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Clinical Trial 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 and blended CBT in primary care. Primary objective: Examine the non-inferiority of guided internet-based cognitive behavioural treatment "Assistert Selvhjelp" (AS-iCBT) and blended CBT (bCBT) compared to face-to-face (F2F)-CBT for anxiety and depression in primary care with regard to effects on symptoms of anxiety and depression. Secondary objectives: (i) Examine the non-inferiority of AS-iCBT and bCBT compared to F2F-CBT 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 and bCBT compared to F2F-CBT; (iii) Examine to what extent moderators and mediators of change are associated with treatment effectiveness of AS-iCBT and bCBT; (iv) Assess whether AS-iCBT and bCBT are as acceptable and appropriate for treatment of anxiety and depression as F2F-CBT, and examine barriers/facilitators for their further implementation.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05118828
Study type Interventional
Source Norwegian Institute of Public Health
Contact Robert Smith, PhD
Phone +4794236412
Email [email protected]
Status Recruiting
Phase N/A
Start date October 20, 2021
Completion date October 18, 2025

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