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Effects of Acceptance and Commitment Therapy in Primary Health Care (ACTPrimary)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03737019
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
County Councils of Region Östergötland, Kalmar and Jönköping
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

Study Description
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Brief Summary:
How does education of health personnel with Acceptance and Commitment Therapy affect the extent of medical certificates of sick leave and drug prescriptions in primary health care centers in Kalmar compared with similar centers in Jönköping in which the personnel do not get such therapy?

Condition or disease Intervention/treatment Phase
Medical Certificates for Sick Leave and Drug Prescriptions Behavioral: Education with Acceptance and Commitment Therapy Other: Control, no intervention Not Applicable

Detailed Description:
Five primary health care centers in the County Council of Jönköping who do not get education according to Acceptance and Commitment Therapy (ACT) serve as controls. Six primary health care centers in County Council of Kalmar, with the same total number of listed patients (about 45 000 in total per County Council) in their areas undergo group education according to ACT. Data on medical certificates of sick leave and drug prescriptions are taken from registries (this is routine in primary health care in Sweden) at baseline and after 6, 12 and 24 months in both regions. The personnel at both centers also fill out questionnaires about their own quality of life at baseline and after 12 months. The investigators also plan to interview about 20 subjects on these matters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective non-randomized trial with one interventional group and a parallel group without intervention
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: How Does Education of Health Personnel With Acceptance and Commitment Therapy Affect the Extent of Medical Certificates of Sick Leave and Drug Prescriptions?
Actual Study Start Date : October 31, 2018
Actual Primary Completion Date : October 5, 2020
Actual Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: ACT in County Council of Kalmar
Group education with ACT in six primary health care centers in County Council of Kalmar
 Behavioral: Education with Acceptance and Commitment Therapy
Group education with Acceptance and Commitment Therapy of the personnel at each center.
Placebo Comparator: Control health care centers of County Council of Jönköping
Five primary health care centers of County Council of Jönköping that do not get education.
 Other: Control, no intervention
Control, no interventions.


Outcome Measures
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Primary Outcome Measures :
  1. Extent of medical certificates of sick leave by the doctors [ Time Frame: 24 months in total ]
    Data on entire extent of medical certificates, i.e. how many sick days that were certified by all doctors at the primary health care centers, for all patients treated, during the time period.

  2. Prescription of drugs by the doctors [ Time Frame: 24 months in total ]
    Data on all prescription of all different drugs, during the time period, made by all the doctors at the primary Health care centers that participate, to all patients that were treated.


Secondary Outcome Measures :
  1. Assessment of how the education with ACT affect the personnel according to SF36 [ Time Frame: 12 months ]
    Questionnaire SF36 is filled out by the personnel at baseline and after 12 months

  2. Assessment of how the education with ACT affect the personnel according to KEDS [ Time Frame: 12 months ]
    Questionnaire Karolinska Exhaustion Disorder Scale (KEDS) is filled out by the personnel at baseline and after 12 months

  3. Assessment of how the education with ACT affect the personnel according to WAI [ Time Frame: 12 months ]
    Questionnaire Work ability Index (WAI) is filled out by the personnel at baseline and after 12 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • over 18 years of age
  • working at the health care center

Exclusion Criteria:

  • age less than 18 years
  • do not work at the Health care center
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737019


Locations
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Sweden
Faculty of Medicine and Health Sciences
Linköping, Sverige, Sweden, 60580
University Hospital of Linkoping
Linkoping, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping
County Councils of Region Östergötland, Kalmar and Jönköping
Investigators
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Principal Investigator: Fredrik H Nyström, MD, prof. Region Östergötland, Sweden
Principal Investigator: Fredrik Nyström, MD Linköping University, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fredrik H Nystrom, MD PhD, consultant in internal medicine, professor of internal medicine, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03737019    
Other Study ID Numbers: 2018/323-32
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No