Psychotic DisorderDICENCT06207526
Delusion Ideation in the Context of Everyday Life
A study testing Blended face-to-face and smartphone intervention in people with Psychotic Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Blended face-to-face and smartphone intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 1220
Kerem Böge, Dr. Dr., 49 30 450 517 789, Kerem.boege@charite.de
About this study
Official title: 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).
Read the 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.
- Conditions
- Psychotic Disorder
- Being tested
- Blended face-to-face and smartphone intervention
- Keywords
- psychotic disorders, psychotherapy, EMA, EMI, delusions
- Medical subject headings
- Psychotic Disorders, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended face-to-face and smartphone interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Blended face-to-face and smartphone intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start6 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutscher Akademischer Austausch Dienst, Swinburne University of Technology
- Responsible party
- Principal investigator, Kerem Böge, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207526
- Sponsor's protocol ID
- DICE2023
- Acronym
- DICE
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delusion Ideation in the Context of Everyday Life: a Novel Smartphone-supported Psychological Therapy Approach (DICE)
- ClinicalTrials.gov ID
- NCT06207526
- Acronym / sponsor ID
- DICE / DICE2023
- Conditions
- Psychotic Disorder
- Keywords
- psychotic disorders, psychotherapy, EMA, EMI, delusions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutscher Akademischer Austausch Dienst, Swinburne University of Technology
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blended face-to-face and smartphone intervention for delusional thoughts and experiences | Experimental | Behavioral: Blended face-to-face and smartphone interventionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended face-to-face and smartphone interventionThe 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. | Behavioural | Blended face-to-face and smartphone intervention for delusional thoughts and experiences |
Primary outcome
Feasibility and acceptability of the intervention
Time frame: Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
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).
Acceptability of the intervention
Time frame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
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).
Side effects
Time frame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Negative effects will be recorded by using the Negative Incidents and Effects Questionnaire (Rozental et al., 2019).
7 secondary outcomes
Objective intensity of delusions
Time frame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Subjective intensity of delusions
Time frame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Psychological distress
Time frame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Stress, anxiety and depression
Time frame: At baseline and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
self-assessed recovery
Time frame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Delusional ideation
Time frame: At baseline, during EMA and post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Adverse events
Time frame: Post-intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended face-to-face and smartphone intervention in people with Psychotic Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerem Böge, PD Dr. Dr. ((+49)30 - 450 517636, kerem.boege@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the intervention (time frame: Post-Intervention (after completion of 4 face-to-face psychotherapy sessions; 4-6 weeks from baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.