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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy (CBT)
* Other: Ecological Momentary Assessment (EMA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)<br>Cognitive Behavior Therapy + Ecological Momentary Assessment | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 20 sessions of face-to-face, individual CBT<br>Other: Ecological Momentary Assessment (EMA)<br>* Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes<br>|
| Active Comparator: Treatment as Usual (TAU)<br>Cognitive Behavioural Therapy (Treatment as Usual) | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 20 sessions of face-to-face, individual CBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Psychotherapy, Monitoring, Randomised Controlled Trial