Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868135
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-04-21
Brief Title:
Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
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:
2024-06
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 locationsclinics 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 locationsclinics 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 hospitalslocations 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 eg 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 criterias 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 hospitalslocations 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 eg 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 criterias 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:
None
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?:
None