Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care

NCT ID: NCT06212687

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2030-12-31

Brief Summary

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Community mental health centers (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand, there are long waiting lists and low engagement rates. Innovative interventions are urgently needed to address these challenges to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient activation and treatment satisfaction in other contexts. They may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this study aims to evaluate a digital pre-therapy patient education program tailored specifically for adults with mental disorders. This intervention aims to enhance treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes.

Detailed Description

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Community mental health centers (CMHCs) play a pivotal role in the provision of comprehensive care and support for individuals with mental health challenges. However, these centers often face formidable obstacles, including surging patient demands, lengthy waiting lists, high dropout rates, and barriers to engagement, stigma, and negative attitudes. Given these challenges, there exists an urgent imperative to develop innovative interventions that can enhance treatment satisfaction, patient activation, knowledge, and patient engagement, and ultimately yield improved mental health outcomes. One promising approach for addressing these challenges lies in the realm of patient engagement and enablement strategies, particularly through the implementation of digital educational interventions.

The investigators hypothesize that utilizing innovative technology to deliver an early digital self-management educational program improves treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes without substantially increasing service costs. The impact of utilizing innovative technology to deliver an early digital pre-therapy patient education program through the HelsaMi web patient portal is promising. By leveraging technology, it is possible to reach a wider audience and provide accessible and convenient information, with the same standard to all patients. This approach has the potential to improve patient outcomes, increase treatment adherence, and reduce the burden on healthcare resources. By demonstrating the benefits of digital interventions, our research will pave the way for more efficient and cost-effective mental healthcare services, benefiting both patients and healthcare systems.

Conditions

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Mental Health Issue Mental Disorder Patient Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention is a pre-therapy informational app, presenting information about the treatment process, options, patient rights, user organizations, and self-help while on waiting list before mental health outpatient treatment. The information is delivered stepwise through video and text, while also providing links to additional information if needed. The videos are made available to the patients gradually, with more general information about the treatment process first, and more specific information as the first session approaches. The patient has the opportunity to rewatch the videos if needed.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Digital pre-therapy informational intervention (StartHjelp).

Patients gets access to StartHjelp, an app which gradually present treatment relevant information while the patient is on waiting list for mental health outpatient services.

Group Type EXPERIMENTAL

Digital pre-therapy patient education program (StartHjelp)

Intervention Type BEHAVIORAL

After randomization the intervention group receives access to a pre-therapy informational app, presenting information about the treatment process, options, patient rights, user organizations, and self-help while on waiting list before mental health outpatient treatment. The information is presented stepwise through video and text, while also providing links to additional information if needed. The videos are made available to the patients gradually, with more general information about the treatment process first, and more specific information as the first session approaches. The patient has the opportunity to rewatch the videos as they please.

Control group

The control group gets sent all the same information as the intervention group in written form, by mail.

Group Type ACTIVE_COMPARATOR

Comparator intervention

Intervention Type BEHAVIORAL

After randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail.

Interventions

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Digital pre-therapy patient education program (StartHjelp)

After randomization the intervention group receives access to a pre-therapy informational app, presenting information about the treatment process, options, patient rights, user organizations, and self-help while on waiting list before mental health outpatient treatment. The information is presented stepwise through video and text, while also providing links to additional information if needed. The videos are made available to the patients gradually, with more general information about the treatment process first, and more specific information as the first session approaches. The patient has the opportunity to rewatch the videos as they please.

Intervention Type BEHAVIORAL

Comparator intervention

After randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Put on the waiting list for mental health outpatient treatment in the active study period.
* Willing to participate in the study
* Over 18 years
* Understand written and spoken Norwegian

Exclusion Criteria

* In need of acute help
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariela L. Lara-Cabrera

Role: PRINCIPAL_INVESTIGATOR

St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)

Rolf W. Gråwe, PhD, Prof.

Role: STUDY_CHAIR

St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)

Locations

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St.Olavs Hospital

Trondheim, Trøndelag, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Mariela L. Lara-Cabrera, PhD

Role: CONTACT

+4748280188

Henrik Pedersen, Cand. Psych.

Role: CONTACT

+4791697343

Facility Contacts

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Mariela L Lara-Cabrera, PhD

Role: primary

+4748280188

Henrik Pedersen, cand. psych.

Role: backup

+4791697343

Other Identifiers

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635362 b

Identifier Type: -

Identifier Source: org_study_id

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