Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability of the intervention
研究概览
简要总结
The project aims to investigate the feasibility and acceptability of a blended face-to-face and smartphone intervention for distressing thoughts and experiences in people with schizophrenia spectrum disorders. A secondary aim is to assess the outcomes of the intervention at baseline (T0) and post-intervention (T1) (single-arm feasibility design). The study design is primarily based on Bell et al.'s (2018, 2020) blended face-to-face and smartphone intervention for hallucinations. The participants receive four face-to-face therapy sessions, using a smartphone between sessions employing elements of Ecological Momentary Assessment (EMA) and Intervention (EMI).
详细描述
The investigators will identify eligible participants at different outpatient departments, suitable support groups, and online platforms. An eligibility screening conducted in person or by telephone to ensure the inclusion criteria and to introduce the study is held by the study assistant. All participants must sign an informed consent after written and verbal study clarification. Participants will carry out self-reported measurements at baseline (T0) and after the intervention phase of 4-6 weeks (T1). The group of participants receives four therapy sessions, using a smartphone between sessions.
The intervention begins with a session of psychoeducation, assessment and training, followed by a week of EMA monitoring using the participant's own smartphone or one provided by the research team. In the second session, EMA data will be discussed between therapist and participants to identify patterns in experiences, including effective and ineffective coping strategies. In the weeks between the remaining sessions, participants are reminded of these strategies via the app using EMI.
The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. Besides, the participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between 18 and 65 years old
- •fulfill the diagnostic criteria for schizophrenia as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) (Sheehan et al., 1998)
- •suffer from residual delusions and significant self-reported distress as assessed by the PSYRATS Delusions (Haddock et al., 1999), Green Paranoid Thoughts, and Subjective Experiences of Psychosis Scales (Freeman et al., 2021).
- •sufficient knowledge of German
- •have not undergone a recent (<6 weeks) or planned change in antipsychotic and other psychopharmacological medication
- •know how to use a smartphone or be willing to learn how to use it
- •Time availability to attend 4 therapy appointments with two additional rating appointments
排除标准
- •Severe visual impairment
- •Acute suicidal tendencies
- •Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green Paranoid Thoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)
结局指标
主要结局
Feasibility and acceptability of the intervention
时间窗: Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Feasibility will be indexed by completion rates of the EMA questionnaires (minimum threshold of \>33% of completed EMA questionnaires), by whether participants use the application between sessions (\>80% of clients) and whether the target level of ecological momentary assessment data for analysis is recorded (\>80% of clients).
Side effects
时间窗: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Negative effects will be recorded by using the Negative Incidents and Effects Questionnaire (Rozental et al., 2019).
Acceptability of the intervention
时间窗: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson \& Zwick, 1982) and a series of open-ended questions about elements of the intervention, in addition to the rate of intervention completion (\>80% complete all sessions).
次要结局
- Adverse events(Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- Subjective intensity of delusions(At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- Objective intensity of delusions(At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- Psychological distress(At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- self-assessed recovery(Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- Stress, anxiety and depression(At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
- Delusional ideation(At baseline, during EMA and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline))
研究者
Kerem Böge
PD Dr. Dr.
Charite University, Berlin, Germany