Short summary

This study investigates the effects of using a smartphone app to support SDM for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. The primary objective is to investigate the effect of the app on patient activation 6 months after baseline. Secondary outcomes are positive and negative symptoms, level of functioning; working alliance; self-efficacy; treatment satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction. Explorative outcomes are self-perceived usefulness of the Momentum app.

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Rationale

Background:

Shared decision making (SDM) is associated with positive health outcomes for the patient. While practitioners provide a professional expertise with information on the diagnosis, course of the illness, treatment options and potential side effects, patients are experts on their own needs, treatment preferences and goals. In mental healthcare, SDM have been assessed as a promising treatment intervention to promote patient involvement and clinical guidelines advocate the use of SDM as a patient-centered mental health care and a mean to increase patient empowerment. Although SDM today seems to be a preferred model for clinical decision-making for both patients and providers in mental health, patients indicate that they are not involved as much as they want to be in their treatment. Studies on SDM interventions for people with mental health issues are somewhat sparse and due to a small number of RCT studies, the evidence on SDM in mental health has been concluded as encouraging but inconclusive.

Based on recent research, a digital healthcare solution which links patients and providers together could assist in providing support and potentially promote SDM. Findings from existing randomized controlled trials suggest that electronic aids to support SDM are a promising mean to engage patients in their mental health treatment. Recent systematic reviews do, however, highlight a need for more evidence-based research on the efficacy and effectiveness of mental health apps.

Intervention:

Momentum is a smartphone app, developed to support people with schizophrenia-spectrum disorders to prepare for treatment consultations while becoming more involved in treatment decisions. The app was developed in the period of 2013-2014 to support SDM in the Mental Health Services of the Capital Region of Denmark in a process of co-creation. Afterwards, the app was tested by 116 mental health professionals and 78 patients from three different mental health treatment sites: community of mental health, inpatient- and outpatient treatment sites. The app has since then been optimized based on the feedback received from the study participants.

Aim:

The purpose of this trial is to investigate the effects of the smartphone app Momentum for people with a diagnosis of schizophrenia, schizotypal or delusional disorders within outpatient treatment settings in a randomized design. Our main hypothesis is that patients using the Momentum app in combination with receiving specialized early intervention treatment (i.e. treatment as usual (TAU)), compared to patients only receiving TAU, will show greater improvements in patient activation, measured by the Consumer Health Activation Index - Mental Health Version (CHAI-MH), 6 months after baseline (primary outcome). Our secondary hypothesis is that patients using the Momentum app in combination with receiving TAU, compared to patients only receiving TAU, will show greater improvements regarding self-perceived level of SDM; self-efficacy; the therapeutic alliance; hope and optimism; satisfaction with treatment; patient's confidence in communicating preferences and concerns to their provider; severity of symptoms and; level of functioning (secondary outcomes). Lastly, we hypothesize that there is a correlation between the effects of using the Momentum app and self-reported usefulness of the Momentum app and/or app usage (user sessions per day, screen views per day, screens per session, session duration and session instances, user retention) (explorative outcomes).

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Description of the cohort

The inclusion criteria of the study are:

Adults of both sexes aged 18+

A diagnosis of schizophrenia, schizotypal or delusional disorders (ICD-10 codes: F20-F29)

The patient is currently receiving treatment from the participating OPUS centres in the Mental Health Services of the Capital Region of Denmark

The patient have received treatment for a minimum of 6 months and a maximum of 18 months at the start of the intervention from one of five participating OPUS centre in the Mental Health Services of the Capital Region of Denmark

The exclusion criteria of the study are:

Do not understand or speak Danish

Unable to give written informed consent to participate in the trial at the described terms

Are participating in other research studies involving OPUS treatment and an app

Do not have daily access to a smartphone

Are suffering of mental retardation or dementia (F. 70-F.79, F.00-F.03)

Data and biological material

Questionnaires:

• Primary outcome: The difference in patient activation before participating in the trial and after 6 months participation, assesed  using the Consumer Health Activation Index for Mental Health (CHAI-MH). Completed by patients.
• Self-efficacy (General Self-Efficacy scale (GSE)). Completed by patients.
• Self-perceived level of SDM (Shared Decision Making Questionnaire (SDM-Q)). Completed by patients.
• Hope and optimism (Adult State Hope Scale (ASH)). Completed by patients.
• Patient's confidence in communicating preferences and concerns to their provider (Perceived Efficacy in Patient-Provider Interactions (PEPPI)). Completed by patients.
• Satisfaction with treatment (Client Satisfaction Questionnaire (CSQ)). Completed by patients.
• Self-made questions on the satisfaction and usefulness of the Momentum app. Completed by patients in the intervention group.
• Assessments of the working alliance (Working Alliance Inventory - short version (WAI-S)). Completed by patients and providers.
• Preferences in clinical decision making (Clinical Decision Making Style (CDMS)). Completed by patients and providers.
• Experience of patient collaboration (Service Engagement Scale - Collaboration sub-domain only (SES)). Completed by providers.

 

Clinical data:

• Positive and negative symptoms (Scale for the Assessment of Positive and Negative Symptoms (SAPS and SANS)). Data collected through interview with patients.
• Level of functioning (Global Assessment of Functioning (GAF) and Personal and Social Performance Scale (PSP)). Data collected through interview with patients.
• Use of anti-psychotic medicine. Data collected through interview with patients.
• Diagnosis. Data collected through the patient journal.
• Patient adherence to OPUS appointments. Data collected through the patient journal.
• Hospital admissions. Data collected through the patient journal.
• Months in OPUS treatment. Data collected through the patient journal.

 

Objective data:

• App usage (user sessions per day, screen views per day, screens per session, session duration and session instances, user retention).

Collaborating researchers and departments

The project is funded by TrygFoundation.

The research group for this study consists of:

Competence Centre for Rehabilitation and Recovery, The Mental Health Centre Ballerup, The Mental Health Services of the Capital Region, Denmark

• Tobias Vitger, MSc., Ph.D. Researcher
• Lisa Korsbek, MA. Ph.D., the Momentum Trial research project leader. At the time of Study Start: Senior Researcher, Mental Health Center Ballerup. From August 2019: Program manager on shared decision making in the Mental Health Services at the Region of Southern Denmark.
• Lone Petersen, Head of Competence Centre for Rehabilitation and Recovery, Ph.D, M.Sc. Psychology

The Mental Health Centre Hillerød, The Mental Health Services of the Capital Region, Denmark

• Stephen Austin, Senior Researcher, Ph.D., M.Sc. Psychology

The Research Unit of the Mental Health Centre Copenhagen, The Mental Health Services of the Capital Region, Denmark

• Merete Nordentoft, Professor in clinical psychiatry, MD, DrMSc 

The Mental Health Centre Slagelse, The Mental Health Services of Zealand, Denmark

• Esben S. Tønder, Consultant, MA

Publications associated with the project

Vitger Tobias, Korsbek Lisa, Austin Stephen F., Petersen Lone, Nordentoft Merete, Hjorthøj Carsten. Digital Shared Decision-Making Interventions in Mental Healthcare: A Systematic Review and Meta-Analysis. Front. Psychiatry, 06 September 2021 | https://doi.org/10.3389/fpsyt.2021.691251

Vitger, T., Austin, S.F., Petersen, L. et al. The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial. BMC Psychiatry 19, 185 (2019). https://doi.org/10.1186/s12888-019-2143-2