DepressionISA-BellNCT05553197
Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
A study testing Cognitive Behavioural Therapy (CBT) and Ecological Momentary Assessment (EMA) in people with Depression, run by Birgit Watzke at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioural Therapy (CBT) and Ecological Momentary Assessment (EMA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Psychotherapeutisches Zentrum Universität Zürich
Zurich, Canton of Zurich, 8032
Louisa Jagmetti, M.Sc., +41 44 635 73 28, louisa.jagmetti@psychologie.uzh.ch
Fiona Fäh, +41 44 635 73 21, fiona.faeh@psychologie.uzh.ch
About this study
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.
Read the 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).
- Conditions
- Depression
- Being tested
- Cognitive Behavioural Therapy (CBT), Ecological Momentary Assessment (EMA)
- Keywords
- Depression, Psychotherapy, Monitoring, Randomised Controlled Trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
20 sessions of face-to-face, individual CBT
Ecological Momentary Assessment (EMA)Other
Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA) | Experimental | Cognitive Behavior Therapy + Ecological Momentary Assessment Receives: Behavioral: Cognitive Behavioural Therapy (CBT); Other: Ecological Momentary Assessment (EMA) |
| Treatment as Usual (TAU) | Active comparator | Cognitive Behavioural Therapy (Treatment as Usual) Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-month follow-up
Secondary outcomes (12)
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.
Measured: 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)
Participant-reported measure assessing changes in depressive symptoms. The total score of this twenty-one-item scale ranges from 0-63, with higher scores indicating greater depression severity.
Measured: 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)
Participant-reported measure assessing mentalisation of oneself and others. The total score of this forty-item scale ranges from 40-280, with higher scores indicating a greater frequency of successful mentalisation.
Measured: 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)
Participant-reported measure assessing dysfunctional attitudes. The total score of this eighteen-item scale ranges from 18-126, with higher scores indicating greater levels of dysfunctional attitudes.
Measured: 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)
Participant-reported measure assessing depression-specific self-efficacy. The total score of this five-item scale ranges from 0-25, with higher scores indicating greater levels of depression-specific self-efficacy.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Evaluation of Treatment Progress Questionnaire (FEP-2)
Participant-reported measure assessing subjective treatment progress. The total score of this forty-item scale ranges from 40-200, with higher scores indicating poorer treatment outcome.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Level of Personality Functioning Scale - Brief Form (LPFS-BF 2.0)
Participant-reported measure assessing the level of personality functioning. The total score of this twelve-item scale ranges from 12-48, with higher scores indicating lower levels of functioning.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Positive and Negative Affect Schedule (PANAS)
Participant-reported measure assessing positive and negative affect using two subscales. The total score of each 10-item-subscale ranges from 10-50 with higher scores indicating greater levels of positive or negative affect in the corresponding subscales.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Personality Inventory for DSM-5 - Brief Form Plus (PID-5-BF+ M)
Participant-reported measure assessing personality traits. The total score of this thirty-six-item scale ranges from 0-108, with higher scores indicating greater personality pathology.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Health Survey - Short Form (SF-8)
Participant-reported measure assessing changes in health-related quality of life.The total score of this eight-item scale ranges from 8-42, with higher scores indicating poorer health-related quality of life.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Symptoms Checklist (SCL-K-9)
Participant-reported measure assessing symptoms during psychotherapy. The total score of this nine-item scale ranges from 0-36, with higher scores indicating greater symptom severity.
Measured: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Treatment Satisfaction Questionnaire (ZUF-8)
Participant-reported measure assessing patients' satisfaction with treatment. The total score of this eight-item scale ranges from 8-32, with higher scores indicating greater treatment satisfaction.
Measured: Immediately after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Nov 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birgit Watzke
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor-investigator, Birgit Watzke, University of Zurich
- Investigators
- Birgit Watzke, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553197
- Sponsor's protocol ID
- 10001C_200760
- Acronym
- ISA-Bell
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
- ClinicalTrials.gov ID
- NCT05553197
- Acronym / sponsor ID
- ISA-Bell / 10001C_200760
- Conditions
- Depression
- Keywords
- Depression, Psychotherapy, Monitoring, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Birgit WatzkeUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA) | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT), Other: Ecological Momentary Assessment (EMA)Cognitive Behavior Therapy + Ecological Momentary Assessment |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT)Cognitive Behavioural Therapy (Treatment as Usual) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy (CBT)20 sessions of face-to-face, individual CBT | Behavioural | Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA), Treatment as Usual (TAU) |
| Ecological Momentary Assessment (EMA)Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes | Other | Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA) |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 4-month follow-up
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.
12 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Evaluation of Treatment Progress Questionnaire (FEP-2)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Level of Personality Functioning Scale - Brief Form (LPFS-BF 2.0)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Personality Inventory for DSM-5 - Brief Form Plus (PID-5-BF+ M)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Health Survey - Short Form (SF-8)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Symptoms Checklist (SCL-K-9)
Time frame: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up
Treatment Satisfaction Questionnaire (ZUF-8)
Time frame: Immediately after the last session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgit Watzke, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) and Ecological Momentary Assessment (EMA) in people with Depression, run by Birgit Watzke at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louisa Jagmetti, M.Sc. (+41 44 635 73 28, louisa.jagmetti@psychologie.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: 4-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.