Mental Health IssueStartHjelpNCT06212687
Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care
A study testing Digital pre-therapy patient education program (StartHjelp) and Comparator intervention in people with Mental Health Issue and Mental Disorder, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Health Issue, Mental Disorder, Patient Education
- What is being tested?
- Digital pre-therapy patient education program (StartHjelp) and Comparator intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- 15 Dec 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- In need of acute help
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St.Olavs Hospital
Trondheim, Trøndelag, 7006
Mariela L Lara-Cabrera, PhD, +4748280188, Mariela.lara@ntnu.no
Henrik Pedersen, cand. psych., +4791697343, Henrik.Pedersen@ntnu.no
About this study
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.
Read the 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.
- Conditions
- Mental Health Issue, Mental Disorder, Patient Education
- Being tested
- Digital pre-therapy patient education program (StartHjelp), Comparator intervention
- Keywords
- Patient education, Patient Satisfaction, Self Efficacy, Pre-therapy, DIgital health, Mental health, Therapy preparation
- Medical subject headings
- Mental Disorders, Patient Satisfaction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital pre-therapy patient education program (StartHjelp)Behavioural
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.
Comparator interventionBehavioural
After randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail.
| Study group | Role | What they receive |
|---|---|---|
| Digital pre-therapy informational intervention (StartHjelp). | Experimental | 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. Receives: Behavioral: Digital pre-therapy patient education program (StartHjelp) |
| Control group | Active comparator | The control group gets sent all the same information as the intervention group in written form, by mail. Receives: Behavioral: Comparator intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: measured on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Mariela L. Lara-Cabrera, Principal investigator, St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)Rolf W. Gråwe, PhD, Prof., Study chair, St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212687
- Sponsor's protocol ID
- 635362 b
- Acronym
- StartHjelp
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care
- ClinicalTrials.gov ID
- NCT06212687
- Acronym / sponsor ID
- StartHjelp / 635362 b
- Conditions
- Mental Health Issue, Mental Disorder, Patient Education
- Keywords
- Patient education, Patient Satisfaction, Self Efficacy, Pre-therapy, DIgital health, Mental health, Therapy preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital pre-therapy informational intervention (StartHjelp). | Experimental | Behavioral: Digital pre-therapy patient education program (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. |
| Control group | Active comparator | Behavioral: Comparator interventionThe control group gets sent all the same information as the intervention group in written form, by mail. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- In need of acute help
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Digital pre-therapy informational intervention (StartHjelp). |
| Comparator interventionAfter randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail. | Behavioural | Control group |
Primary outcome
Patient satisfaction
Time frame: measured on T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)
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).
Patient activation
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)
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.
Knowledge and treatment preferences
Time frame: measured on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)
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.
7 secondary outcomes
Patient enablement
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
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
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
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
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
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
Time frame: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariela L. Lara-Cabrera principal investigator
St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)
Rolf W. Gråwe, PhD, Prof. study chair
St.Olavs Hospital and Norwegian University of Science and Technology (NTNU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital pre-therapy patient education program (StartHjelp) and Comparator intervention in people with Mental Health Issue and Mental Disorder, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariela L. Lara-Cabrera, PhD (+4748280188, Mariela.lara@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: measured on T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.