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

Norwegian Institute of Public Health

Status

Active, not recruiting

Conditions

Anxiety

Mild to Moderate Depression

Treatments

Behavioral: Guided internet-based cognitive behavioural therapy

Behavioral: Treatment as usual in Prompt Mental Health Care (TAU-PMHC)

Study type

Interventional

Funder types

Other

Identifiers

NCT05118828

20-397

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Presence of anxiety and/or mild to moderate depression.
Being above 18 years of age and a resident in the pilot sites.
Basic verbal and oral Norwegian proficiency.
Having internet access and ability to use it.

Exclusion criteria

Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, psychotic symptoms, severe substance abuse, and/or personality disorder.
Two or more previous treatment attempts in secondary care services without effect.
Serious physical health problem as primary problem.
Clients that have had treatment at PMHC before and only require a booster session.