Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Contr… (NCT05118828) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial
Norway1,000 participantsStarted 2021-10-20
Plain-language summary
Internet-based cognitive behavioral therapy for anxiety and depression have far-reaching potential to overcome common barriers to accessing evidence-based treatment, such as waiting lists, travel distance and costs. Despite the undeniable promise of iCBT, several aspects remain poorly understood and warrants further study.
The INTERMENTAL project is a joint effort between Norwegian Institute of Public Health, Norwegian Directorate of Health and six Prompt Mental Health Care (PMHC) services, situated in 11 municipalities, to evaluate the iCBT interventions developed by the technology company "Assistert Selvhjelp" (AS-iCBT). We will conduct a large-scale hybrid effectiveness-implementation randomized controlled non-inferiority trial that will provide new knowledge on the effectiveness, cost-effectiveness and implementation of AS-iCBT in primary care.
Primary objective: Examine the non-inferiority of guided internet-based cognitive behavioural treatment "Assistert Selvhjelp" (AS-iCBT) compared to treatment as usual in the primary care service Prompt Mental Health Care (TAU-PMHC) with regard to effects on symptoms of anxiety and depression.
Secondary objectives: (i) Examine the non-inferiority of AS-iCBT compared to TAU-PMHC on other outcomes such as quality of life, functional level, specific anxiety measures (social anxiety, panic disorder), sleep and employment status; (ii) Examine the cost-effectiveness of AS-iCBT compared to TAU-PMHC; (iii) Examine to what extent moderators and mediators of change are associated with treatment effectiveness of AS-iCBT; (iv) Assess whether AS-iCBT is as acceptable and appropriate for treatment of anxiety and depression as TAU-PMHC, and examine barriers/facilitators for their further implementation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of anxiety and/or mild to moderate depression.
* Being above 18 years of age and a resident in the pilot sites.
* Basic verbal and oral Norwegian proficiency.
* Having internet access and ability to use it.
Exclusion Criteria:
* Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, psychotic symptoms, severe substance abuse, and/or personality disorder.
* Two or more previous treatment attempts in secondary care services without effect.
* Serious physical health problem as primary problem.
* Clients that have had treatment at PMHC before and only require a booster session.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an internet-based intervention for anxiety and mild to moderate depression delivered through primary care — could you help me understand whether my specific symptoms and severity level are the kind this study was designed for?
2Since this trial is no longer recruiting, are there similar guided online therapy programs currently available that my primary care team could connect me to, either through a study or as a regular treatment option?
3The trial measures changes in depression and anxiety levels as its main outcomes, but how would we track whether an internet-based approach is actually working for me, and what would be the sign that we need to try something different?
4How does a guided internet-based intervention compare to in-person therapy or medication for mild to moderate depression and anxiety — and is there a reason you'd recommend one over the other as a starting point for my situation?
5Since this is a primary care-based study with no listed phase, what does that tell us about how well-established or experimental this type of digital intervention is, and are there any known risks I should be aware of before considering something like it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.