M3 Training: Motivational, Movement and Self-Management Training for Adolescents in Pain

Sponsor

Semmelweis University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05220384

Collaborator

(none)

198

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With this randomized controlled trial, we have three aims. First of all, to investigate underlying mechanisms that might contribute to the success of a physical activity focused self-management program in paediatric chronic pain.

Second of all, to determine the minimum intervention needed for improving physical activity amongst adolescents who live with chronic pain. For this we are comparing an in-person and a video-based motivational interviewing training combined with self-management techniques.

Third of all, to investigate the mediating effect of autonomy in adolescents with chronic pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: In-person Motivational Interview combined with Self-Management techniques Behavioral: Video-based Motivational Interview combined with Self-Management techniques	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Motivational, Movement and Self-Management Training for Hungarian Adolescents Living With Chronic Pain

Anticipated Study Start Date :

Jan 31, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Personalized In-person therapy	Behavioral: In-person Motivational Interview combined with Self-Management techniques This is an approximately 30 mins in-person, semi-structured, semi-personalized physical activity focused Motivational Interviewing treatment with self-management techniques. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) During the interactive treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. This in-person therapy at the hospital is followed by two booster sessions via phone at the 1st week post meeting date and 1 month post meeting date.
Other: Generalized, Video-based therapy	Behavioral: Video-based Motivational Interview combined with Self-Management techniques This is a series of three videos comprising a structured activity focused Motivational Interviewing treatment with self-management techniques. The videos' thematic follow the semi-structured interview elements to ensure that it is a true sham of the in-person one. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) This first video is going to be watched by adolescents at the hospital. During the interactive video-treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. The second video is going to be sent to the participants via e-mail on the 1st week post meeting date and the third video is on the 1-month post meeting date.

Arm

Intervention/Treatment

Other: Personalized In-person therapy

Behavioral: In-person Motivational Interview combined with Self-Management techniques

This is an approximately 30 mins in-person, semi-structured, semi-personalized physical activity focused Motivational Interviewing treatment with self-management techniques. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) During the interactive treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. This in-person therapy at the hospital is followed by two booster sessions via phone at the 1st week post meeting date and 1 month post meeting date.

Other: Generalized, Video-based therapy

Behavioral: Video-based Motivational Interview combined with Self-Management techniques

This is a series of three videos comprising a structured activity focused Motivational Interviewing treatment with self-management techniques. The videos' thematic follow the semi-structured interview elements to ensure that it is a true sham of the in-person one. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) This first video is going to be watched by adolescents at the hospital. During the interactive video-treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. The second video is going to be sent to the participants via e-mail on the 1st week post meeting date and the third video is on the 1-month post meeting date.

Outcome Measures

Primary Outcome Measures

Child Self-Efficacy Scale [3 months]
Self-Efficacy

Secondary Outcome Measures

Visual Analog Scale [3 months]
Pain Intensity
Revised Children's Anxiety and Depression Scale [3 months]
Depression, Anxiety
State-Trait Anxiety Inventory for Children [3 months]
Anxiety
Paediatric Pain Disability Index [3 months]
Disability
Pain Stages of Change Questionnaire for Adolescents and for Parents [3 months]
Readiness to change

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 12-18 years
Experiencing pain at least 3 months
Good reading, writing and listening skills in Hungarian language
Self-sufficient
Access to internet and phone
No active cancer.

Exclusion Criteria:

Age is not between 12-18 years
Experiencing pain less then 3 months
Not able to read, write and listen in Hungarian
Not self-sufficient
No access to internet and phone
Active cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University, Health Services Management Training Centre	Budapest	Pest State	Hungary	1125

Sponsors and Collaborators

Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Semmelweis University

ClinicalTrials.gov Identifier:

NCT05220384

Other Study ID Numbers:

IV/7741-3/2021/EKU

First Posted:

Feb 2, 2022

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Semmelweis University

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Feb 2, 2022