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

NCT05118828 | Active Not Recruiting

• 1 other identifier: 20-397
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Anxiety; Depression; Guided internet-based interventions; CBT; Outcome monitoring; Dissemination; Routine services

Outcome Measures

Primary Outcomes (2)

• Changes in mean levels of depression

  Changes in mean levels of depression as measured by the Patient Health Questionnaire (PHQ). Scores from 0 to 27, higher scores indicate worse outcome.

  Baseline to 6-month follow-up

• Changes in mean levels of anxiety

  Changes in mean levels of anxiety as measured by the Generalized Anxiety Disorder scale (GAD). Scores from 0 to 21, higher scores indicate worse outcome.

  Baseline to 6-month follow-up

Secondary Outcomes (12)

• Changes in mean levels of depression at 12-, 18- and 24-months follow-up

  Baseline to 24-month follow-up

• Changes in mean levels of anxiety at 12-, 18- and 24-months follow-up

  Baseline to 24-month follow-up

• Recovery rate at 6-, 12-, 18-, and 24-months follow-up

  Baseline to 24-month follow-up

• Work Participation based on questionnaire data

  Baseline to 24-month follow-up

• Work Participation based on registry data

  Baseline to 24-month follow-up

Study Arms (2)

Guided internet-based treatment (AS-iCBT)

EXPERIMENTAL

Behavioral: Guided internet-based cognitive behavioural therapy

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

ACTIVE COMPARATOR

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

Interventions

Guided internet-based cognitive behavioural therapy BEHAVIORAL

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.

Guided internet-based treatment (AS-iCBT)

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Norwegian Directorate of Health: collaborator
• University of Bergen: collaborator
• Göteborg University: collaborator
• University of Tromso: collaborator
• Sussex Partnership NHS Foundation Trust: collaborator

Study Sites (6)

PMHC Fosen

Brekstad, Norway

Location

PMHC Karmøy

Kopervik, Norway

Location

PMHC Vestvågøy

Leknes, Norway

Location

PMHC Notodden

Notodden, Norway

Location

PMHC Sandnes

Sandnes, Norway

Location

PMHC Modum

Vikersund, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Robert Smith, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 12, 2021
• Study Start: October 20, 2021
• Primary Completion: August 31, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)