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

NCT06212687 | Recruiting

• 1 other identifier: 635362 b
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Mental Disorder; Patient Education

Keywords

Patient education; Patient Satisfaction; Self Efficacy; Pre-therapy; DIgital health; Mental health; Therapy preparation

Outcome Measures

Primary Outcomes (3)

• 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 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 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 on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)

Secondary Outcomes (7)

• Patient enablement

  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

  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

  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

  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

  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 (7)

• Costs

  T4 (24 months follow up; up to 112 weeks)

• App engagement

  T2 (after intervention; up to 8 weeks)

• health care usage

  T4 (24 months follow up; up to 112 weeks)

Study Arms (2)

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.

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.

Behavioral: Comparator intervention

Interventions

Digital pre-therapy patient education program (StartHjelp) 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.

Digital pre-therapy informational intervention (StartHjelp).

Comparator intervention 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• In need of acute help

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Patient Satisfaction; Psychological Well-Being

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Personal Satisfaction

Study Officials

• Mariela L. Lara-Cabrera

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

  PRINCIPAL INVESTIGATOR

• Rolf W. Gråwe, PhD, Prof.

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

  STUDY CHAIR

Central Study Contacts

Mariela L. Lara-Cabrera, PhD

CONTACT

+4748280188; Mariela.lara@ntnu.no

Henrik Pedersen, Cand. Psych.

CONTACT

+4791697343; henrik.pedersen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 19, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)