Delusion Ideation in the Context of Everyday Life (NCT06207526) | Clinical Trial Compass
UnknownNot Applicable
Delusion Ideation in the Context of Everyday Life
Germany15 participantsStarted 2023-04-06
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Severe visual impairment
✕. Acute suicidal tendencies
What they're measuring
1
Feasibility and acceptability of the intervention
Timeframe: Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
2
Acceptability of the intervention
Timeframe: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
3
Side effects
Timeframe: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
0. Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green Paranoid Thoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)