Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
eMeistring
BehavioralInitial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit
Treatment groups
800 Participants
are divided into 3 treatment groupsGroup A: Patients with moderate depression1 intervention
Group B: Patients with social anxiety disorder1 intervention
Group C: Patients with panic disorder1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)2
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.
Time frame
Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)3
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.
Time frame
Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)Secondary outcomes
1
Health Related Quality of Life
For all patients: Health related quality of life assessed by EQ-5D-5L index score, EuroQol-5Dimension-5Level index score. Minimum score is 0, maximum score is 1. Higher score indicates higher 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)2
Work and social adjustment
For all patients: Work and social adjustment assessed by Work and Social Adjustment Scale score. Minimum score is 0, maximum score is 40. Higher score indicates worse level of social functioning.
Time frame
Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)3
Anxiety severity
For all patients: Anxiety severity will be assessed by GAD-7, Generalized Anxiety Disorder 7-item score. Minimum score is 0, maximum score is 21. Higher score indicates more severe anxiety.
Time frame
Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)4
System Usability
For all patients: System usability will be assessed by the System Usability Scale Score. Minimum score is 0, maximum score is 100. Higher SUS scores indicate better usability.
Time frame
Up to 14 weeks after treatment start (T2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Haukeland University Hospital
Collaborator
The Hospital of Vestfold
Collaborator
Sykehuset Innlandet HF
Collaborator
Source ClinicalTrials.gov