Delusion Ideation in the Context of Everyday Life

Last updated: January 4, 2024
Sponsor: Charite University, Berlin, Germany
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

Blended face-to-face and smartphone intervention

Clinical Study ID

NCT06207526
DICE2023
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. be between 18 and 65 years old
  2. fulfill the diagnostic criteria for schizophrenia as determined by theMini-International Neuropsychiatric Interview (M.I.N.I.) (Sheehan et al., 1998)
  3. suffer from residual delusions and significant self-reported distress as assessed bythe PSYRATS Delusions (Haddock et al., 1999), Green Paranoid Thoughts, and SubjectiveExperiences 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 otherpsychopharmacological 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 ratingappointments

Exclusion

Exclusion Criteria: 8. Severe visual impairment 9. Acute suicidal tendencies 10. Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green ParanoidThoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Blended face-to-face and smartphone intervention
Phase:
Study Start date:
April 06, 2023
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 1220
    Germany

    Active - Recruiting

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