Clinical trial NCT06207526: Delusion Ideation in the Context of Everyday Life
Official title: Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorder
Keywords: psychotic disorders
psychotherapy
EMA
EMI
delusions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutscher Akademischer Austausch Dienst
name: Swinburne University of Technology
First posted: 2024-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm-feasibility-design is used. All participants will receive the intervention immediately after the baseline assessment (T0). All participants are allowed to continue standard scheduled treatment.
Primary purpose: TREATMENT

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 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.

Eligibility 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)

Primary outcomes:
measure: Feasibility and acceptability of the intervention
timeFrame: Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Acceptability of the intervention
timeFrame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Side effects
timeFrame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary outcomes:
measure: Objective intensity of delusions
timeFrame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Subjective intensity of delusions
timeFrame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Psychological distress
timeFrame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Stress, anxiety and depression
timeFrame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: self-assessed recovery
timeFrame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Delusional ideation
timeFrame: At baseline, during EMA and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
measure: Adverse events
timeFrame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Study officials:
References: