Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eMeistring.
- Who it may be relevant to
- Registry conditions: Depression Moderate, Anxiety, Social, Panic Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial
Overview
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
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.
Interventions
- Behavioral eMeistring
Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit
Primary outcome measures
- Depression severity [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- Social phobia [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- Panic disorder symptoms [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
Secondary outcome measures (9)
- Health Related Quality of Life [Time frame: 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 [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- Anxiety severity [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- System Usability [Time frame: Up to 14 weeks after treatment start (T2)]
- Depression severity [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- Cost of health care services [Time frame: Period between pre treatment (T1) and up to 14 weeks after treatment start (T2), and to six months after post treatment (T3) and until two years (T4)]
- Medication [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
- Work participation [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)]
- Sickness absenteeism [Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 4 centers
- Helse Bergen HF — Bergen
- Sykehuset Innlandet HF — Lillehammer
- St. Olavs Hospital HF — Trondheim
- Sykehuset i Vestfold HF — Tønsberg
Identifiers
NCT: NCT05868135 · 229387