Depression ModerateNCT05868135
Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
An observational study of Depression Moderate and Anxiety, Social, run by St. Olavs Hospital at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Moderate, Anxiety, Social, Panic Disorder
- What is being tested?
- eMeistring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 4 sitesNorway
- Study dates
- 9 Sep 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Having moderate depression, panic disorder and social anxiety disorder as a primary disorder. Access to computer and internet.
Who cannot join
- Having severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month, severe reading or writing disabilities.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Helse Bergen HF
Bergen
Sykehuset Innlandet HF
Lillehammer
Sykehuset i Vestfold HF
Tønsberg
St. Olavs Hospital HF
Trondheim
About this study
Official title: Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness 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.
Read the 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.
- Conditions
- Depression Moderate, Anxiety, Social, Panic Disorder
- Being tested
- eMeistring
- Medical subject headings
- Anxiety Disorders, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMeistringBehavioural
Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate depression | Not described Receives: Behavioral: eMeistring | |
| Patients with social anxiety disorder | Not described Receives: Behavioral: eMeistring | |
| Patients with panic disorder | Not described Receives: Behavioral: eMeistring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Secondary outcomes (9)
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.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: Up to 14 weeks after treatment start (T2)
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
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Measured: 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)
Medication
Patient reported use of medication, assessed by a separate questionnaire.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Work participation
Work participation assessed by questionnaire: Currently employed or not.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Sickness absenteeism
Sickness absenteeism assessed by questionnaire: Number of days absent the last four weeks.
Measured: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start9 Sep 2021
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression ModerateStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, The Hospital of Vestfold, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Elin T Ulleberg, Master, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868135
- Sponsor's protocol ID
- 229387
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial
- ClinicalTrials.gov ID
- NCT05868135
- Acronym / sponsor ID
- 229387
- Conditions
- Depression Moderate, Anxiety, Social, Panic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, The Hospital of Vestfold, Sykehuset Innlandet HF
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate depression | – | Behavioral: eMeistring |
| Patients with social anxiety disorder | – | Behavioral: eMeistring |
| Patients with panic disorder | – | Behavioral: eMeistring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Having moderate depression, panic disorder and social anxiety disorder as a primary disorder. Access to computer and internet.
Key exclusion criteria (1 listed)
- Having severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month, severe reading or writing disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMeistringInitial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit | Behavioural | Patients with moderate depression, Patients with panic disorder, Patients with social anxiety disorder |
Primary outcome
Depression severity
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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
Social phobia
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
Panic disorder symptoms
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
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.
9 secondary outcomes
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)
Work and social adjustment
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Anxiety severity
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
System Usability
Time frame: Up to 14 weeks after treatment start (T2)
Depression severity
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Cost of health care services
Time frame: 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)
Medication
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
Work participation
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Sickness absenteeism
Time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Depression Moderate
Not yet recruitingPhase 1
Shortened LSD Intervention for Major Depressive Disorder
Major Depression Moderate, Major Depression Severe
RecruitingPhase 2
A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety
Depression, Anxiety
RecruitingPhase 2
Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Working Memory, Mild to Moderate Depression
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Major Depressive Disorder
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elin T Ulleberg, Master principal investigator
St. Olavs Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Moderate and Anxiety, Social, run by St. Olavs Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity (time frame: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.