Sherpa- An Early Supported Employment Intervention for Individuals With Affective Disorders or Anxiety Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Mental Health Centre Copenhagen
Sponsor:
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier:
NCT01721824
First received: October 24, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The aim of the present study, is to evaluate the effect of the Sherpa method (a supported employment intervention) on employment or education, when given to people with onset affective disorders or anxiety disorders who are not likely to be able to return to work within three month.

The hypothesis is that the Sherpa method is associated with a shorter recovery period and more people returning to work or education, compared to treatment as usual.


Condition Intervention
Affective Disorder
Major Depressive Disorder
Bipolar Disorder
Anxiety Disorder
Behavioral: The Sherpa method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Sherpa- A Randomized Clinical Trial Examining the Effect of an Early Supported Employment Intervention in Addition to Treatment as Usual Versus Treatment as Usual Alone for Individuals With Affective Disorders or Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Mental Health Centre Copenhagen:

Primary Outcome Measures:
  • Competitive employment or education [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy job. Information on employment and education will be extracted from the DREAM database. This database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.


Secondary Outcome Measures:
  • Competitive employment or studying [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy jobs. Information on employment and education will be extracted from the DREAM database. The database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.

  • Number of days of competitive employment or studying [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Information will be obtained from the Dream database.

  • Changing from matchgroup 2 or 3 to matchgroup 1 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    If participants are matchgroup 2 or 3, they are not able to go back to work within the following 3 months. If participants are matchgroup 1, they should be actively seeking jobs.

  • Hamilton Rating Scale for Depression - 6 items [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for anxiety -6 item scale [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • The Bech-Rafaelsen Mania Scale (MAS) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Suicidal ideations [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Suicidal ideations are measured by a validated scale distinguishing between ideations, thougths, plans and actual suicidal attempts.

  • Global Assessment of Function [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Personal and Social Performance [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • WHO-5 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • The Empowerment Scale [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 434
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sherpa

The Sherpa method consists of five basic services for the participants. 1)Individual mentor support, based on psychiatric knowledge. 2)Coordination by the Sherpa-mentor of activities provided by Sherpa but also by external providers. 3)Career counseling aimed at people with mental illnesses. 4)Impartial help to clarify private economy. 5) Contact to employers to help participants obtain jobs, and keep them.

Participants will receive the Sherpa method in addition to treatment as usual.

Behavioral: The Sherpa method
During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the Sherpa intervention is 12 months, but since the needs of the participants are very individual, this may vary.
No Intervention: Control group
Participants randomised to the control group will receive "treatment as usual" only. This means the standard support offered by the social- and health services in Denmark.

Detailed Description:

Background: The Sherpa method is a modified Individual Placement and Support (IPS) intervention, aiming at supporting people with affective disorders or anxiety disorders regain their workability and return to work or education. Previous studies have showed, that IPS has an effect on employment when offered to people with severe mental illness. Further studies are crucial to demonstrate whether the modified IPS, the Sherpa method, has an effect when offered to people with affective disorders or anxiety disorders who are not yet chronified.

Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the Sherpa method in addition to treatment as usual compared to treatment as usual alone for 434 participants diagnosed with an affective disorder or anxiety disorder, living in the Capital Region of Denmark. The primary outcome is competitive employment or education. Secondary outcomes are days of competitive employment or education, disease symptoms, level of functioning, quality of life, empowerment, number and duration of hospital admissions and out-patient treatment at follow-up 12 and 24 months after baseline.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed following the International Classification of Diseases (ICD-10) criteria of affective disorder (F30-39) or anxiety disorder (F40-41)
  • Not able to work within 3 months
  • Associated with the Mental Health Center Copenhagen, Frederiksberg, Hillerød, Hvidovre or Ballerup
  • Only having had contact to the Mental Health services during the past 3 years
  • Having had competitive employment or attending a study within the past two years.
  • Has returning to work or education as an important goal
  • Under the age of 60
  • Able to speak, read and understand danish
  • Has given informed consent verbally and in writing

Exclusion Criteria:

  • A somatic disease that effects the workability
  • Substance og alcohol abuse
  • have a guardian or a forensic psychiatric arrangement
  • not given informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721824

Contacts
Contact: Lene Falgaard Eplov, MD, PhD +45 38647461 Lene.Falgaard.Eplov@regionh.dk
Contact: Lone Hellström, MSc +45 23836038 lone.hellstroem@regionh.dk

Locations
Denmark
Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland Recruiting
Ballerup, Denmark, 2750
Contact: Lone Hellström, MSc    +45 23836038    lone.hellstroem@regionh.dk   
Contact: Lene F Eplov, MD, PhD    +45 38647461    Lene.Falgaard.Eplov@regionh.dk   
Principal Investigator: Lone Hellström, MSc         
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
Principal Investigator: Lene F Eplov, MD, PhD Mental Health Center Copenhagen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lene Falgaard Eplov, Senior consultant, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT01721824     History of Changes
Other Study ID Numbers: H-2-2011-FSP20
Study First Received: October 24, 2012
Last Updated: November 5, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Mental Health Centre Copenhagen:
Supported employment
Individual Placement and Support
Workability
Return to work

Additional relevant MeSH terms:
Mood Disorders
Affective Disorders, Psychotic
Anxiety Disorders
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Mental Disorders
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014