Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
NCT ID: NCT05868135
Last Updated: 2025-06-05
Study Results
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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RECRUITING
800 participants
OBSERVATIONAL
2021-09-09
2027-12-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with moderate depression
eMeistring
Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit
Patients with social anxiety disorder
eMeistring
Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit
Patients with panic disorder
eMeistring
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
The Hospital of Vestfold
OTHER
Sykehuset Innlandet HF
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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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
Sykehuset Innlandet HF
Lillehammer, , Norway
St. Olavs Hospital HF
Trondheim, , Norway
Sykehuset i Vestfold HF
Tønsberg, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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229387
Identifier Type: -
Identifier Source: org_study_id
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