Clinical Trials Logo

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

n/a


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

See also
  Status Clinical Trial Phase
Recruiting NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
Completed NCT04127097 - The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels N/A
Completed NCT04012580 - Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Recruiting NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Active, not recruiting NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Completed NCT03849924 - Enhancing One's Sense of Self Using Self-Affirmation N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A