Clinical trial NCT05868135: Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
Official title: Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression Moderate
Anxiety, Social
Panic Disorder
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: The Hospital of Vestfold
name: Sykehuset Innlandet HF
First posted: 2023-05-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Depression severity
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Social phobia
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Panic disorder symptoms
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Work and social adjustment
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Anxiety severity
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: System Usability
timeFrame: Up to 14 weeks after treatment start (T2)
measure: Depression severity
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Cost of health care services
timeFrame: 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)
measure: Medication
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
measure: Work participation
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
measure: Sickness absenteeism
timeFrame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Bergen HF
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet HF
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold HF
Study officials:
affiliation: St. Olavs Hospital
name: Elin T Ulleberg, Master
role: PRINCIPAL_INVESTIGATOR
References: