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

How Does Education of Health Personnel With Acceptance and Commitment Therapy Affect the Extent of Medical Certificates of Sick Leave and Drug Prescriptions?

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?

Study Overview

• Status: Completed
• Conditions: Medical Certificates for Sick Leave and Drug Prescriptions
• Intervention / Treatment: Behavioral: Education with Acceptance and Commitment Therapy; Other: Control, no intervention

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 Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden, 58185
    • University Hospital of Linkoping
  • Sverige
    • Linköping, Sverige, Sweden, 60580
      • Faculty of Medicine and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of medical certificates of sick leave by the doctors	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.	24 months in total
Prescription of drugs by the doctors	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.	24 months in total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of how the education with ACT affect the personnel according to SF36	Questionnaire SF36 is filled out by the personnel at baseline and after 12 months	12 months
Assessment of how the education with ACT affect the personnel according to KEDS	Questionnaire Karolinska Exhaustion Disorder Scale (KEDS) is filled out by the personnel at baseline and after 12 months	12 months
Assessment of how the education with ACT affect the personnel according to WAI	Questionnaire Work ability Index (WAI) is filled out by the personnel at baseline and after 12 months	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: County Councils of Region Östergötland, Kalmar and Jönköping
• Investigators: Principal Investigator: Fredrik H Nyström, MD, prof., Region Östergötland, Sweden; Principal Investigator: Fredrik Nyström, MD, Linköping University, Sweden

Publications and helpful links

General Publications

• Kadowaki A, Alvunger AK, Larsen HI, Persdotter A, Zak MS, Johansson P, Nystrom FH. Education of the primary health care staff based on acceptance and commitment therapy is associated with reduced sick leave in a prospective controlled trial. BMC Fam Pract. 2021 Sep 8;22(1):179. doi: 10.1186/s12875-021-01526-5.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018/323-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No