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Trial registered on ANZCTR


Registration number
ACTRN12622001468718
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
21/11/2022
Date last updated
21/11/2022
Date data sharing statement initially provided
21/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the “Cogito” smartphone app a feasible and effective “assistant” to metacognitive training for people with psychosis?
Scientific title
Feasibility of integrating the “Cogito” therapy-homework smartphone app to metacognitive training for people with psychosis; a pilot trial.
Secondary ID [1] 308330 0
None
Universal Trial Number (UTN)
U1111-1284-6536
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 328118 0
Psychosis 328119 0
Condition category
Condition code
Mental Health 325175 325175 0 0
Schizophrenia
Mental Health 325254 325254 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will implement an evidence-based treatment program for people with schizophrenia (MCT+; metacognitive training). Therapy homework will be delivered via a recently created MCT+ companion smartphone app, Cogito. The study will record how often participants use the homework app between sessions, and assess participants perceptions of the app.

MCT+ (Metacognitive Training) teaches participants to “think about their thinking” through a series of collaborative activities and exercises. This metacognitive awareness of their thoughts “plants the seeds of doubt” and has been shown to reduce the severity of delusional symptoms in people with psychosis. However, as with all psychological therapies, participants should keep practicing the lessons learnt and exercises/experiments covered in sessions outside of therapy session as ‘homework’; something that remains a logistical challenge, particularly in people with psychosis. Delivering therapy ‘homework’ via a smartphone app has the potential to increase engagement and compliance. However, access to—and a desire to use—suitable smartphone devices or the apps they employ may be limited in people with psychosis. This pilot study will look at the feasibility and acceptance of homework delivered via smartphone in this population.

MCT+ will be delivered in one-on-one face-to-face sessions by people with at minimum 4-year psychology degrees, across a period of six weeks, in the form of six sessions (1/week) lasting approximately 60-minutes/session (up to 90-minutes at most):
• The initial ‘baseline’ session will assess participants current psychosis symptomology using the relevant sections of standardized, brief, diagnostic interviews (i.e., The Positive and Negative Syndrome Scale (PANSS) for schizophrenia and Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS)). This interview is designed to be as rapid and non-invasive as possible, while still yielding an accurate validation of presumed diagnosis and symptoms. Participants will be introduced to the MCT+ program in this session and be trained in the use of the companion app “Cogito”. During this session, participants will also be asked to complete three short computer-based tasks, designed to measure participants tendency to jump to conclusions (the probabilistic ‘beads task’ where participants make judgments about which jar some coloured beads are being drawn from), belief inflexibility (where participants rate the plausibility of different interpretations across several distinct scenarios) and overconfidence (where participants read words on the screen and make simple confidence judgments about those words – e.g., how confident are you that this word was presented in the previous list of words?). In total, the interview and tasks will last approximately 60-90-minutes to complete.
• The following four sessions will present and work though the MCT+ modules. These modules do not have a set order and contain overlapping content. A session involves presenting information about a specific cognitive bias, performing exercises illustrating the bias, and relating the bias to the participants real life experiences. While up to 90-minutes is scheduled for each session, the length is flexible, and substantial learning can occur in shorter sessions. If a participant is unable to attend a session, they will still be offered the full course of six sessions and be able to make up the session either later in the week or the following week. As the content has no set order, and overlaps between sessions, the delivery is very flexible to the weekly life circumstances of the participant. Between sessions participants will be asked to spend 5 minutes a day using the Cogito app.
• The final ‘follow-up’ session will repeat the measures from the initial ‘baseline’ session, and participants will evaluate the MCT+ sessions and, importantly, the Cogito app.

We seek to test the feasibility of integrating a companion smartphone app called “Cogito” into the established MCT+ program. Cogito is a simple text-based app and is designed to be used as homework between sessions. The app provides a brief daily reminder of the lessons learnt during therapy.). Cogito contains modules specifically designed for MCT/MCT+ for psychosis. The app has once daily exercises that consist of reading 150-200 words of text that remind and reinforce the material learned in sessions (e.g., the app may briefly outline a lesson learned in therapy and ask the participant to think about a situation that may have been applicable in their life). Each exercise is designed to take no more than a few minutes. The app sends optional once daily reminders (via discrete mobile push notifications) when a new exercise is ready. The app records the number of exercises completed and at the end of each week provides participants with a summary. The app can also be personalized by favouriting the most helpful exercises and deleting those that are unhelpful. It is also possible to add your own exercises by using the smartphone camera to take and upload photos.

