Delusion Ideation in the Context of Everyday Life

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06207526
Study type	Interventional
Source	Charite University, Berlin, Germany
Contact	Kerem Böge, PD Dr. Dr.
Phone	(+49)30 - 450 517636
Email	kerem.boege@charite.de
Status	Recruiting
Phase	N/A
Start date	April 6, 2023
Completion date	August 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02306551` - Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Active, not recruiting	`NCT00627029` - Evaluation of Programs of Coordinated Care and Disease Management	N/A
Terminated	`NCT00049738` - Screening for Childhood-Onset Psychotic Disorders	N/A
Withdrawn	`NCT01724372` - The Role of Antidepressants or Antipsychotics in Preventing Psychosis	N/A
Completed	`NCT00716755` - Minimizing Doses of Antipsychotic Medication in Older Patients With Schizophrenia.	N/A
Completed	`NCT00498550` - Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual	Phase 4
Terminated	`NCT04140773` - The Effect of D-serine as add-on Therapy in Recent-onset Psychosis	N/A
Completed	`NCT01473550` - Mental Health Engagement Network (MHEN)	N/A
Completed	`NCT01207219` - Yoga and Aerobic Exercise in Psychosis	N/A
Completed	`NCT00397033` - Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.	Phase 3
Recruiting	`NCT04945278` - Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability	N/A
Completed	`NCT03955250` - Mobile After-Care Support App: Pilot RCT	N/A
Completed	`NCT00287352` - Study of Amantadine for Weight Stabilization During Olanzapine Treatment	Phase 1
Completed	`NCT00005658` - Glycine to Treat Psychotic Disorders in Children	Phase 2
Terminated	`NCT00169026` - Alcoholism and Schizophrenia: Effects of Clozapine	Phase 4
Completed	`NCT00001482` - New Drugs in the Treatment of Mood Disorders	Phase 2
Terminated	`NCT03671005` - Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders	N/A
Completed	`NCT00095524` - Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder	Phase 3
Completed	`NCT00156715` - Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder	Phase 4
Completed	`NCT03667729` - The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Delusion Ideation in the Context of Everyday Life — DICE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms