Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment

NCT05868135 | Recruiting

• 1 other identifier: 229387
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this observational multicentre study is to address the effectiveness and cost-effectiveness of providing a therapist guided internet based cognitive behavioural therapy (ICBT) for common mental disorders in a routine healthcare setting. Main research questions is 1) What is the effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics in routine care? 2) What is the cost-effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics? 3) Who benefits from guided internet-delivered treatment? 4) What are the predictors of drop-out from guided internet based treatment? 5) To what extent does user experiences of guided internet based treatment influence adherence and effectiveness? Participants will receive up to nine guided ICBT sessions (modules) and answer questionnaires covering symptoms severity, health related quality of life, work and social ability, user satisfaction and medication. All questionnaires are part of the standard patient follow up routines in the four treatment locations participating in the study. Analytical approach is to compare locations/clinics and subgroups of patients.

Conditions

Depression Moderate; Anxiety, Social; Panic Disorder

Outcome Measures

Primary Outcomes (3)

• Depression severity

  For moderate depression group: Depression severity assessed by PHQ-9, Patient Health Questionnaire score. Minimum score is 0, maximum score is 27. Higher score indicates more severe depression

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

• Social phobia

  For social anxiety group: Social Phobia assessed by SPIN, Social Phobia Inventory score. Minimum score is 0, maximum score is 68. Higher score indicates more severe phobia.

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

• Panic disorder symptoms

  For panic disorder group: Panic disorder disorder symptoms assessed by PDSS-SR, Panic Disorder Severity Scale. Minimum raw score: 0, maximum raw score: 28. Composite scores range from 0-4. The composite score is the average of the seven items. Higher score indicates higher severity of panic disorder.

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

Secondary Outcomes (9)

• Health Related Quality of Life

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

• Work and social adjustment

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

• Anxiety severity

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

• System Usability

  Up to 14 weeks after treatment start (T2)

• Depression severity

  Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)

Study Arms (3)

Patients with moderate depression

Behavioral: eMeistring

Patients with social anxiety disorder

Behavioral: eMeistring

Patients with panic disorder

Behavioral: eMeistring

Interventions

eMeistring BEHAVIORAL

Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit

Patients with moderate depression; Patients with panic disorder; Patients with social anxiety disorder

Eligibility Criteria

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

Study Population

Population living in the geographical areas in which provision of specialized health care services are the resonsibility of the four health enterprices/locations participating in the study.

You may qualify if:

• Having moderate depression, panic disorder and social anxiety disorder as a primary disorder. Access to computer and internet.

You may not qualify if:

• Having severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month, severe reading or writing disabilities.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Haukeland University Hospital: collaborator
• The Hospital of Vestfold: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (4)

Helse Bergen HF

Bergen, Norway

RECRUITING

Sykehuset Innlandet HF

Lillehammer, Norway

RECRUITING

St. Olavs Hospital HF

Trondheim, Norway

RECRUITING

Sykehuset i Vestfold HF

Tønsberg, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elin T Ulleberg, Master

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vidar Halsteinli, PhD

CONTACT

+4793021081; vidar.halsteinli@stolav.no

Jørn Heggelund, PhD

CONTACT

+4792409017; jorn.heggelund@stolav.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: September 9, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)