Psychological StressNCT02445950
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
A study testing Technology-aided phone wellness counselling and Phone wellness counselling in people with Psychological Stress, run by VTT Technical Research Centre of Finland.
Trial summary
The purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Technology-aided phone wellness counselling and Phone wellness counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jan 2016
- 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
- At least a bachelor level degree
- Age over 18 years
- Decreased psycho-physic state (own assessment)
- Is in a relationship
- Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship
- Willing to use technological wellness coaching tools, familiarity with technology
Who cannot join
- Work includes night shifts
- Acute health conditions or serious diseases
- Chronical pain affecting functionality
- Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)
- Participation in some other study
About this study
The purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.
Read the detailed description
The study focuses on mental well-being. The both interventions include intensive and independent phase.
The intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.
The independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.
- Conditions
- Psychological Stress
- Being tested
- Technology-aided phone wellness counselling, Phone wellness counselling
- Keywords
- Coaching, Well-being, Digital Health, Profiling, Customer Satisfaction, User Experience, Occupational Health, Lifestyle, Psychological Stress, Cost-Effectiveness, Guideline Adherence
- Medical subject headings
- Stress, Psychological, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-aided phone wellness counsellingBehavioural
The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
Phone wellness counsellingBehavioural
The intervention provides phone wellness counseling in occupational health.
| Study group | Role | What they receive |
|---|---|---|
| Technology-aided counseling | Experimental | Customers receive intervention via technology-aided phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. The customers are able to view their change change needs and choose tasks/goals for the coaching. The independent phase lasts 13 weeks and coaching is done via a digital tool. Receives: Behavioral: Technology-aided phone wellness counselling |
| Traditional counseling | Active comparator | Customers receive intervention via traditional phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. Change needs and goals are set during the phone calls. The independent phase lasts 13 weeks and includes 3 phone calls. Receives: Behavioral: Phone wellness counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time used for coaching
Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log. This is used to evaluate the cost of coaching.
Measured: 6 months
Psychological wellbeing
Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.
Measured: 6 months
Secondary outcomes (15)
Customer satisfaction for coaching
Measured by ad hoc questionnaires.
Measured: 6 months
Occupational health
Measured by Työoptimi occupational health questionnaire.
Measured: 6 months
Satisfaction to life situation
Measured by scale from 1 to 5.
Measured: 6 months
Self-esteem
Measured by 10-item Rosenberg's Self-Esteem Scale.
Measured: 6 months
Cognitive fusion
Measured by 7-item Cognitive Fusion Questionnaire
Measured: 6 months
Perceived stress
Measured by a single-item stress scale.
Measured: 6 months
Satisfaction to a relationship
The scale is modified from The Family Federation of Finland's quality test of a relationship.
Measured: 6 months
Activeness in conducting tasks
Self-assessment measured via phone interviews and questionnaires.
Measured: 6 months
Carefulness in conducting tasks
Self-assessment measured via phone interviews and questionnaires.
Measured: 6 months
Readiness to change
Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
Measured: 6 months
Lifestyle
Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.
Measured: 6 months
Number of the changes made to the profile
Data from the profiling database.
Measured: 1 month
Perceived Accuracy of the profiling tool
Assessed by the coaches via questionnaires.
Measured: 1 month
Perceived ease of use
Measured by questionnaires to customers, questionnaires and interview to coaches.
Measured: 6 months
Perceived usefulness
Measured by the questionnaires to customers, questionnaires and interview to coaches.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionJan 2016
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 Psychological StressStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTT Technical Research Centre of Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Firstbeat Technologies Ltd., Mawell Care Ltd, Mawell Ltd, Oulun Työterveys, Technical University of Denmark
- Responsible party
- Sponsor
- Investigators
- Hannu Nieminen, PhD, Principal investigator, Technical University of DenmarkJouni Kaartinen, DSc, Principal investigator, VTT Technical Research Centre of Finland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445950
- Sponsor's protocol ID
- 332885 With-Me-Occ
- Status last verified
- Apr 2016
- First submitted
- 6 May 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muuraiskangas ST, Honka AM, Junno UM, Nieminen HO, Kaartinen JK. A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Jul 13;24(7):e26569. doi: 10.2196/26569.
PubMed 35830233
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With-Me - Technology-Aided Phone Coaching for Occupational Health Study
- ClinicalTrials.gov ID
- NCT02445950
- Acronym / sponsor ID
- 332885 With-Me-Occ
- Conditions
- Psychological Stress
- Keywords
- Coaching, Well-being, Digital Health, Profiling, Customer Satisfaction, User Experience, Occupational Health, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VTT Technical Research Centre of FinlandUniversity, hospital or other
- Collaborators
- Firstbeat Technologies Ltd., Mawell Care Ltd, Mawell Ltd, Oulun Työterveys, Technical University of Denmark
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- 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 purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.
Detailed description
The study focuses on mental well-being. The both interventions include intensive and independent phase.
The intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.
The independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-aided counseling | Experimental | Behavioral: Technology-aided phone wellness counsellingCustomers receive intervention via technology-aided phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. The customers are able to view their change change needs and choose tasks/goals for the coaching. The independent phase lasts 13 weeks and coaching is done via a digital tool. |
| Traditional counseling | Active comparator | Behavioral: Phone wellness counsellingCustomers receive intervention via traditional phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. Change needs and goals are set during the phone calls. The independent phase lasts 13 weeks and includes 3 phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least a bachelor level degree
- Age over 18 years
- Decreased psycho-physic state (own assessment)
- Is in a relationship
- Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship
Key exclusion criteria (5 listed)
- Work includes night shifts
- Acute health conditions or serious diseases
- Chronical pain affecting functionality
- Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)
- Participation in some other study
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 |
|---|---|---|
| Technology-aided phone wellness counsellingThe intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health. | Behavioural | Technology-aided counseling |
| Phone wellness counsellingThe intervention provides phone wellness counseling in occupational health. | Behavioural | Traditional counseling |
Primary outcome
Time used for coaching
Time frame: 6 months
Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log. This is used to evaluate the cost of coaching.
Psychological wellbeing
Time frame: 6 months
Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.
15 secondary outcomes
Customer satisfaction for coaching
Time frame: 6 months
Occupational health
Time frame: 6 months
Satisfaction to life situation
Time frame: 6 months
Self-esteem
Time frame: 6 months
Cognitive fusion
Time frame: 6 months
Perceived stress
Time frame: 6 months
Satisfaction to a relationship
Time frame: 6 months
Activeness in conducting tasks
Time frame: 6 months
Carefulness in conducting tasks
Time frame: 6 months
Readiness to change
Time frame: 6 months
Lifestyle
Time frame: 6 months
Number of the changes made to the profile
Time frame: 1 month
Perceived Accuracy of the profiling tool
Time frame: 1 month
Perceived ease of use
Time frame: 6 months
Perceived usefulness
Time frame: 6 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 26 Apr 2016.
- Derived from this study: PubMed 35830233Muuraiskangas ST, Honka AM, Junno UM, Nieminen HO, Kaartinen JK. A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Jul 13;24(7):e26569. doi: 10.2196/26569.
- Project websiteLink provided by the sponsor.
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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.
Hannu Nieminen, PhD principal investigator
Technical University of Denmark
Jouni Kaartinen, DSc principal investigator
VTT Technical Research Centre of Finland Ltd
Questions about this trial
What is this clinical trial studying?
A study testing Technology-aided phone wellness counselling and Phone wellness counselling in people with Psychological Stress, run by VTT Technical Research Centre of Finland.
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 6 inclusion and 5 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time used for coaching (time frame: 6 months). 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 NCT02445950, 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 26 Apr 2016.