NCT03343457

Brief Summary

Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable anxiety

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

October 30, 2017

Last Update Submit

November 15, 2017

Conditions

Keywords

AnxietyChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Return to work (RTW)

    Return to work measured as self-reported change in working hours

    One year

Study Arms (3)

Acceptance Commitment Therapy

EXPERIMENTAL

Acceptance Commitment Therapy. Cognitive therapy

Behavioral: Cognitive therapy

Multidisciplinary assessment

EXPERIMENTAL

Assessment of a team. Cognitive therapy

Behavioral: Cognitive therapy

Control

NO INTERVENTION

Control group

Interventions

Also known as: ACT, multidisciplinary assessment
Acceptance Commitment TherapyMultidisciplinary assessment

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • On sick leave for mental illness and/or chronic pain

You may not qualify if:

  • High risk for suicide
  • Ongoing alcohol/substance abuse
  • Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
  • Participation in psychotherapy or another vocational rehabilitation program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Berglund E, Anderzen I, Helgesson M, Lytsy P, Andersen A. Work participation after receiving multidisciplinary treatment or acceptance and commitment therapy intervention for return to work: long-term follow-up of a randomized controlled trial among sick-listed individuals with mental disorders and/or chronic pain. BMC Public Health. 2024 Dec 21;24(1):3558. doi: 10.1186/s12889-024-21116-1.

MeSH Terms

Conditions

Anxiety DisordersChronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 17, 2017

Study Start

January 1, 2010

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

November 17, 2017

Record last verified: 2017-11