AnxietyINTERMENTALNCT05118828
Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial
A study testing Guided internet-based cognitive behavioural therapy and Treatment as usual in Prompt Mental Health Care (TAU-PMHC) in people with Anxiety and Mild to Moderate Depression, run by Norwegian Institute of Public Health at 6 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Mild to Moderate Depression
- What is being tested?
- Guided internet-based cognitive behavioural therapy and Treatment as usual in Prompt Mental Health Care (TAU-PMHC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesNorway
- Study dates
- 20 Oct 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
PMHC Fosen
Brekstad
PMHC Karmøy
Kopervik
PMHC Vestvågøy
Leknes
PMHC Notodden
Notodden
PMHC Sandnes
Sandnes
PMHC Modum
Vikersund
About this study
Official title: Guided Internet-based Interventions in Primary Care: the INTERMENTAL Effectiveness-implementation Randomized Controlled Trial
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.
Read more
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
- Being tested
- Guided internet-based cognitive behavioural therapy, Treatment as usual in Prompt Mental Health Care (TAU-PMHC)
- Keywords
- Anxiety, Depression, Guided internet-based interventions, CBT, Outcome monitoring, Dissemination, Routine services
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided internet-based cognitive behavioural therapyBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided internet-based treatment (AS-iCBT) | Experimental | Not described Receives: Behavioral: Guided internet-based cognitive behavioural therapy |
| Treatment as usual in Prompt Mental Health Care (TAU-PMHC) | Active comparator | Not described Receives: Behavioral: Treatment as usual in Prompt Mental Health Care (TAU-PMHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6-month follow-up
Secondary outcomes (12)
Changes in mean levels of depression at 12-, 18- and 24-months follow-up
Changes in mean levels of depression as measured by respectively the Patient Health Questionnaire (PHQ). Scores from 0 to 27, higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Changes in mean levels of anxiety at 12-, 18- and 24-months follow-up
Changes in mean levels of anxiety as measured by respectively the Generalized Anxiety Disorder scale (GAD). Scores from 0 to 21, higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Recovery rate at 6-, 12-, 18-, and 24-months follow-up
Proportion of clients that have recovered based on pre-defined cut-offs for PHQ and GAD. Cut-off for PHQ is >= 10 and for GAD >=8.
Measured: Baseline to 24-month follow-up
Work Participation based on questionnaire data
Increased or maintained work participation at 6-, 12-, 18-, and 24-months follow-up, defined as maintained work participation, new employment or a full or partial return-to-work.
Measured: Baseline to 24-month follow-up
Work Participation based on registry data
Increased or maintained work participation at 6-, 12-, 18-, and 24-months follow-up, defined as maintained work participation, new employment or a full or partial return-to-work.
Measured: Baseline to 24-month follow-up
Health-related quality of life
Changes in mean levels of health-related QoL as measured by EuroQol-5D-5L at 6-, 12-, 18-, and 24-months follow-up. Scores from 5 to 25. Higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Mental well-being
Changes in mean levels of mental well-being as measured by the 7-item short Warwick Edinburgh Mental Well-Being Scale (sWEMWBS) at 6-, 12-, 18-, and 24-months follow-up. Scores from 7 to 35. Lower scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Insomnia
Recovery from insomnia as assessed by a proxy for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) insomnia diagnosis at 6-, 12-, 18-, and 24-months follow-up. The proxy measure is derived from a revised version of the Bergen Insomnia Scale (BIS).
Measured: Baseline to 24-month follow-up
Specific anxiety measure: social anxiety disorder
Changes in mean levels of symptoms of social anxiety disorder as measured by the Social Phobia Inventory (SPIN-9) at 6-, 12-, 18-, and 24-months follow-up. Scores from 9 to 45. Higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Specific anxiety measure: panic disorder
Changes in mean levels of symptoms of panic disorder as measures by the Panic Disorder Screener (PADIS) at 6-, 12-, 18-, and 24-months follow-up. Scores from 0 to 13. Higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Physical activity
Changes in mean levels of physical activity at 6-, 12-, 18-, and 24-months follow-up. Physical activity will be assessed using three sets of questions, assessing the average number of times exercising each week, and the average intensity and average hours each time. This 3-item questionnaire has previously been used in the large population-based Nord-Trøndelag Health Study (the HUNT studies). A physical activity index will be derived in line with the work from Kurtze et al. (2008). Scores from 0 to 15. Lower scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Sedentary behaviour
Changes in mean levels of sedentary behaviour (SB) at 6-, 12-, 18-, and 24-months follow-up. Sedentary behaviour was assessed using two questions assessing the average number of hours of sedentary behaviour during the last two weeks. The first questions covers sedentary behaviour during weekdays, whereas the second question covers sedentary behaviour during the weekend. A weighted sum score of these items is used to derive an index for SB. The items are based on the single item on SB in the short form of the international physical activity questionnaire (IPAQ-SF). Scores from 0 to 5. Higher scores indicate worse outcome.
Measured: Baseline to 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start20 Oct 2021
- Primary completion31 Aug 2024
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian Directorate of Health, University of Bergen, Göteborg University, University of Tromso, Sussex Partnership NHS Foundation Trust
- Responsible party
- Principal investigator, Robert Smith, Norwegian Institute of Public Health
- Investigators
- Robert Smith, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118828
- Sponsor's protocol ID
- 20-397
- Acronym
- INTERMENTAL
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-based Interventions in Primary Care: the INTERMENTAL Effectiveness-implementation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05118828
- Acronym / sponsor ID
- INTERMENTAL / 20-397
- Conditions
- Anxiety, Mild to Moderate Depression
- Keywords
- Anxiety, Depression, Guided internet-based interventions, CBT, Outcome monitoring, Dissemination, Routine services
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian Directorate of Health, University of Bergen, Göteborg University, University of Tromso, Sussex Partnership NHS Foundation Trust
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided internet-based cognitive behavioural therapyAS-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. | Behavioural | Guided internet-based treatment (AS-iCBT) |
| 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. | Behavioural | Treatment as usual in Prompt Mental Health Care (TAU-PMHC) |
Primary outcome
Changes in mean levels of depression
Time frame: Baseline to 6-month follow-up
Changes in mean levels of depression as measured by the Patient Health Questionnaire (PHQ). Scores from 0 to 27, higher scores indicate worse outcome.
Changes in mean levels of anxiety
Time frame: Baseline to 6-month follow-up
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.
12 secondary outcomes
Changes in mean levels of depression at 12-, 18- and 24-months follow-up
Time frame: Baseline to 24-month follow-up
Changes in mean levels of anxiety at 12-, 18- and 24-months follow-up
Time frame: Baseline to 24-month follow-up
Recovery rate at 6-, 12-, 18-, and 24-months follow-up
Time frame: Baseline to 24-month follow-up
Work Participation based on questionnaire data
Time frame: Baseline to 24-month follow-up
Work Participation based on registry data
Time frame: Baseline to 24-month follow-up
Health-related quality of life
Time frame: Baseline to 24-month follow-up
Mental well-being
Time frame: Baseline to 24-month follow-up
Insomnia
Time frame: Baseline to 24-month follow-up
Specific anxiety measure: social anxiety disorder
Time frame: Baseline to 24-month follow-up
Specific anxiety measure: panic disorder
Time frame: Baseline to 24-month follow-up
Physical activity
Time frame: Baseline to 24-month follow-up
Sedentary behaviour
Time frame: Baseline to 24-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Smith, PhD principal investigator
Norwegian Institute of Public Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided internet-based cognitive behavioural therapy and Treatment as usual in Prompt Mental Health Care (TAU-PMHC) in people with Anxiety and Mild to Moderate Depression, run by Norwegian Institute of Public Health at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean levels of depression (time frame: Baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.