NCT06568419 eBehandling - Health and Work for Patients in Specialist Mental Health Care
| NCT ID | NCT06568419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Solli Distriktspsykiatriske Senter |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-12-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. being an outpatient in specialised mental health care service, 2. above 18 years old, 3. full or graded sick leave, or on work assessment allowance 4. primary diagnosis of F30 - F40 (ICD-10), 5. currently employed. Exclusion Criteria: 1. ongoing psychotic disorder and/or mania, 2. ongoing substance abuse, incl. sedative medications, 3. ongoing episode of major depression, 4. organic brain disease, 5. severe reading and writing difficulties.
Contact & Investigator
Pål William Wallace, PhD
STUDY DIRECTOR
Solli DPS
Frequently Asked Questions
Who can join the NCT06568419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568419 currently recruiting?
Yes, NCT06568419 is actively recruiting participants. Contact the research team at henning.monsen@Solli.no for enrollment information.
Where is the NCT06568419 trial being conducted?
This trial is being conducted at Oslo, Norway, Lillehammer, Norway, Oslo, Norway, Oslo, Norway and 5 additional locations.
Who is sponsoring the NCT06568419 clinical trial?
NCT06568419 is sponsored by Solli Distriktspsykiatriske Senter. The principal investigator is Pål William Wallace, PhD at Solli DPS. The trial plans to enroll 400 participants.
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