ACTPrimary: Effects of Acceptance and Commitment Therapy in Primary Health Care

• Sponsor: University Hospital, Linkoeping (Other)
• Overall Status: Completed
• CT.gov ID: NCT03737019
• Collaborator: County Councils of Region Östergötland, Kalmar and Jönköping (Other)
• Enrollment: 700
• Locations: 2
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site: 350
• Patients Per Site Per Month: 10.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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 interventionProspective 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: Oct 31, 2018
• Actual Primary Completion Date: Oct 5, 2020
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Extent of medical certificates of sick leave by the doctors [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 [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 [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 [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 [12 months]

   Questionnaire Work ability Index (WAI) is filled out by the personnel at baseline and after 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine and Health Sciences	Linköping	Sverige	Sweden	60580
2	University Hospital of Linkoping	Linkoping		Sweden	58185

Sponsors and Collaborators

• University Hospital, Linkoeping
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Nov 9, 2018
• Last Update Posted: Oct 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 4, 2021