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

NCT ID: NCT05868135

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-09

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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The therapist guided internet based cognitive therapy (ICBT) cover moderate depression, social anxiety disorder (SAC) and panic disorder (PD).

The eMeistring-program is standard treatment in all four hospitals/locations participating in the study. Patients are recruited through the ordinary clinical patient pathways. After a pre-treatment assessment, an initial face-to-face visit takes place (T1). Patients are given the opportunity to participate in the study based on informed concent. Next, participants in the depression program will receive eight guided internet based cognitive behavioural therapy sessions or modules. Similarly SAC and PD patients will receive nine modules. Therapist guidance are provided at least once a week via a secure email system. When sessions are finished (T2), a new face-to-face visit with the therapist is offered.

Therapists are licensed health personnel e.g. psychologists, registered nurses and clinical social workers, working in the clinics.

Administrative data about covering organizational implementation of the eMeistring treatment program, personnel involved and level of treatment activity is collected separately.

Inclusion criteria's for eMeistring therapy: having moderate depression, panic disorder and social anxiety disorder as a primary disorder, and having computer and internet access.

Exclusion criteria: severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month), severe reading or writing disabilities.

Adverse events are taken care of through routine follow-up according to the outpatient clinic responsibility. Any responses from patients indicating suicidal behaviour triggers email to the therapist with an urge to follow-up.

Planned statistical analyses include multivariate analyses of effectiveness (intention-to-treat and completers), predictor analyses of drop-out and adherence, and cost-effectiveness analyses based on health related quality of life, intervention costs and other health care and societal costs, analysing location specific differences stratified by patient groups.

Conditions

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Depression Moderate Anxiety, Social Panic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with moderate depression

eMeistring

Intervention Type BEHAVIORAL

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

Patients with social anxiety disorder

eMeistring

Intervention Type BEHAVIORAL

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

Patients with panic disorder

eMeistring

Intervention Type BEHAVIORAL

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

Interventions

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eMeistring

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

The Hospital of Vestfold

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elin T Ulleberg, Master

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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Helse Bergen HF

Bergen, , Norway

Site Status RECRUITING

Sykehuset Innlandet HF

Lillehammer, , Norway

Site Status RECRUITING

St. Olavs Hospital HF

Trondheim, , Norway

Site Status RECRUITING

Sykehuset i Vestfold HF

Tønsberg, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Vidar Halsteinli, PhD

Role: CONTACT

+4793021081

Jørn Heggelund, PhD

Role: CONTACT

+4792409017

Facility Contacts

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Tine Nordgreen, PhD

Role: primary

+4790094913

Hilde S Ludvigsen, Master

Role: primary

+4795175499

Lise T Veium, Master

Role: primary

+4772824988

Elin Katrine Vestly, Master

Role: primary

+4747906120

Other Identifiers

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229387

Identifier Type: -

Identifier Source: org_study_id

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