NCT05118828: INTERMENTAL

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

Active, enrolled NA Last updated 11 December 2024

What this trial tests

NA trial testing Guided internet-based cognitive behavioural therapy in Anxiety in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 October 2021

Primary endpoint
31 August 2024

30 June 2026

Quick facts

Lead sponsor	Norwegian Institute of Public Health
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,000
Start date	20 October 2021
Primary completion	31 August 2024
Estimated completion	30 June 2026
Sites	6 locations across Norway

Drugs / interventions tested

• Guided internet-based cognitive behavioural therapy
• Treatment as usual in Prompt Mental Health Care (TAU-PMHC)

Conditions studied

• Anxiety — all drugs for Anxiety →
• Mild to Moderate Depression — all drugs for Mild to Moderate Depression →

Sponsor

Norwegian Institute of Public Health

Who can join

18 and older, any sex, with Anxiety or Mild to Moderate Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Guided internet-based treatment for anxiety and depression in Norwegian primary care: a randomized non-inferiority effectiveness trial.
   Knapstad M, Smith OR. · · 2026 · PMID 41705119 · DOI 10.1016/j.invent.2026.100913