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 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.


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 robert.smith@fhi.no
Status Recruiting
Phase N/A
Start date October 20, 2021
Completion date October 18, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming 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 NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Recruiting NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care