Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)
Cognitive Behavior Therapy + Ecological Momentary Assessment
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)
Cognitive Behavior Therapy + Ecological Momentary Assessment
干预措施: Ecological Momentary Assessment (EMA) (Other)
Treatment as Usual (TAU)
Cognitive Behavioural Therapy (Treatment as Usual)
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 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.
次要结局
- 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)
- Personality Inventory for DSM-5 - Brief Form Plus (PID-5-BF+ M)(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)
- Treatment Satisfaction Questionnaire (ZUF-8)(Immediately after the last session)
- 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)
- Evaluation of Treatment Progress Questionnaire (FEP-2)(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)(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)(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)(Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up)
- 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)
- Level of Personality Functioning Scale - Brief Form (LPFS-BF 2.0)(Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up)
研究者
Birgit Watzke
Full Professor
University of Zurich