An interventional study of Digital pre-therapy patient education program (StartHjelp) and Comparator intervention in Mental Health Issue, Mental Disorder and Patient Education, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Other
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.
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 170 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Digital pre-therapy patient education program (StartHjelp)
The control group gets sent all the same information as the intervention group in written form, by mail.
Behavioral: Comparator intervention
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.
After randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail.
Patient satisfaction
Patient satisfaction with the client satisfaction questionnaire (CSQ). The CSQ prompts the patient to evaluate different aspects of the care received with an 4 point ordinal scale (very dissatisfied, somewhat dissatisfied, somewhat satisfied, very satisfied).
Time frame: measured on T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
Patient activation
Patient activation measure 13 will be used. This questionaire measures patient activation by asking about knowledge, skills, and ability to manage one's own health, and health care usage. It consists of 13 items which is answered on an 4 point ordinal scale (Strongly disagree, somewhat disagree, somewhat agree, and strongly agree. Respondents have the option to answer "not applicable to me" as well.
Time frame: 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)
Knowledge and treatment preferences
Knowledge will be measured by five questions. All questions are introduced by "how much knowledge do you have about" (how outpatient clinics work; what happens in therapy; self management and user participation; patient rights; treatment options available to you). These questions are answered on a six-point ordinal scale ranging from "Nothing" to "Very much". After these 5 questions a follow up question "do you know what type of treatment you want?", answered either "yes", "no", or "don't know", is asked. If the answer is "yes" the patient is prompted to write what it is that they want.
Time frame: measured on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)
Patient enablement
To measure patient enablement the PEN-13 will be used. The PEN-13 is a 13 item questionnaire which measure patient enablement across two domains (patient practitioner interaction and self management). The answers are given on a five-point Likert scale (strongly disagree, disagree, neither/nor, agree, and strongly agree).
Time frame: 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)
Level of functioning
Work and social adjustment, or level of functioning, is measured by the Work and Social Adjustment Scale (WSAS). The WSAS have five items that measure functioning across different domains: Work, home management, social leisure activities, private leisure activities, and close relationships. Each question is answered on a 0 to 8 scale, where 0 means "not at all" impaired, and 8 means "very severely" impaired.
Time frame: 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)
Mental health
Mental health will be measured the Patient Health questionnaire 4. A four-item questionnaire with two items measuring the severity of anxiety symptoms and two items measuring the severity of depression symptoms.
Time frame: 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)
Perceived stress
Perceived stress will be measured by Perceived stress Scale-4, which comprise of four items scored on a five-point ordinal scale scored 0-4. Answers range from Never to very often.
Time frame: 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)
Health related Quality of life
Health related quality of life will be measured with the EQ-5D-5L. This questionnaire measure health related quality of life with five items, where each items prompts the patient to evaluate their "problem level" across a specific domain (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Question responses are ordinal and include "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". Respondents are also asked to rate their health on a 0-100 scale.
Time frame: 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)
Intentions for patient involvement
Intentions for patient involvement were measured by asking the question "How much do you want to participate in decisions related to your treatment measured on a six point ordinal scale ranging from "nothing" to "very much".
Time frame: 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)
Expectations
To investigate patients' expectations about the interventions an open question "What are your expectations for this intervention".
Time frame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Costs
Cost of app development and maintenance are being tracked to compare it against its outcomes to evaluate its cost-benefit.
Time frame: T4 (24 months follow up; up to 112 weeks)
App engagement
To measure app engagement, anonymized data of app usage will be gathered through the app itself.
Time frame: T2 (after intervention; up to 8 weeks)
health care usage
Data from official patient registries will be used to track (drop out, number of consultations, type of treatment)
Time frame: T4 (24 months follow up; up to 112 weeks)
System usability
To test the usability of the app itself the System Usability Scale will be used, a widely used 10-item scale that measure how the user experience using and trying to understand a digital tool.
Time frame: T2 (after intervention; up to 8 weeks)
Alcohol use disorder test
To screen for alcohol use disorders Alcohol Use Disorders Identification Test (AUDIT) will be used. AUDIT has 10 items and uses the last 12 months as a reference for answering.
Time frame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Drug use disorder test
To screen for drug use disorders Drug Use Disorders Identification Test (DUDIT) will be used. DUDIT has 11 items and uses the last 12 months as a reference for answering.
Time frame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Work status
Data from official patient registries will be used to track work status (disability status, employment or sick leave).
Time frame: T4 (24 months follow up; up to 112 weeks)
Plan to share: No
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Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 24 months is below that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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