Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
In need of acute help
Trial design
Design model
Parallel
Treatments tested in this trial
Digital pre-therapy patient education program (StartHjelp)
BehavioralAfter 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 intervention
BehavioralAfter randomization, while on waiting list, the control group gets sent all the same information as the intervention group in written form, by mail.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Digital pre-therapy informational intervention (StartHjelp).Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov