MotivationNCT05412537
The Impact of Motivation in Return to Work After Work Disability
A study testing MI and CAU in people with Motivation and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The current research on the impact of motivation in return to work after work disability has 2 major parts: (1) a questionnaire study for which SMEC gave approval, this part is completed, (2) a RCT. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Quality of Life, Communication
- What is being tested?
- MI and CAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Apr 2019to 27 Dec 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- speak and understand Dutch
- work disabled for longer than a month
Who cannot join
- work disabled for shorter dan 1 month or longer than 1 year
- not having the mental capabilities to understand the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
The current research on the impact of motivation in return to work after work disability has 2 major parts: (1) a questionnaire study for which SMEC gave approval, this part is completed, (2) a RCT.
The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
Read the detailed description
Work disability is a major rising problem and brings a high societal cost in European countries. The Belgian institute for public health insurance reported that costs for work disability for the first time have overgrown the costs of unemployment.
Work disability can be assessed in many ways. For a long time, a biomedical framework was used with focus on physiopathology. According to this framework, complaints and disability result from observable damage in the body (e.g., virus, fracture, lesion, etc.). Once damage is resolved, a patient is expected to resume activities and, for instance, return to work. In some cases, it is obvious that the patient is not able to work (e.g. a roofer with a broken leg) or is prohibited to resume work (e.g. a bus driver with a driving ban after an epileptic seizure). But how can the investigators explain the phenomenon that in two patients with similar pathology and complaints, the first one returns to work and the other does not? This requires a shift from a biomedical to a biopsychological perspective. The latter assumes a complex interplay between biological, psychological and even social factors on disease. A plentiful of psychological constructs have been studied in order to explain the observed heterogeneity on human suffering in the context of chronic diseases. One of these is the construct of motivation.
The research on motivation in the domain of psychology is on the rise. Binary thinking on motivation (being motivated or not) has been left behind since the introduction of intrinsic and extrinsic motivation in the 1970's by Edward Deci and Richard Ryan in their Self-Determination Theory (SDT). The SDT has been developed in the past 40 years based on scientific research and has been applied in various fields. Relatively recently this theory has been introduced to the work context and its usefulness has been proven. Research of the theory applied to the context of work disability is however still scarce.
Whereas other theories mainly look at how strongly people are motivated (a quantitative approach), the SDT emphasizes to look at the quality of this motivation. SDT suggests that higher levels of motivation do not necessarily yield more desirable outcomes if the motivation is of poor quality. The differences in the quality of motivation are associated with the regulation of the behavior being autonomous or controlled. Several studies confirm that both employees and unemployed feel better and how more desirable behaviors (e.g., search behavior, performance, helping) when having a more autonomous regulation and a less controlled regulation. For disabled, research showed that motivation can be improved through interventions helping to formulate realistic goals and empowering them to be responsible for their own participation despite their limitations. Autonomous regulation can be elicited by the individual self or by the environment by meeting the individual's basic psychological needs. SDT considers three needs as basic: the need for autonomy, need for belongingness and need for competence.
SDT is a theory that helps to understand how and why people get motivated. A framework that arose from practice and shares large similarities with SDT is Motivational Interviewing (MI). It consists of principles and techniques that are applied in order to increase client autonomy. Clients themselves generate the motivation for change, and it is a counselor's task to help clients detect ambivalence regarding behavior change, and assist them in making informed and contemplated choices to act. MI has been proven an effective approach to promote behavioral change and may therefore be especially beneficial in a RWT context as returning to work can be conceptualized as a complex human behavior change, involving physical recovery, motivation, behavior, etc. It was found that MI, in addition to routine functional restoration, is more effective than a routine functional restoration program alone in improving RTW among workers with disabling musculoskeletal disorders. Research furthermore suggested that MI may be an effective method to facilitate RTW. SDT may prove to be a useful theoretical model to understand how and why MI works within the context of RTW.
The general objective of this dissertation is to examine how motivation impacts RTW after work disability. The investigators are focusing on the question of whether motivation can be measured, and if so, whether the differences in motivation have an impact on RTW. Subsequently the question rose whether the investigators can influence motivation regarding RTW. The following research questions were investigated:
The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
- the investigators suppose that a more controlled regulation, less autonomous motivation or amotivation is associated to worse or later RTW rates or RTW behavior.
- the investigators expect a lower quality of life, lower workabilty and less satisfaction in the CAU compared to MI
- the investigators are assuming that we can influence the quality of motivation within the group of work disabled people by applying Motivational Interviewing during the consultations.
- the investigators assume better progress in motivation for people with controlled motivation compared to people with amotivation or autonomous motivation
- the investigators expect worse return to work rates after 6 months for the CAU compared to MI
- Conditions
- Motivation, Quality of Life, Communication, Health Behavior
- Being tested
- MI, CAU
- Medical subject headings
- Communication, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIOther
How to motivate people
CAUOther
consult as usual
| Study group | Role | What they receive |
|---|---|---|
| CAU | Active comparator | A sickness funds provides a physician or paramedic's consultation with people on work disability 3 to 6 months after the onset of the sickness period. The goal of this conversation is (1) to gather information on the reason of work disability, (2) gather information of the treatment plan and (3) to encourage people to RTW.
CAU stands for consult as usual Receives: Other: CAU |
| Motivational Interviewing | Experimental | Motivational Interviewing involves a conversation about behavioral change in terms of recovery or RTW. The role of the MI practitioner is to evoke change talk. By change talk, the patient expresses a desire, a reason, an ability or a need for change. It is of importance that patients themselves generate the motivation for change, and it is the practitioner's task to assist them in making informed and contemplated choices to act. The core idea is that people have to become motivated themselves to change such that the new behavior is something that they want instead of something that someone else wants. There are 4 processes: engaging, focusing, evoking and planning. Training in MI for health care professionals typically is provided in 1- to 3-day workshops. This is consistent with the 2-day training in the current research. MI was planned 3 to 6 months after the onset of work disability. Receives: Other: MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work rates
How many people have (partially) returned to work
Measured: 6 months
Secondary outcomes (6)
Quality of life SF36v2
Quality of life was measured by the EQ-5D-5L. The EQ-5D is the most well-known and commonly used generic measure of health status internationally. The 5L version appears to be a valid extension of the 3-level system. The EQ-5D-5Lt is a brief self-reported questionnaire on current health and consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of the dimensions has 3 levels of functioning: no problems, some problems, and unable to/extreme problems.Quality of life was measured at baseline and 3 months after the intervention.
Measured: 3 months
Workability index
The single-item question on work ability (Ahlstrom, Grimby-Ekman, Hagberg, \& Dellve, 2010) was used in the current research, since research shows a very strong association between the Work Ability Index (WAI; 10 items) and the single-item question. The WAI is a tool designed for occupational health services and is used today in practice as well as in research in order to assess work ability. In this study, the single-item question concerned the WAI item "current work ability compared with the lifetime best", with a possible score of 0 ("completely unable to work") to 10 ("work ability at its best"). Workability was measured at baseline, 1 week and 3 months after the intervention.
Measured: 3 months
motivation for work
The Motivation at work scale (MAWS; Gagné, Forest, Vansteenkiste, et al., 2014) is a tool to measure controlled motivation, autonomous motivation and amotivation. Participants were asked about their motivation for their latest or current job (before their work disability). Responses were made on a seven-point scale from 1 (strongly disagree) to 7 (totally agree). Controlled motivation was measured by summing up the subscales of external and introjected motivation. Autonomous motivation was measured by summing up identified and intrinsic motivation. Amotivation was rated as a separate scale. Motivation was measured at baseline and 3 months after the intervention.
Measured: 3 months
basic psychological needs
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS; Chen, Vansteenkiste, Beyers, et al., 2014) is a tool to assess basic psychological need satisfaction and basic psychological need frustration. Responses were made on a five-point scale from 1 (strongly disagree) to 5 (totally agree). Need satisfaction was measured by summing up the subscales of autonomy satisfaction, relatedness satisfaction and competence satisfaction. Need frustration was measured by summing up the subscales of autonomy frustration, relatedness frustration and competence frustration. The BPNSFS was measured at baseline, 1 week and 3 months after the intervention.
Measured: 1 week and 3 months
subjective experiences of the consult
The patients were asked to rate their conversation based on 6 questions: (1) The conversation with the doctor/paramedic has had a positive influence on the feeling to be more in control of my recovery; (2) The conversation with the doctor/paramedic has had a positive influence on the fact that I am now taking steps in my treatment; (3) The conversation with the doctor/ paramedic has had a positive effect on my family life; (4) The conversation with the physician/paramedic has had a positive influence on my self-confidence or self-image; (5) The conversation with the physician/paramedic has had a positive influence on my perspectives on work in the long term; (6) The conversation with the doctor/paramedic has had a positive influence on my perspectives on work in the short term. Responses were made on a five-point scale from 1 (strongly disagree) to 5 (totally agree). There was room for an open answer in addition to the score they gave.
Measured: 1 week and 3 months
self-efficacy
The Dutch general self-efficacy scale is a translated version of the general self-efficacy scale (Schwarzer \& Jerusalem,1995) and measures how a person thinks and handles in general based on 10 questions. The items are scored on a four-point scale, where 1 equals "completely incorrect" and 4 corresponds to "completely correct." Self-efficacy was measured at baseline, 1 week and 3 months after the intervention.
Measured: 1 week and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start23 Apr 2019
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
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 MotivationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Marc Du Bois, Prof. dr., Principal investigator, KU Leuven Environment and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412537
- Sponsor's protocol ID
- S62188
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rymenans I, Vanovenberghe C, Du Bois M, Van den Broeck A, Lauwerier E. Process Evaluation of a Motivational Interviewing Intervention in a Social Security Setting: A Qualitative Study among Work-Disabled Patients. J Occup Rehabil. 2024 Mar;34(1):141-156. doi: 10.1007/s10926-023-10108-4. Epub 2023 Apr 2.
PubMed 37009926
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Motivation in Return to Work After Work Disability
- ClinicalTrials.gov ID
- NCT05412537
- Acronym / sponsor ID
- S62188
- Conditions
- Motivation, Quality of Life, Communication, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 9 Jun 2022 (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.
The current research on the impact of motivation in return to work after work disability has 2 major parts: (1) a questionnaire study for which SMEC gave approval, this part is completed, (2) a RCT.
The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
Detailed description
Work disability is a major rising problem and brings a high societal cost in European countries. The Belgian institute for public health insurance reported that costs for work disability for the first time have overgrown the costs of unemployment.
Work disability can be assessed in many ways. For a long time, a biomedical framework was used with focus on physiopathology. According to this framework, complaints and disability result from observable damage in the body (e.g., virus, fracture, lesion, etc.). Once damage is resolved, a patient is expected to resume activities and, for instance, return to work. In some cases, it is obvious that the patient is not able to work (e.g. a roofer with a broken leg) or is prohibited to resume work (e.g. a bus driver with a driving ban after an epileptic seizure). But how can the investigators explain the phenomenon that in two patients with similar pathology and complaints, the first one returns to work and the other does not? This requires a shift from a biomedical to a biopsychological perspective. The latter assumes a complex interplay between biological, psychological and even social factors on disease. A plentiful of psychological constructs have been studied in order to explain the observed heterogeneity on human suffering in the context of chronic diseases. One of these is the construct of motivation.
The research on motivation in the domain of psychology is on the rise. Binary thinking on motivation (being motivated or not) has been left behind since the introduction of intrinsic and extrinsic motivation in the 1970's by Edward Deci and Richard Ryan in their Self-Determination Theory (SDT). The SDT has been developed in the past 40 years based on scientific research and has been applied in various fields. Relatively recently this theory has been introduced to the work context and its usefulness has been proven. Research of the theory applied to the context of work disability is however still scarce.
Whereas other theories mainly look at how strongly people are motivated (a quantitative approach), the SDT emphasizes to look at the quality of this motivation. SDT suggests that higher levels of motivation do not necessarily yield more desirable outcomes if the motivation is of poor quality. The differences in the quality of motivation are associated with the regulation of the behavior being autonomous or controlled. Several studies confirm that both employees and unemployed feel better and how more desirable behaviors (e.g., search behavior, performance, helping) when having a more autonomous regulation and a less controlled regulation. For disabled, research showed that motivation can be improved through interventions helping to formulate realistic goals and empowering them to be responsible for their own participation despite their limitations. Autonomous regulation can be elicited by the individual self or by the environment by meeting the individual's basic psychological needs. SDT considers three needs as basic: the need for autonomy, need for belongingness and need for competence.
SDT is a theory that helps to understand how and why people get motivated. A framework that arose from practice and shares large similarities with SDT is Motivational Interviewing (MI). It consists of principles and techniques that are applied in order to increase client autonomy. Clients themselves generate the motivation for change, and it is a counselor's task to help clients detect ambivalence regarding behavior change, and assist them in making informed and contemplated choices to act. MI has been proven an effective approach to promote behavioral change and may therefore be especially beneficial in a RWT context as returning to work can be conceptualized as a complex human behavior change, involving physical recovery, motivation, behavior, etc. It was found that MI, in addition to routine functional restoration, is more effective than a routine functional restoration program alone in improving RTW among workers with disabling musculoskeletal disorders. Research furthermore suggested that MI may be an effective method to facilitate RTW. SDT may prove to be a useful theoretical model to understand how and why MI works within the context of RTW.
The general objective of this dissertation is to examine how motivation impacts RTW after work disability. The investigators are focusing on the question of whether motivation can be measured, and if so, whether the differences in motivation have an impact on RTW. Subsequently the question rose whether the investigators can influence motivation regarding RTW. The following research questions were investigated:
The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
- the investigators suppose that a more controlled regulation, less autonomous motivation or amotivation is associated to worse or later RTW rates or RTW behavior.
- the investigators expect a lower quality of life, lower workabilty and less satisfaction in the CAU compared to MI
- the investigators are assuming that we can influence the quality of motivation within the group of work disabled people by applying Motivational Interviewing during the consultations.
- the investigators assume better progress in motivation for people with controlled motivation compared to people with amotivation or autonomous motivation
- the investigators expect worse return to work rates after 6 months for the CAU compared to MI
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
| Arm | Type | Receives |
|---|---|---|
| CAU | Active comparator | Other: CAUA sickness funds provides a physician or paramedic's consultation with people on work disability 3 to 6 months after the onset of the sickness period. The goal of this conversation is (1) to gather information on the reason of work disability, (2) gather information of the treatment plan and (3) to encourage people to RTW. CAU stands for consult as usual |
| Motivational Interviewing | Experimental | Other: MIMotivational Interviewing involves a conversation about behavioral change in terms of recovery or RTW. The role of the MI practitioner is to evoke change talk. By change talk, the patient expresses a desire, a reason, an ability or a need for change. It is of importance that patients themselves generate the motivation for change, and it is the practitioner's task to assist them in making informed and contemplated choices to act. The core idea is that people have to become motivated themselves to change such that the new behavior is something that they want instead of something that someone else wants. There are 4 processes: engaging, focusing, evoking and planning. Training in MI for health care professionals typically is provided in 1- to 3-day workshops. This is consistent with the 2-day training in the current research. MI was planned 3 to 6 months after the onset of work disability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- speak and understand Dutch
- work disabled for longer than a month
Key exclusion criteria (2 listed)
- work disabled for shorter dan 1 month or longer than 1 year
- not having the mental capabilities to understand the questionnaire
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 |
|---|---|---|
| MIHow to motivate people | Other | Motivational Interviewing |
| CAUconsult as usual | Other | CAU |
Primary outcome
Return to work rates
Time frame: 6 months
How many people have (partially) returned to work
6 secondary outcomes
Quality of life SF36v2
Time frame: 3 months
Workability index
Time frame: 3 months
motivation for work
Time frame: 3 months
basic psychological needs
Time frame: 1 week and 3 months
subjective experiences of the consult
Time frame: 1 week and 3 months
self-efficacy
Time frame: 1 week and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 37009926Rymenans I, Vanovenberghe C, Du Bois M, Van den Broeck A, Lauwerier E. Process Evaluation of a Motivational Interviewing Intervention in a Social Security Setting: A Qualitative Study among Work-Disabled Patients. J Occup Rehabil. 2024 Mar;34(1):141-156. doi: 10.1007/s10926-023-10108-4. Epub 2023 Apr 2.
- Individual participant dataSharing planned: No
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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.
Marc Du Bois, Prof. dr. principal investigator
KU Leuven Environment and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI and CAU in people with Motivation and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. 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?
Results are not available in the source record.
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?
Return to work rates (time frame: 6 months). 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 NCT05412537, 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 3 Jul 2024.