Cogito app use will be monitored using daily SMS surveys to participants, and overall perceptions of the app will be assessed with a study-specific questionnaire in the final (sixth) MCT session.
Intervention code [1] 324780 0
Behaviour
Intervention code [2] 324854 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332995 0
Feasibility of integration of the Cogito smartphone app into metacognitive training therapy, as assessed by a 15-item 7-point Likert scale evaluation questionnaire (e.g., 'I found the exercises on the app useful.' and 'The app sent me too many notifications.') and an open-ended qualitative question gauging feedback about the app.
Timepoint [1] 332995 0
At completion of the 6-weeks of sessions (T2)
Primary outcome [2] 332996 0
Usage of the app, as measured by responses to a daily SMS survey ("Did you use the Cogito App today? Please respond Y for yes, and N for No.").
Timepoint [2] 332996 0
Duration of the therapy, from baseline (T1) through to completion of the 6-week therapy course (T2).
Primary outcome [3] 332997 0
Feasibility of integration of the Cogito smartphone app into metacognitive training therapy, as assessed by responses on a 5-point Likert scale questionnaire delivered via daily SMS surveys ("...please include a rating of how helpful you found it on a scale of 1 to 5, where 1 is “not at all helpful”, 3 is “somewhat helpful” and 5 is “very helpful”.")
Timepoint [3] 332997 0
Duration of the therapy, from baseline (T1) through to completion of the 6-week therapy course (T2).
Secondary outcome [1] 415491 0
Psychotic symptoms, as measured by the PANSS.
Timepoint [1] 415491 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [2] 415494 0
Frequency of delusions and severity, as measured by the PSYRATS.
Timepoint [2] 415494 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [3] 415495 0
Cognitive biases, assessed by the Beads Task (jumping to conclusions bias).
Timepoint [3] 415495 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [4] 415496 0
Anxiety symptoms as assessed by the DASS-21.
Timepoint [4] 415496 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [5] 415497 0
Depression symptoms as assessed by the DASS-21.
Timepoint [5] 415497 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [6] 415498 0
Vivid mental experiences and beliefs and hallucinatory experiences, as measured by the Peters et al. Delusions Inventory (PDI-21)
Timepoint [6] 415498 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [7] 415499 0
Self-certainty and self-reflectiveness as measured by the Beck Cognitive Insight Scale. This will be assessed as a composite outcome.
Timepoint [7] 415499 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [8] 415839 0
Frequency of hallucinations and severity, as measured by the PSYRATS.
Timepoint [8] 415839 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [9] 415840 0
Cognitive biases, assessed by the BADE task (belief flexibility).
Timepoint [9] 415840 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).
Secondary outcome [10] 415841 0
Vivid mental experiences and beliefs and hallucinatory experiences, as measured by the Community Assessment of Psychic Experiences (CAPE: a self-report instrument for the measurement of psychotic experiences in the general population).
Timepoint [10] 415841 0
Baseline (T1) and at the completion of the 6-week therapy course (T2).

Eligibility
Key inclusion criteria
Must be aged between 18-65 years and have a diagnosis of schizophrenia.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if their medical treating team does not believe that they are stable and low-risk, such that they are suitable for, and may potentially benefit from, MCT+ therapy sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The study is a feasibility study, looking for preliminary information on the acceptance and viability of therapy homework being delivered via a smartphone app in a population with psychosis. As this is a feasibility study are looking to recruit a small number of participants (20). The small number of participants mean the study will have a low power level; however, it will allow us to obtain initial feedback on the app, including usage patterns and subjective experience ratings. This feedback will help us assess if launching a full-scale study in the future is practical.
Recent meta-analysis of MCT for psychosis found a medium-large effect size (g = 0.69) for reduction of delusions (Penney et al., 2022). Calculations using G*Power (Version 3.1.9.7) give a power of 83% to detect this effect with a sample size of N = 20.

It is proposed to use regression and t-tests to compare the change in secondary outcomes from time 1 to time 2. It is proposed to use chi-square and t-tests to analyze the primary outcome data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
19/01/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23490 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 38897 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 312575 0
Charities/Societies/Foundations
Name [1] 312575 0
Freemasons Centre for Male Health and Wellbeing
Country [1] 312575 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide 5001, South Australia
Country
Australia
Secondary sponsor category [1] 314182 0
None
Name [1] 314182 0
Address [1] 314182 0
Country [1] 314182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311901 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311901 0
Ethics committee country [1] 311901 0
Australia
Date submitted for ethics approval [1] 311901 0
01/08/2022
Approval date [1] 311901 0
06/10/2022
Ethics approval number [1] 311901 0
2022/HRE00127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122774 0
Dr Ryan Balzan
Address 122774 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 122774 0
Australia
Phone 122774 0
+61 08 8201 3082
Fax 122774 0
Email 122774 0
ryan.balzan@flinders.edu.au
Contact person for public queries
Name 122775 0
Ryan Balzan
Address 122775 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 122775 0
Australia
Phone 122775 0
+61 08 8201 3082
Fax 122775 0
Email 122775 0
ryan.balzan@flinders.edu.au
Contact person for scientific queries
Name 122776 0
Ryan Balzan
Address 122776 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 122776 0
Australia
Phone 122776 0
+61 08 8201 3082
Fax 122776 0
Email 122776 0
ryan.balzan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Feasibility/pilot trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.