Clinical trial NCT03561077: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain
Official title: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Pain
Pediatrics
Mindfulness
Adolescents
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

Detailed description: Paediatric chronic pain can lead to serious consequences in terms of daily functioning (school absenteeism and loss of social interactions) and global quality of life. Mindfulness-based interventions (MBI's) approaches which emphasize acceptance rather than control of pain have gained increasing attention in adults with chronic pain. The effectiveness of MBI's for chronic pain in paediatric population remains largely unknown. An MBI program for adolescent was conducted in Toronto's Hospital for Sick Children and happened to be feasible and well received for adolescents with chronic pain conditions. The aim of the present program is to study the feasibility in France of a mindfulness program dedicated for adolescents with chronic pain.

An eight-session, two hour Mindfulness Based Intervention dedicated to adolescents will be provided. The intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. Topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.

Eligibility criteria: Inclusion Criteria:

* Teenagers from 12 to 17 years of age followed at the Children's Hospital of Toulouse, as part of the Multidisciplinary Consultation of Pain
* including French.
* With the consent of the teenager and the parents
* Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

* intellectual deficit not allowing to participate in a meditation program
* participating in research involving body therapies

Primary outcomes:
measure: Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions
timeFrame: End of the mindfulness program (8 weeks)
Secondary outcomes:
measure: Attendance rate
timeFrame: 1st session of the program (T1 week)
measure: Attendance rate
timeFrame: 2nd session of the program (T2 weeks)
measure: Attendance rate
timeFrame: 3rd session of the program (T3 weeks)
measure: Attendance rate
timeFrame: 4th session of the program (T4 weeks)
measure: Attendance rate
timeFrame: 5th session of the program (T5 weeks)
measure: Attendance rate
timeFrame: 6th session of the program (T6 weeks)
measure: Attendance rate
timeFrame: 7th session of the program (T7 weeks)
measure: Attendance rate
timeFrame: 8th session of the program (T8 weeks)
measure: Punctuality at the session
timeFrame: 1st session of the program (T1 week)
measure: Punctuality at the session
timeFrame: 2nd session of the program (T2 weeks)
measure: Punctuality at the session
timeFrame: 3rd session of the program (T3 weeks)
measure: Punctuality at the session
timeFrame: 4th session of the program (T4 weeks)
measure: Punctuality at the session
timeFrame: 5th session of the program (T5 weeks)
measure: Punctuality at the session
timeFrame: 6th session of the program (T6 weeks)
measure: Punctuality at the session
timeFrame: 7th session of the program (T7 weeks)
measure: Punctuality at the session
timeFrame: 8th session of the program (T8 weeks)
measure: Treatment acceptability
timeFrame: inclusion visit
measure: Treatment acceptability
timeFrame: 2nd session of the program (T2 weeks)
measure: Treatment acceptability
timeFrame: 3rd session of the program (T3 weeks)
measure: Treatment acceptability
timeFrame: 4th session of the program (T4 weeks)
measure: Treatment acceptability
timeFrame: 5th session of the program (T5 weeks)
measure: Treatment acceptability
timeFrame: 6th session of the program (T6 weeks)
measure: Treatment acceptability
timeFrame: 7th session of the program (T7 weeks)
measure: Treatment acceptability
timeFrame: 8th session of the program (T8 weeks)
measure: Pain Level
timeFrame: Inclusion visit (baseline)
measure: Pain Level
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Pain Level
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Quality of life at baseline : impact of adolescents health on their everyday life.
timeFrame: Inclusion visit (baseline)
measure: Quality of life at the end of program
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Quality of life in long term
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Chronic pain acceptance
timeFrame: Inclusion visit (baseline)
measure: Chronic pain acceptance
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Chronic pain acceptance
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Functional disability
timeFrame: Inclusion visit (baseline)
measure: Functional disability
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Functional disability
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Anxiety and Depression
timeFrame: Inclusion visit (baseline)
measure: Anxiety and Depression
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Anxiety and Depression
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Catastrophism
timeFrame: Inclusion visit (baseline)
measure: Catastrophism
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Catastrophism
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Mindfulness acceptance
timeFrame: Inclusion visit (baseline)
measure: Mindfulness acceptance
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Mindfulness acceptance
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Strengths and Difficulties
timeFrame: Inclusion visit (baseline)
measure: Strengths and Difficulties
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Strengths and Difficulties
timeFrame: T3 Visit (3 months after the end of the 8-week program)
measure: Adolescents satisfaction
timeFrame: T2 Visit (1 week after the end of the 8-week program)
measure: Parents satisfaction
timeFrame: T2 Visit (1 week after the end of the 8-week program)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital des Enfants
Study officials:
affiliation: University Hospital, Toulouse
name: Agnès SUC, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297.
citation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
citation: Zenner C, Herrnleben-Kurz S, Walach H. Mindfulness-based interventions in schools-a systematic review and meta-analysis. Front Psychol. 2014 Jun 30;5:603. doi: 10.3389/fpsyg.2014.00603. eCollection 2014.
citation: Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22.
citation: Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1.
citation: Ruskin D, Harris L, Stinson J, Kohut SA, Walker K, McCarthy E. "I Learned to Let Go of My Pain". The Effects of Mindfulness Meditation on Adolescents with Chronic Pain: An Analysis of Participants' Treatment Experience. Children (Basel). 2017 Dec 15;4(12):110. doi: 10.3390/children4120110.
citation: Ruskin DA, Gagnon MM, Kohut SA, Stinson JN, Walker KS. A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Clin J Pain. 2017 Nov;33(11):1019-1029. doi: 10.1097/AJP.0000000000000490.