).

2. The algorithm will be able to identify the (impending) prospective recurrence within two-weeks before it actually starts.

1. Baseline
2. Follow-up every 3 months for 1.5 years

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