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

• 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

• Changes in mean levels of depression [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 [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

• 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 depression as measured by respectively the Patient Health Questionnaire (PHQ). Scores from 0 to 27, higher scores indicate worse outcome.
• Changes in mean levels of anxiety at 12-, 18- and 24-months follow-up [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.
• Recovery rate at 6-, 12-, 18-, and 24-months follow-up [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.
• Work Participation based on questionnaire data [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.
• Work Participation based on registry data [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.
• Health-related quality of life [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.
• Mental well-being [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.
• Insomnia [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).
• Specific anxiety measure: social anxiety disorder [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.
• Specific anxiety measure: panic disorder [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.
• Physical activity [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.
• Sedentary behaviour [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.

Sex: All, ages: 18 Years to any

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.

• Robert Smith, PhD, Principal investigator, Norwegian Institute of Public Health