Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05868135
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2023-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
Sponsor:
St. Olavs Hospital
Organization:
Study Overview
Official Title:
Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: