Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial — INTERMENTAL  

Anxiety Clinical Trial

Official title: Guided Internet-based Interventions in Primary Care: the INTERMENTAL Effectiveness-implementation Randomized Controlled Trial

Status Recruiting

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mild to Moderate Depression

• 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