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

NCT05553197 | Recruiting

• 1 other identifier: 10001C_200760
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Psychotherapy; Monitoring; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  Participant-reported measure assessing depressive symptomatology. The total score of this nine-item scale ranges from 0-27, with higher scores indicating greater depression-symptom severity.

  4-month follow-up

Secondary Outcomes (12)

• Patient Health Questionnaire (PHQ-9)

  Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up

• Beck's Depression Inventory (BDI-II)

  Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up

• Certainty About Mental States Questionnaire (CAMSQ)

  Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up

• Dysfunctional Attitude Scale (DAS-18A)

  Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up

• Depression-Specific Self-Efficacy Expectation Questionnaire (DSWE)

  Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up

Study Arms (2)

Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)

EXPERIMENTAL

Cognitive Behavior Therapy + Ecological Momentary Assessment

Behavioral: Cognitive Behavioural Therapy (CBT); Other: Ecological Momentary Assessment (EMA)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Cognitive Behavioural Therapy (Treatment as Usual)

Behavioral: Cognitive Behavioural Therapy (CBT)

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

20 sessions of face-to-face, individual CBT

Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA); Treatment as Usual (TAU)

Ecological Momentary Assessment (EMA) OTHER

Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes

Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birgit Watzke: lead
• Universität Tübingen: collaborator

Study Sites (1)

Psychotherapeutisches Zentrum Universität Zürich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy; Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Psychological Tests

Study Officials

• Birgit Watzke, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louisa Jagmetti, M.Sc.

CONTACT

+41 44 635 73 28; louisa.jagmetti@psychologie.uzh.ch

Fiona Fäh

CONTACT

+41 44 635 73 21; fiona.faeh@psychologie.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As is common in psychotherapy research, participants and care providers cannot be blinded to the intervention. Only subjective outcomes (i.e., participant-rated) are assessed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 23, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)