Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207526
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-19
Brief Title:
Delusion Ideation in the Context of Everyday Life
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Delusion Ideation in the Context of Everyday Life a Novel Smartphone-supported Psychological Therapy Approach DICE
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DICE
Brief 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 als 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 participants 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
The intervention begins with a session of psychoeducation assessment and training followed by a week of EMA monitoring using the participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None