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

Conditions

• Anxiety
• Mild to Moderate Depression

Interventions

BEHAVIORAL

Guided internet-based cognitive behavioural therapy

AS-iCBT offers guided CBT intervention for anxiety and depression, each consisting of 6 modules. It is recommended for clients to complete 1 module weekly. The structure and content of the programme modules follow evidence-based CBT principles, and comprises cognitive and behavioural components such as self-monitoring, gradual stimulus control, exposure, behavioural activation, and cognitive restructuring. It is recommended that therapist support is provided weekly during short sessions that focus on progress monitoring and feedback on completed work. Support sessions should last 15-20 minutes and are preferably delivered by phone or video conference.

BEHAVIORAL

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

TAU-PMHC includes both low-intensity (guided self-help, group-based psychoeducation) and high-intensity CBT (F2F-CBT). The TAU-PMHC condition basically represents how PMHC services currently operates (i.e. a pragmatic stepped care model) and provides therapists with more flexibility to accommodate client needs and preferences.

Sponsors & Collaborators

• Norwegian Directorate of Health

  collaborator OTHER_GOV

• University of Bergen

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• University of Tromso

  collaborator OTHER

• Sussex Partnership NHS Foundation Trust

  collaborator OTHER

• Norwegian Institute of Public Health

  lead OTHER_GOV

Principal Investigators

• Robert Smith, PhD · Norwegian Institute of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-20

Primary Completion

2024-08-31

Completion

2026-06-30

Countries

• Norway

Study Locations