Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards

NCT06998654 | Not Yet Recruiting DMC

• 1 other identifier: 0-4322
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This qualitative feasibility study investigates a digital health app designed for patients who are frequently admitted to the psychiatric acute ward, to facilitate crisis support outside of office hours to avoid unnecessary readmissions, as well as self-harm. As this is a novel app to be implemented in an already existing service, key uncertainties regarding the intervention content and its delivery needs to be addressed before potentially conducting a full-scale trial, or, alternatively, to inform further intervention refinement. Such uncertainties are appropriate to explore in a feasibility study according to the Medical Research Council (MRC) framework for the development and evaluation of complex interventions. There is a need to investigate whether the app is acceptable and useful to the patients using it, and to the healthcare providers who respond to it. There is also a need to know whether the healthcare providers responding to the app find the task manageable. The context in which the staff are to deliver the intervention, i.e. the in-bed ward, may be subject to different barriers, such as a staff shortage due to sick leave and heavy workload in the ward. Such barriers are essential to identify ahead of possible future trials in other contexts.

Conditions

Mental Health Help-Seeking; Digital Health; Readmissions

Keywords

Digital mental health intervention; self help; crisis support; readmissions

Outcome Measures

Primary Outcomes (4)

• Acceptability of the digital mental health intervention for patients

  Acceptability refers to the degree to which patients feel that the digital health service is appropriate, comfortable, and aligned with their needs and values. Focus: How patients perceive the app in terms of relevance, usability, and emotional response. Data Source: Semi-structured interviews. Research Questions: * How do patients experience using the app? * What aspects of the app do they find helpful or frustrating? * Would they be willing to use it again?

  From enrollment to the end of trial phase, 3 months.

• Acceptability of the digital mental health intervention for healthcare providers

  Acceptability refers to the extent to which the digital intervention fits within clinical routines, professional standards, and ethical expectations. Focus: How healthcare workers perceive the app's fit with their workflow, values, and patient care. Data Source: Focus group interviews. Research Questions: * How do healthcare workers experience integrating the app into their practice? * What concerns or benefits do they identify? * Does the app align with their professional judgment and routines?

  From enrollment to end of trial phase, 3 months

• Perceived usefulness of the digital mental health intervention for patients

  Usefulness is understood as the degree to which the intervention helps users achieve their goals or solve a problem. Focus: Whether the app is seen as beneficial in supporting patient self-management. Data Source: Interviews with patients Research Questions: * In what ways do users feel the app supports their needs and goals? * Are there features they find particularly valuable or lacking?

  From enrollment to the end of trial phase, 3 months.

• Perceived usefulness of the intervention for healthcare providers

  Usefulness is understood as the extent to which the digital service contributes to improved care delivery, decision-making, or communication with patients. Focus: Whether the app is seen as beneficial in supporting clinical care. Data Source: Focusgroup interviews. Research Questions: * In what ways do users feel the app supports them in their clinical care? * Are there features they find particularly valuable or lacking?

  From enrollment to the end of trial phase, 3 months.

Secondary Outcomes (3)

• Number of contacts with health services

  From enrollment to the end of trial, 3 months

• Implementation feasibility of the digital intervention

  From enrollment to the end of trial phase, 3 months.

• Fidelity to protocol

  From enrollment to the end of trial phase, 3 months

Other Outcomes (1)

• Exploration of unintended negative effects

  From enrollment to end of trial phase, 3 months

Study Arms (1)

Muli-app

OTHER

The feasibility study will be conduced using a concurrent mixed methods design, where quantitative and qualitative data are collected simultaneously. The trial will be run in two neighbouring municipalities in Norway that are affiliated with the same university hospital. To allow for sufficient time to engage with the intervention, the two trial-phases will be run, each lasting 3 months. For patients, the intervention will be tested in real-life situations, wherever they lead their everyday lives. Qualitative data will be collected through individual interviews in the patients' preferred settings. App-usage data will be collected through the app-platform. For staff, qualitative data will be collected through focus group interviews at the local psychiatric hospital tasked with responding when patients make contact through the app. Suitable meeting rooms will be provided to ensure privacy.

Behavioral: Muli-app

Interventions

Muli-app BEHAVIORAL

The Muli-app is designed after a traffic-light model, indicating different levels of severity of emotional distress and need for help. Green parts represent self-management measures that can be taken to try to regulate themselves (coping plan, write notes for their next appointment , and exercises to reduce emotional distress.) Yellow parts represent contact-based measures when the patient needs someone to talk to outside office hours, to de-escalate emotional distress and to avoid further crisis. This function connects study participants with mental health professionals at the local psychiatric hospital outside office hours (chat, phone or videocall). When the patient activates this function, the staff at the local hospital have 30 minutes to reply. The red part also activates contact with the local psychiatric hospital, but with a need of acute response, activating acute measures stated in the coping plan, such as access to an open bed in the municipality.

Muli-app

Eligibility Criteria

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

You may qualify if:

• older than 18 years
• reside in one of the study municipalities
• admitted into the Muli service
• have had at least three admissions into the psychiatric acute ward in the last 12 months
• \- staff members at the local psychiatric hospital who respond to patient contacts made through the app

You may not qualify if:

• \- staff members at the local psychiatric hospital who rare not tasked with responding to patient contacts made through the app.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Western Norway University of Applied Sciences: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Study Officials

• Mette Senneseth, Phd

  Centre for research and education in forensic psychiatry, Haukeland Univeristy Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ane A Buer, Phd candidate

CONTACT

+47 45054749; anabu@hvl.no

Mette Senneseth, Phd

CONTACT

+47 41208207; mette.senneseth@helse-bergen.no

Study Design

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

Model Details: The present study is a feasibility study of a digital mental health intervention, "the Muli-app". The app is developed through an iterative process with different stakeholders, peers and service users, and will be tested with 5 service users (patients) in this feasibility study.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: May 31, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)