The missing link between daily life and the therapist's office.

Rationale: Major depressive disorder (MDD) is a disabling condition with debilitating consequences for those who suffer from it and their relatives. Optimizing treatments will reduce societal burden and risk for relapse, and improve an individual’s quality of life. A pioneer Randomized Controlled Trial (RCT) has shown that systematic intensive self-monitoring and personalized feedback on contextualized patterns of positive affect through Ecological Momentary Assessment (EMA) could provide an effective add-on tool to routine clinical care for depression. While promising, standardized EMA and feedback modules were used, and the study focused only on positive affect, in a relatively less affected group of patients in secondary care. In this project, we will use a personalized EMA and feedback module, named Therap-i, to intensively self-monitor affect and person specific factors in daily life in patients with MDD in tertiary care. We hypothesize that this module will contribute to decreased depressive symptoms via a more precise descriptive diagnosis, tailored treatment and increased self-insight, resulting in enduring increased self-management and better functional outcomes.

Objective: The main aim is to investigate the efficacy of the Therap-i module, as an add-on to treatment-as-usual (TAU), for decreasing depressive symptoms in complex patients with MDD.

Study design: A RCT with two treatment arms: TAU and TAU + Therap-i module. TAU consists of policlinic psychological treatment for patients with MDD. The Therap-i module can be added to TAU. Randomization (allocation ratio 1:1) will be stratified on the predicted treatment resistance based on the Dutch Method for Quantification of Treatment Resistance in Depression (DM-TRD, Peeters et al., 2016).

Study population: We aim to recruit 100 (TAU, n=50; TAU + Therap-i module, n=50) patients with MDD aged between 18-65 years, receiving policlinic psychological treatment.

Intervention (if applicable): In the Therap-i module participants will systematically self-monitor their affect and person-specific factors five times a day for two months with an electronic diary. The diary items are based on participants’ patient data and case-conceptualization (CC), and discussed by the therapist, researcher and participant to reach a definitive selection. After 2, 4 and 8 weeks of EMA monitoring, participants will receive a personalized feedback report, which will be discussed by the therapist, researcher and participant.
Main study parameters/endpoints: The primary outcome measures to determine efficacy of the intervention will be the change in depressive symptom severity, as measured by the Inventory of Depressive Symptomatology self-report (IDS-SR). Secondary outcome measures to determine efficacy of the Therap-i module are changes in i) psychological functioning as measured by the Outcome Questionnaire (OQ-45), ii) illness perception as measured by the Illness Perception Questionnaire Mental Health (IPQ-MH), iii) therapeutic alliance as measured by the Work Alliance Inventory – Short Form Revised (WAI-SR). A descriptive outcome measure to determine efficacy of the Therap-i module are differences between the treatment arms in self-management as measured by the Questionnaire of Self-Management in the Recovery from Depression (QSRD).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks involved in study participation. The burden associated with participation consists of: Taking part in an instruction session, a resilience interview, and an electronic diary creation session during a regular consult; filling out baseline questionnaires and wearing a motion watch for two months (experimental group; EG), and (EG and control group; CG; 2 hours 45 minutes); filling out an electronic diary on a smartphone five times a day for two months (2 minutes per measurement) during TAU (EG); taking part in three feedback sessions wherein the personal feedback report will be discussed during a regular consult (EG; 45 minutes per session), and filling out questionnaires (EG and CG; 18 minutes); filling out evaluation questionnaires and participating in a semi-structured interview (n=20) at the end of the Therap-i module (EG; 30 minutes); taking part in 4 follow-up questionnaire assessments after 1, 2, 3 and 6 months (EG and CG; 18 minutes per assessment). Benefits are increased insight in (fluctuations in) one’s own affect and person specific factors that may decrease depressive symptoms by increasing self-management and improving functional outcomes.

In this project, a personalized EMA and feedback module, named Therap-i, is added to the treatment-as-usual (TAU) in patients with a depression diagnosis in tertiary care. The module is used to systematically self-monitor and reflect on momentary affect and person specific factors in daily life, and is expected to contribute to a more precise diagnosis facilitating personal tailored treatment.

The main hypothesis is that compared to TAU, the module is more effective in decreasing depressive symptoms. Secondary, we expect that compared to TAU, the module increase self-insight, resulting in enduring increased self-management and better functional outcomes.

(time in weeks)



Depressive symptom severity – Inventory of Depressive Symptomatology, self-report (IDS-SR; time points: 0, 2, 4, 6, 8, 12, 16, 20, 32)



Psychosocial functioning – Outcome Questionnaire-45 (OQ-45; time points: 0, 2, 4, 8, 12, 16, 20, 32)



Therapeutic alliance – Working Alliance Inventory, short form (WAI-SR; time points: 2, 4, 8, 12, 16, 20, 32)



Illness perception – Illness Perception Questionnaire, Mental Health (IPQ-MH; included sub-scales: personal control, treatment control, coherence, emotional representation; time points: 0, 2, 4, 8, 12, 16, 20, 32)



Self-management – Questionnaire of Self-management in the Recovery from Depression (QSRD; time points: 12)

Treatment as usual + Therap-i