NCT06207526

Delusion Ideation in the Context of Everyday Life

Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Psychotic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Blended face-to-face and smartphone intervention	The intervention comprises two phases: an initial stage involves baseline assessment, in-depth app training, psychoeducation, and EMA monitoring for functional analysis. The subsequent phase focuses on identifying and implementing individual coping strategies, forming the basis for daily personalized EMI reminders. Over six days, participants receive ten daily surveys to gauge fluctuations in paranoia and delusional ideation. EMA-derived feedback, considering antecedents and coping responses, shapes a personalized EMI. Four sessions with a psychologist involve discussing app feedback, emphasizing functional analysis, coding coping strategies into the app, assessing utility, and adapting as needed. Post-session two, five coping reminders and an eight-item evening survey are sent daily for two blocks of ten days to monitor delusional ideations and coping strategy effectiveness.

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-03-31
• Completion: 2024-08-31
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: Germany