Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
Recruiting · NCT05553197 · Interventional (participants receive a specific treatment) · Lead sponsor: Birgit Watzke
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive Behavioural Therapy (CBT)Ecological Momentary Assessment (EMA)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Psychotherapeutisches Zentrum Universität Zürich - Zurich, Canton of Zurich, Switzerland