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| Name | Class |
|---|---|
| Universität Tübingen | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA) | Experimental | Cognitive Behavior Therapy + Ecological Momentary Assessment |
|
| Treatment as Usual (TAU) | Active Comparator | Cognitive Behavioural Therapy (Treatment as Usual) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Behavioral | 20 sessions of face-to-face, individual CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Birgit Watzke, PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychotherapeutisches Zentrum Universität Zürich | Recruiting | Zurich | Canton of Zurich | 8032 | Switzerland |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000072860 | Ecological Momentary Assessment |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011581 | Psychological Tests |
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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.
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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.
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| Ecological Momentary Assessment (EMA) | Other | Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Immediately after the last session |