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Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)

The effects of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression are assessed in this randomised trial. Monitoring consists of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA are compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). 84 patients with mild to moderate depression will be randomised to CBT + EMA or to TAU.

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ClinicalTrials.gov IDNCT05553197

PhaseNA

Enrollment84

SponsorBirgit Watzke

Age18 Years and older

SexALL

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Conditions studied

Depression

About this study

Interventions

Behavioral: Cognitive Behavioural Therapy (CBT) — 20 sessions of face-to-face, individual CBT
Other: Ecological Momentary Assessment (EMA) — Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes

Primary outcomes

Patient Health Questionnaire (PHQ-9) (4-month follow-up)

Eligibility information

Inclusion Criteria: * ICD-10 diagnosis of mild or moderate depression, first or recurrent episode (F32.0, F32.1, F33.0, F33.1) * PHQ-9 ≥ 5 * Possession of smartphone with internet access * Signed informed consent Exclusion Criteria: * Acute or past suicidality; self-reported * Acute addiction (F10 - F19) * Dysthymia (F34.1), postpartum depression, or severe depression (F32.3; F33.3) * PHQ-9 \> 20 * Depression not main mental health concern * Planned onset or planned change in antidepressant medication * History of psychotic symptoms, bipolar disorder, personality disorders, or organic brain disorders * Cognitive impairment or physical disability that would hinder psychotherapy or the use of a smartphone

Study locations

Psychotherapeutisches Zentrum Universität Zürich, Zurich, Canton of Zurich 8032 Switzerland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-15.