Clinical trial NCT06212687: Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care
Official title: Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Mental Disorder
Patient Education
Keywords: Patient education
Patient Satisfaction
Self Efficacy
Pre-therapy
DIgital health
Mental health
Therapy preparation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2024-01-19
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: measured on T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Patient activation
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Knowledge and treatment preferences
timeFrame: measured on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)
Secondary outcomes:
measure: Patient enablement
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Level of functioning
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Mental health
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Perceived stress
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Health related Quality of life
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Intentions for patient involvement
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
measure: Expectations
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Other outcomes:
measure: Costs
timeFrame: T4 (24 months follow up; up to 112 weeks)
measure: App engagement
timeFrame: T2 (after intervention; up to 8 weeks)
measure: health care usage
timeFrame: T4 (24 months follow up; up to 112 weeks)
measure: System usability
timeFrame: T2 (after intervention; up to 8 weeks)
measure: Alcohol use disorder test
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
measure: Drug use disorder test
timeFrame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
measure: Work status
timeFrame: T4 (24 months follow up; up to 112 weeks)
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
state: Trøndelag
Study officials:
affiliation: St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)
name: Mariela L. Lara-Cabrera
role: PRINCIPAL_INVESTIGATOR
affiliation: St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)
name: Rolf W. Gråwe, PhD, Prof.
role: STUDY_CHAIR
References: