Clinical trial NCT05553197: Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
Official title: Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Psychotherapy
Monitoring
Randomised Controlled Trial
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2022-09-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4/7 of participants will be randomised to CBT + EMA and 3/7 to TAU. This randomisation ratio is chosen to foster longitudinal analyses in the CBT + EMA group. Randomisation is stratified by pre-treatment severity of depressive symptoms. Participants with PHQ-9 scores 5-9 will be randomised separately from participants with PHQ-9 scores 10-20.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: As mobile technologies advance, healthcare is increasingly utilising mobile interventions to accompany traditional interventions such as psychotherapy. Mobile assessments of symptoms and other processes are also used as low-level interventions and are believed to lead to symptom improvements in patients with symptoms of depression, for example. However, robust evidence on the health benefits of monitoring interventions in patients with depression is lacking.

The investigators are interested in the potential benefits of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression. Therefore, the investigators will conduct a randomised trial to investigate the effects of a monitoring intervention consisting of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA will be compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). Participants in the CBT + EMA group will be asked to answer monitoring questions twice daily for two four-week blocks during the CBT treatment. A total of 84 participants with mild to moderate depression will be randomized. Of these, 48 participants will be randomized to CBT + EMA and 36 participants will be randomized to TAU. The primary outcome of interest is change in the Patient Health Questionnaire (PHQ-9) score at four-month follow-up assessment.

Throughout the study, there will be five assessment timepoints: Baseline (before the first therapy session), four weeks after the fourth therapy session, four weeks after the twelfth therapy session, after the last session (post-treatment) and the 4-month follow-up (four months after the last therapy session).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4-month follow-up
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Beck's Depression Inventory (BDI-II)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Certainty About Mental States Questionnaire (CAMSQ)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Dysfunctional Attitude Scale (DAS-18A)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Depression-Specific Self-Efficacy Expectation Questionnaire (DSWE)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Evaluation of Treatment Progress Questionnaire (FEP-2)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Level of Personality Functioning Scale - Brief Form (LPFS-BF 2.0)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Personality Inventory for DSM-5 - Brief Form Plus (PID-5-BF+ M)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Health Survey - Short Form (SF-8)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Symptoms Checklist (SCL-K-9)
timeFrame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
measure: Treatment Satisfaction Questionnaire (ZUF-8)
timeFrame: Immediately after the last session
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychotherapeutisches Zentrum Universität Zürich
state: Kanton Zürich
Study officials:
affiliation: University of Zurich
name: Birgit Watzke, PhD
role: PRINCIPAL_INVESTIGATOR
References: