Blended face-to-face and smartphone intervention for distressing thoughts in schizophrenia
Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)
This study is testing a new way to help people with schizophrenia manage distressing thoughts by combining in-person therapy sessions with support from a smartphone app.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06207526 on ClinicalTrials.gov |
What this trial studies
This project investigates the feasibility and acceptability of a combined face-to-face and smartphone intervention aimed at addressing distressing thoughts and experiences in individuals with schizophrenia spectrum disorders. Participants will engage in four therapy sessions complemented by smartphone-based monitoring and interventions over a 4-6 week period. The study employs Ecological Momentary Assessment (EMA) to track experiences and coping strategies, with data collected at baseline and post-intervention to evaluate outcomes. The intervention is designed to enhance coping mechanisms and reduce distress related to delusions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have a diagnosis of schizophrenia and experience residual delusions with significant distress.
Not a fit: Patients with severe visual impairment, acute suicidal tendencies, or excessive delusional symptoms may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the management of distressing thoughts in patients with schizophrenia, leading to better overall mental health outcomes.
How similar studies have performed: Other studies have shown promise with blended interventions for psychotic disorders, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. be between 18 and 65 years old 2. fulfill the diagnostic criteria for schizophrenia as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) (Sheehan et al., 1998) 3. 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). 4. sufficient knowledge of German 5. have not undergone a recent (\<6 weeks) or planned change in antipsychotic and other psychopharmacological medication 6. know how to use a smartphone or be willing to learn how to use it 7. Time availability to attend 4 therapy appointments with two additional rating appointments Exclusion Criteria: 8. Severe visual impairment 9. Acute suicidal tendencies 10. Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green Paranoid Thoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Kerem Böge, PD Dr. Dr.
- Email: kerem.boege@charite.de
- Phone: (+49)30 - 450 517636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.