Clinical trial NCT05118828: Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial
Official title: Guided Internet-based Interventions in Primary Care: the INTERMENTAL Effectiveness-implementation Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Mild to Moderate Depression
Keywords: Anxiety
Depression
Guided internet-based interventions
CBT
Outcome monitoring
Dissemination
Routine services
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian Directorate of Health
name: University of Bergen
name: Göteborg University
name: University of Tromso
name: Sussex Partnership NHS Foundation Trust
First posted: 2021-11-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in mean levels of depression
timeFrame: Baseline to 6-month follow-up
measure: Changes in mean levels of anxiety
timeFrame: Baseline to 6-month follow-up
Secondary outcomes:
measure: Changes in mean levels of depression at 12-, 18- and 24-months follow-up
timeFrame: Baseline to 24-month follow-up
measure: Changes in mean levels of anxiety at 12-, 18- and 24-months follow-up
timeFrame: Baseline to 24-month follow-up
measure: Recovery rate at 6-, 12-, 18-, and 24-months follow-up
timeFrame: Baseline to 24-month follow-up
measure: Work Participation based on questionnaire data
timeFrame: Baseline to 24-month follow-up
measure: Work Participation based on registry data
timeFrame: Baseline to 24-month follow-up
measure: Health-related quality of life
timeFrame: Baseline to 24-month follow-up
measure: Mental well-being
timeFrame: Baseline to 24-month follow-up
measure: Insomnia
timeFrame: Baseline to 24-month follow-up
measure: Specific anxiety measure: social anxiety disorder
timeFrame: Baseline to 24-month follow-up
measure: Specific anxiety measure: panic disorder
timeFrame: Baseline to 24-month follow-up
measure: Physical activity
timeFrame: Baseline to 24-month follow-up
measure: Sedentary behaviour
timeFrame: Baseline to 24-month follow-up
Other outcomes:
Locations:
city: Brekstad
country: Norway
facility: PMHC Fosen
city: Kopervik
country: Norway
facility: PMHC Karmøy
city: Leknes
country: Norway
facility: PMHC Vestvågøy
city: Notodden
country: Norway
facility: PMHC Notodden
city: Sandnes
country: Norway
facility: PMHC Sandnes
city: Vikersund
country: Norway
facility: PMHC Modum
Study officials:
affiliation: Norwegian Institute of Public Health
name: Robert Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: