NCT07349550

Brief Summary

Depression and anxiety affects levels of function across different levels like work, increasing levels of sick leave and as well as cognitive functioning. In the current study patients at risk of sick leave with depression and anxiety receive metacognitive therapy and work focus in an ordinary outpatient clinic. Impaired cognitive functioning may also be of importance in the return to work process and degree of sick leave. It is important to get a better understanding of how cognitive functioning is related to sick leave and if it predicts return to work, and if cognitive functioning is changed due to psychological treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Jan 2024Aug 2032

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2032

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

June 17, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Metacognitive therapyWork focusDepressionAnxietySick leave

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    Measure of depressive symptoms (PHQ-9) range 0-27 higher scores indicate higher degree of depressive symptoms

    Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up

  • Generalized Anxiety Disorder (GAD-7)

    Anxiety symptoms (GAD-7) range 0-21 higher scores indicating higher degree of anxiety symptoms

    Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up

  • Changes in sick leave

    Sick leave is collected from national register data measured in number of days of sick leave.

    Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up

Study Arms (1)

Patients referred with depression and/or anxiety and at risk of sick leave

Patients referred with depression and/or anxiety and at risk of sick leave

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred with depression and/or anxiety disorders at risk of sick leave.

You may qualify if:

  • diagnosis of depression and/or anxiety,
  • at risk of sick leave

You may not qualify if:

  • personality disorders cluster A or B,
  • ongoing substance abuse,
  • symptoms of psychosis,
  • acute suicidality,
  • serious somatic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Odin Hjemdal, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

January 20, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2032

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Due to ethical considerations as this is a clinical study that includes patients with depression and/or anxiety at risk of sick leave, information will not be shared

Locations