Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment

Panic Disorder Clinical Trial

Official title:

Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868135
• Other study ID #: 229387
• Status: Recruiting
• Start date: September 9, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: St. Olavs Hospital
• Contact: Vidar Halsteinli, PhD
• Phone: +4793021081
• Email: vidar.halsteinli[@]stolav.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety, Social
• Depression
• Depression Moderate
• Panic Disorder

Intervention

Behavioral:
• eMeistring
Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit

Locations

Country	Name	City	State
Norway	Helse Bergen HF	Bergen
Norway	Sykehuset Innlandet HF	Lillehammer
Norway	Sykehuset i Vestfold HF	Tønsberg
Norway	St. Olavs Hospital HF	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Haukeland University Hospital, Sykehuset Innlandet HF, The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Primary	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.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Primary	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.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	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.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	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.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	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.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	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.	Up to 14 weeks after treatment start (T2)
Secondary	Depression severity	For social anxiety group an panic disorder 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	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	Cost of health care services	Cost of health care services calculated as sum costs for hospital inpatient stays plus outpatient visits plus home care visits plus nursing home stays plus general practitioner visits plus physiotherapist visits plus other supportive care visits.	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)
Secondary	Medication	Patient reported use of medication, assessed by a separate questionnaire.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary	Work participation	Work participation assessed by questionnaire: Currently employed or not.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Secondary	Sickness absenteeism	Sickness absenteeism assessed by questionnaire: Number of days absent the last four weeks.	Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)