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NCT Number: NCT05118828

Guided Internet-based Interventions in Primary Care 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mild to Moderate Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PMHC Fosen, Brekstad, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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 depression as measured by respectively the Patient Health Questionnaire (PHQ). Scores from 0 to 27, higher scores indicate worse outcome.

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

    Time frame: Baseline to 24-month 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.

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

    Time frame: Baseline to 24-month 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.

  4. Work Participation based on questionnaire data

    Time frame: Baseline to 24-month follow-up

    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.

  5. Work Participation based on registry data

    Time frame: Baseline to 24-month follow-up

    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.

  6. Health-related quality of life

    Time frame: Baseline to 24-month follow-up

    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.

  7. Mental well-being

    Time frame: Baseline to 24-month follow-up

    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.

  8. Insomnia

    Time frame: Baseline to 24-month follow-up

    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).

  9. Specific anxiety measure: social anxiety disorder

    Time frame: Baseline to 24-month follow-up

    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.

  10. Specific anxiety measure: panic disorder

    Time frame: Baseline to 24-month follow-up

    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.

  11. Physical activity

    Time frame: Baseline to 24-month follow-up

    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.

  12. Sedentary behaviour

    Time frame: Baseline to 24-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • Göteborg University
  • Norwegian Directorate of Health
  • Sussex Partnership NHS Foundation Trust
  • University of Bergen
  • University of Tromso

Registry information

Official study title

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

Acronym: INTERMENTAL

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 12, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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