eBehandling - Health and Work for Patients in Specialist Mental Health Care
NCT Number: NCT06568419
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Depression
Interventions: BEHAVIORAL: Transdiagnostic, work-focused Cognitive Behavioural Therapy
Sponsor: Solli Distriktspsykiatriske Senter
Collaborators: Sykehuset Innlandet HF|Sykehuset Ostfold|Sykehuset i Vestfold HF|University Hospital, Aker|Helse Fonna HF|Helse Bergen Hospital Trust|Vestre Viken Hospital Trust|Macquarie University, Australia|Diakonhjemmet Hospital|Haukeland University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2028-08
Locations: Sykehuset Vestre Viken, Oslo, Bærum, 1346, Norway|Sykehuset Innlandet, Lillehammer, Innlandet, 2609, Norway|Sykehuset i Vestfold, Tønsberg, Vestfold, 3103, Norway|University of Bergen, Bergen, Vestland, 5007, Norway|Bjørgvin DPS (Helse Bergen), Bergen, Vestland, 5113, Norway|Solli DPS, Bergen, Vestland, 5227, Norway|Vinderen DPS, Oslo, 0373, Norway|AHus DPS Grorudalen, Oslo, 1067, Norway|Sykehuset i Østfold, Fredrikstad, Østfold, 1603, Norway

Summary:
Mental health problems and disorders affect one in every five amongst the working- age adults in the countries of the Organization for Economic Cooperation and Development. This constitutes a major public health challenge that also has large implications for work participation and productivity.

Major depression and anxiety are the most prevalent of the mental disorders and are therefore named common mental disorders (CMD). CMD have become a major cause of work absenteeism, with 30% of all sick leave in Norway being due to CMDs in 2024.

Early interventions addressing psychological aspects and vocational challenges related to work have shown a positive effect on return to work. Therefore, finding ways to increase availability and reduce barriers to evidence-based treatments seems a viable route to reducing mental health's impact on sick leave and absenteeism.

Research show that improvement in symptoms from ordinary psychotherapy has little impact on sick-leave. The same results have been found for internet-based cognitive therapy (ICBT). One of the challenges in specialised mental health care is that the work focus has been an additive or extended part of the treatment, not integrated in the treatment itself.

Several studies have been conducted on psychological treatments that specifically target return to work for people with CMDs. Systematic reviews have shown that work-focused therapy has a small, but significant effect over treatment as usual on return to work and finds that 20% more workers in the intervention groups had returned to work, compared to control groups.

The availability of traditional therapy is scarce and there is an need for new effective ways of delivery. internet-based cognitive therapy has been shown to be as effective as traditional therapy in many systematic reviews and meta analysis and seems a good approach to reach the goal of increasing availability.

To account for the heterogene group of people on sick leave the investigators have created a transdiagnostic, work-focused internet-based cognitive behaviloural therapy program.

This study aims is to is to investigate the utility and use of this treatment program for patients with common mental health disorders on sick leave or work assessment allowance. This includes the user experience of participation and experienced utility of the treatment program.

Primary Outcome Measures: Degree of Sickleave, Self-reported degree of sick leave (percentage), baseline, 6 weeks, 12 weeks, 6 months and 12 months|Return to Work Self-efficacy 11, 11-item questionnaire measuring an individual's confidence in their ability to work and perform work tasks. Items are scored on a scale from 1 ("Totally disagree") to 6 ("Totally agree"). Items 2 and 6 are reversed., baseline, 6 weeks, 12 weeks, 6 months and 12 months
Secondary Outcome Measures: Generalized Anxiety Disorder-7, measure of worry and anxiety and consists of seven items scored from 0 ("Not at all") to 3 ("Nearly every day") and one additional item measuring how the symptoms affect functioning., baseline, 6 weeks, 12 weeks, 6 months and 12 months|Patient Health Questionnaire-9, measures depression severity. The measure consists of nine items scored from 0 ("Not at all") to 3 ("Nearly every day")., baseline, 6 weeks, 12 weeks, 6 months and 12 months|The Work and Social Adjustment Scale, measures impairment in functioning. The measure consists of five items scored from 0 (not at all impaired) to 8 (very severely impaired), baseline, 6 weeks, 12 weeks, 6 months and 12 months|CORE-OM, a 34-item self-report, measuring well-being, symptoms, elements of risk, and function on a five-point scale ranging from "not at all" to "most, or all the time"., baseline, 6 weeks, 12 weeks, 6 months and 12 months|CORE-10, a ten item self-report measuring symptoms, well-being, functioning and risk on a five-point scale ranging from "not at all" to "most, or all the time", at 2, 4, 8 and 10 weeks|The Negative Effects Questionnaire, a 20-item questionnaire evaluating adverse or unwanted events during treatment. Participants report whether a specific event occurred during treatment ("Yes"/"No") and then indicate how negatively they were affected by it on a scale ranging from 0-4., at 12 weeks
Other Outcome Measures: Credibility Rating Scale, An adapted version of the Credibility Rating Scale (Borkovec \& Nau 1972) will be used to assess treatment credibility. The scale consists of five items where participants rate their credibility/expectancy-for-improvement on a 10-point scale., baseline, 6 weeks and 12 weeks|Montgomery and Åsberg Depression Rating Scale, Participants will each week answer question 10 (suicidal ideations), baseline and every week for 12 weeks (until the end of the treatment program)