Delusion Ideation in the Context of Everyday Life (DICE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorder
• Intervention / Treatment: Behavioral: Blended face-to-face and smartphone intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerem Böge, PD Dr. Dr.; Phone Number: (+49)30 - 450 517636; Email: kerem.boege@charite.de

Study Locations

• Germany
  • Berlin, Germany, 1220
    • Recruiting
    • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
    • Contact: Kerem Böge, Dr. Dr.; Phone Number: 49 30 450 517 789; Email: Kerem.boege@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blended face-to-face and smartphone intervention for delusional thoughts and experiences; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Deutscher Akademischer Austausch Dienst; Swinburne University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: psychotherapy; psychotic disorders; EMA; EMI; delusions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Delusions
• Other Study ID Numbers: DICE2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No