Delusion Ideation in the Context of Everyday Life (DICE)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Psychotic Disorder

Treatments: Behavioral: Blended face-to-face and smartphone intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06207526

DICE2023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Blended face-to-face and smartphone intervention for delusional thoughts and experiences

Experimental group

Description:

The blended face-to-face and smartphone intervention is implemented as a four-session intervention that is primarily based on an intervention from Bell et al. (2018/2020) which focused on hallucinations and is now being tailored to delusions. The intervention itself builds on the "Coping Strategy Enhancement" - program by Tarrier and colleagues (CSE; (Tarrier et al., 1990) by systematically build upon already applied coping strategies and therefore improve coping with psychotic symptoms. Participants receive four therapy sessions in person, while the app is used to collect data between sessions to be used in therapy and to record and train coping strategies between sessions. All participants are allowed to continue parallel implemented standard scheduled treatment.

Treatment:

Behavioral: Blended face-to-face and smartphone intervention