With-Me - Technology-Aided Phone Coaching for Occupational Health Study

Psychological Stress Clinical Trial

Official title:

With-Me - Technology-Aided Phone Coaching for Occupational Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445950
• Other study ID #: 332885 With-Me-Occ
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: April 25, 2016
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: VTT Technical Research Centre of Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Technology-aided phone wellness counselling
The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
• Phone wellness counselling
The intervention provides phone wellness counseling in occupational health.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
VTT Technical Research Centre of Finland	Firstbeat Technologies Ltd., Mawell Care Ltd, Mawell Ltd, Oulun Työterveys, Technical University of Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Primary	Psychological wellbeing	Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.	6 months	No
Secondary	Customer satisfaction for coaching	Measured by ad hoc questionnaires.	6 months	No
Secondary	Occupational health	Measured by Työoptimi occupational health questionnaire.	6 months	No
Secondary	Satisfaction to life situation	Measured by scale from 1 to 5.	6 months	No
Secondary	Self-esteem	Measured by 10-item Rosenberg's Self-Esteem Scale.	6 months	No
Secondary	Cognitive fusion	Measured by 7-item Cognitive Fusion Questionnaire	6 months	No
Secondary	Perceived stress	Measured by a single-item stress scale.	6 months	No
Secondary	Satisfaction to a relationship	The scale is modified from The Family Federation of Finland's quality test of a relationship.	6 months	No
Secondary	Activeness in conducting tasks	Self-assessment measured via phone interviews and questionnaires.	6 months	No
Secondary	Carefulness in conducting tasks	Self-assessment measured via phone interviews and questionnaires.	6 months	No
Secondary	Readiness to change	Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).	6 months	No
Secondary	Lifestyle	Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.	6 months	No
Secondary	Number of the changes made to the profile	Data from the profiling database.	1 month	No
Secondary	Perceived Accuracy of the profiling tool	Assessed by the coaches via questionnaires.	1 month	No
Secondary	Perceived ease of use	Measured by questionnaires to customers, questionnaires and interview to coaches.	6 months	No
Secondary	Perceived usefulness	Measured by the questionnaires to customers, questionnaires and interview to coaches.	6 months	No

External Links

•   Project website