Delusion Ideation in the Context of Everyday Life

NCT06207526 | Unknown

• 1 other identifier: DICE2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychotic Disorder

Keywords

psychotic disorders; psychotherapy; EMA; EMI; delusions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Objective intensity of delusions

  At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)

• Subjective intensity of delusions

  At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)

• Psychological distress

  At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)

• 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

  Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Blended face-to-face and smartphone intervention BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be between 18 and 65 years old
• fulfill the diagnostic criteria for schizophrenia as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) (Sheehan et al., 1998)
• 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).
• sufficient knowledge of German
• have not undergone a recent (\<6 weeks) or planned change in antipsychotic and other psychopharmacological medication
• know how to use a smartphone or be willing to learn how to use it
• Time availability to attend 4 therapy appointments with two additional rating appointments

You may not qualify if:

• Severe visual impairment
• Acute suicidal tendencies
• Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green Paranoid Thoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Deutscher Akademischer Austausch Dienst: collaborator
• Swinburne University of Technology: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 1220, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Delusions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Kerem Böge, PD Dr. Dr.

CONTACT

(+49)30 - 450 517636; kerem.boege@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 17, 2024
• Study Start: April 6, 2023
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)