Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial
NCT ID: NCT05118828
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2021-10-20
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Guided internet-based treatment (AS-iCBT)
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.
Treatment as usual in Prompt Mental Health Care (TAU-PMHC)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Norwegian Directorate of Health
OTHER_GOV
University of Bergen
OTHER
Göteborg University
OTHER
University of Tromso
OTHER
Sussex Partnership NHS Foundation Trust
OTHER
Norwegian Institute of Public Health
OTHER_GOV
Responsible Party
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Robert Smith
Research Professor
Principal Investigators
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Robert Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian Institute of Public Health
Locations
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PMHC Fosen
Brekstad, , Norway
PMHC Karmøy
Kopervik, , Norway
PMHC Vestvågøy
Leknes, , Norway
PMHC Notodden
Notodden, , Norway
PMHC Sandnes
Sandnes, , Norway
PMHC Modum
Vikersund, , Norway
Countries
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Other Identifiers
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20-397
Identifier Type: -
Identifier Source: org_study_id