Medical Certificates for Sick Leave and Drug PrescriptionsACTPrimaryNCT03737019
Effects of Acceptance and Commitment Therapy in Primary Health Care
A study testing Education with Acceptance and Commitment Therapy in people with Medical Certificates for Sick Leave and Drug Prescriptions, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Certificates for Sick Leave and Drug Prescriptions
- What is being tested?
- Education with Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 2 sitesSweden
- Study dates
- 31 Oct 2018to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age
- working at the health care center
Who cannot join
- age less than 18 years
- do not work at the Health care center
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Faculty of Medicine and Health Sciences
Linköping, Sverige, 60580
University Hospital of Linkoping
Linköping, 58185
About this study
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?
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?
Read the 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.
- Being tested
- Education with Acceptance and Commitment Therapy, Control, no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education with Acceptance and Commitment TherapyBehavioural
Group education with Acceptance and Commitment Therapy of the personnel at each center.
Control, no interventionOther
Control, no interventions.
| Study group | Role | What they receive |
|---|---|---|
| ACT in County Council of Kalmar | Experimental | Group education with ACT in six primary health care centers in County Council of Kalmar Receives: Behavioral: Education with Acceptance and Commitment Therapy |
| Control health care centers of County Council of Jönköping | Placebo comparator | Five primary health care centers of County Council of Jönköping that do not get education. Receives: Other: Control, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months in total
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start31 Oct 2018
- Primary completion5 Oct 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical Certificates for Sick Leave and Drug PrescriptionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective non-randomized trial with one interventional group and a parallel group without intervention
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- County Councils of Region Östergötland, Kalmar and Jönköping
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
- Investigators
- Fredrik H Nyström, MD, prof., Principal investigator, Region Östergötland, SwedenFredrik Nyström, MD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737019
- Sponsor's protocol ID
- 2018/323-32
- Acronym
- ACTPrimary
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34496751
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03737019
- Acronym / sponsor ID
- ACTPrimary / 2018/323-32
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- County Councils of Region Östergötland, Kalmar and Jönköping
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective non-randomized trial with one interventional group and a parallel group without intervention
| Arm | Type | Receives |
|---|---|---|
| ACT in County Council of Kalmar | Experimental | Behavioral: Education with Acceptance and Commitment TherapyGroup education with ACT in six primary health care centers in County Council of Kalmar |
| Control health care centers of County Council of Jönköping | Placebo comparator | Other: Control, no interventionFive primary health care centers of County Council of Jönköping that do not get education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- working at the health care center
Key exclusion criteria (2 listed)
- age less than 18 years
- do not work at the Health care center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education with Acceptance and Commitment TherapyGroup education with Acceptance and Commitment Therapy of the personnel at each center. | Behavioural | ACT in County Council of Kalmar |
| Control, no interventionControl, no interventions. | Other | Control health care centers of County Council of Jönköping |
Primary outcome
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.
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.
3 secondary outcomes
Assessment of how the education with ACT affect the personnel according to SF36
Time frame: 12 months
Assessment of how the education with ACT affect the personnel according to KEDS
Time frame: 12 months
Assessment of how the education with ACT affect the personnel according to WAI
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 34496751Kadowaki 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik H Nyström, MD, prof. principal investigator
Region Östergötland, Sweden
Fredrik Nyström, MD principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education with Acceptance and Commitment Therapy in people with Medical Certificates for Sick Leave and Drug Prescriptions, run by University Hospital, Linkoeping at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of medical certificates of sick leave by the doctors (time frame: 24 months in total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.