Delusion Ideation in the Context of Everyday Life

Psychotic Disorder Clinical Trial

— DICE  

Official title:

Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207526
• Other study ID #: DICE2023
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Charite University, Berlin, Germany
• Contact: Kerem Böge, PD Dr. Dr.
• Phone: (+49)30 - 450 517636
• Email: kerem.boege[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delusions
• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders

Intervention

Behavioral:
• Blended face-to-face and smartphone intervention
The intervention comprises two phases: an initial stage involves baseline assessment, in-depth app training, psychoeducation, and EMA monitoring for functional analysis. The subsequent phase focuses on identifying and implementing individual coping strategies, forming the basis for daily personalized EMI reminders. Over six days, participants receive ten daily surveys to gauge fluctuations in paranoia and delusional ideation. EMA-derived feedback, considering antecedents and coping responses, shapes a personalized EMI. Four sessions with a psychologist involve discussing app feedback, emphasizing functional analysis, coding coping strategies into the app, assessing utility, and adapting as needed. Post-session two, five coping reminders and an eight-item evening survey are sent daily for two blocks of ten days to monitor delusional ideations and coping strategy effectiveness.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutscher Akademischer Austausch Dienst, Swinburne University of Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the intervention	Feasibility will be indexed by completion rates of the EMA questionnaires (minimum threshold of >33% of completed EMA questionnaires), by whether participants use the application between sessions (>80% of clients) and whether the target level of ecological momentary assessment data for analysis is recorded (>80% of clients).	Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Primary	Acceptability of the intervention	Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982) and a series of open-ended questions about elements of the intervention, in addition to the rate of intervention completion (>80% complete all sessions).	Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Primary	Side effects	Negative effects will be recorded by using the Negative Incidents and Effects Questionnaire (Rozental et al., 2019).	Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Objective intensity of delusions	The psychotic symptom rating scales, PSYRATS (Haddock et al., 1999), measures the severity of different dimensions of auditory hallucinations and delusions, designed as semi-structured interviews. We will be using the delusions scale	At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Subjective intensity of delusions	The Green Paranoid Thought Scale in its revised form, R-GTPS (Freeman et al., 2021), will be used to record the subjective intensity of delusions. The measuring instrument consists of two separate subscales, with eight items assessing ideas of reference and ten items assessing ideas of persecution.	At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Psychological distress	The Subjective Experiences of Psychosis Scale, SEPS (Haddock et al., 2011), will be used to assess the psychological distress associated with experiencing delusions, as it is a measurement to assess an index of psychosis-related impact. The SEPS is a 41 item self-report scale assessing experiences of psychosis in terms of three subscales.	At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Stress, anxiety and depression	The Depression Anxiety Stress Scale (Nilges & Essau, 2015) will be used to analyse symptoms of stress, anxiety and depression.	At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	self-assessed recovery	The Questionnaire about the Process of Recovery (Neil et al., 2009) will be used as a measure of self-assessed recovery of mental health.	Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Delusional ideation	The 21-item Peters et al. (2004) Delusions Inventory (PDI) is being used to measure the delusional ideation. The PDI incorporates the multidimensionality of delusions by including measures of distress, preoccupation, and conviction. Participants have to rate their predominant pdi-item troughout the EMA.	At baseline, during EMA and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary	Adverse events	The Negative Incidents and Effects Questionnaire (NIEQ) (Rozental et al., 2019) will be used to register adverse events.	Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)