eBehandling - Health and Work for Patients in Specialist Mental Health Care

NCT06568419 | Recruiting

• 1 other identifier: 733956
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

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.

Conditions

Anxiety; Depression

Keywords

Sick Leave; Absemteeism; Transdiagnostic treatment; Internet-based Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Generalized Anxiety Disorder-7

  baseline, 6 weeks, 12 weeks, 6 months and 12 months

• Patient Health Questionnaire-9

  baseline, 6 weeks, 12 weeks, 6 months and 12 months

• The Work and Social Adjustment Scale

  baseline, 6 weeks, 12 weeks, 6 months and 12 months

• CORE-OM

  baseline, 6 weeks, 12 weeks, 6 months and 12 months

• CORE-10

  at 2, 4, 8 and 10 weeks

Other Outcomes (2)

• Credibility Rating Scale

  baseline, 6 weeks and 12 weeks

• Montgomery and Åsberg Depression Rating Scale

  baseline and every week for 12 weeks (until the end of the treatment program)

Study Arms (1)

Digital transdiagnostic work-focused CBT treatment program

EXPERIMENTAL

digital transdiagnostic work-focused CBT treatment program for patients with common mental health disorders on sick leave or work assessment allowance

Behavioral: Transdiagnostic, work-focused Cognitive Behavioural Therapy

Interventions

Transdiagnostic, work-focused Cognitive Behavioural Therapy BEHAVIORAL

Transdiagnostic, work-focused Cognitive Behavioural Therapy focuses on core mechanisms that creates and maintain illness in depression and anxiety. Namely reducing avoidance and/or suppression of unwanted thoughts, avoidance of meaningful activity and increase cognitive flexibility while under psychological stress.

Digital transdiagnostic work-focused CBT treatment program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being an outpatient in specialised mental health care service,
• above 18 years old,
• full or graded sick leave, or on work assessment allowance
• primary diagnosis of F30 - F40 (ICD-10),
• currently employed.

You may not qualify if:

• ongoing psychotic disorder and/or mania,
• ongoing substance abuse, incl. sedative medications,
• ongoing episode of major depression,
• organic brain disease,
• severe reading and writing difficulties.

Sponsors & Collaborators

• Solli Distriktspsykiatriske Senter: lead
• Sykehuset Innlandet HF: collaborator
• Sykehuset Ostfold: collaborator
• Sykehuset i Vestfold HF: collaborator
• University Hospital, Aker: collaborator
• Helse Fonna: collaborator
• Helse Bergen Hospital Trust: collaborator
• Vestre Viken Hospital Trust: collaborator
• Macquarie University, Australia: collaborator
• Diakonhjemmet Hospital: collaborator
• Haukeland University Hospital: collaborator

Study Sites (9)

Sykehuset Vestre Viken

Oslo, Bærum, 1346, Norway

RECRUITING

Sykehuset Innlandet

Lillehammer, Innlandet, 2609, Norway

RECRUITING

Vinderen DPS

Oslo, Oslo, 0373, Norway

NOT YET RECRUITING

AHus DPS Grorudalen

Oslo, Oslo, 1067, Norway

NOT YET RECRUITING

Sykehuset i Vestfold

Tønsberg, Vestfold, 3103, Norway

RECRUITING

University of Bergen

Bergen, Vestland, 5007, Norway

ACTIVE NOT RECRUITING

Bjørgvin DPS (Helse Bergen)

Bergen, Vestland, 5113, Norway

NOT YET RECRUITING

Solli DPS

Bergen, Vestland, 5227, Norway

NOT YET RECRUITING

Sykehuset i Østfold

Fredrikstad, Østfold fylke, 1603, Norway

NOT YET RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Pål William Wallace, PhD

  Solli DPS

  STUDY DIRECTOR

• Kristine Sirevåg, MSc

  Solli DPS

  STUDY CHAIR

Central Study Contacts

Henning Monsen, MSc

CONTACT

0047+47018243; henning.monsen@Solli.no

Pål William Wallace, PhD

CONTACT

004745356200; pal.wiliam.wallace@solli.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a non-randomized, single arm, multi-center mixed methods clinical trial in a naturalistic setting

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 23, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)