ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1284-6536

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Schizophrenia

Psychosis

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At completion of the 6-weeks of sessions (T2)

Primary outcome [2]

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]

Duration of the therapy, from baseline (T1) through to completion of the 6-week therapy course (T2).

Primary outcome [3]

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]

Duration of the therapy, from baseline (T1) through to completion of the 6-week therapy course (T2).

Secondary outcome [1]

Psychotic symptoms, as measured by the PANSS.

Timepoint [1]