Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

Chronic Pain Clinical Trial

— PEACEFULL  

Official title:

Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561077
• Other study ID #: RC31/17/0354
• Secondary ID: 2017-A03338-45
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Mindfulness-based interventions (MBI's)
Mindfulness Based Intervention with eight sessions (one session per week) of two hours 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.

Locations

Country	Name	City	State
France	Hôpital des Enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions	The primary outcome will be the percentage of adolescents who will attend at least 6 of the 8 sessions.	End of the mindfulness program (8 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	1st session of the program (T1 week)
Secondary	Attendance rate	Percentage of adolescents present at each program session	2nd session of the program (T2 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	3rd session of the program (T3 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	4th session of the program (T4 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	5th session of the program (T5 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	6th session of the program (T6 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	7th session of the program (T7 weeks)
Secondary	Attendance rate	Percentage of adolescents present at each program session	8th session of the program (T8 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	1st session of the program (T1 week)
Secondary	Punctuality at the session	binary criterion yes/no	2nd session of the program (T2 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	3rd session of the program (T3 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	4th session of the program (T4 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	5th session of the program (T5 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	6th session of the program (T6 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	7th session of the program (T7 weeks)
Secondary	Punctuality at the session	binary criterion yes/no	8th session of the program (T8 weeks)
Secondary	Treatment acceptability	Rate of eligible adolescents who agreed to participate in the study	inclusion visit
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	2nd session of the program (T2 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	3rd session of the program (T3 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	4th session of the program (T4 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	5th session of the program (T5 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	6th session of the program (T6 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	7th session of the program (T7 weeks)
Secondary	Treatment acceptability	Daily practice at home (binary criterion yes/no)	8th session of the program (T8 weeks)
Secondary	Pain Level	Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.	Inclusion visit (baseline)
Secondary	Pain Level	Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Pain Level	Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Quality of life at baseline : impact of adolescents health on their everyday life.	Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent (VSPA) - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.	Inclusion visit (baseline)
Secondary	Quality of life at the end of program	Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Quality of life in long term	Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Chronic pain acceptance	Chronic pain acceptance will be assessed using Chronic Pain Acceptance Questionnaire, Adolescent version (CPAQ-A) translated in French. CPAQ-A has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.	Inclusion visit (baseline)
Secondary	Chronic pain acceptance	Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Chronic pain acceptance	Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Functional disability	Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.	Inclusion visit (baseline)
Secondary	Functional disability	Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Functional disability	Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Anxiety and Depression	The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.	Inclusion visit (baseline)
Secondary	Anxiety and Depression	The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Anxiety and Depression	The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Catastrophism	Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.	Inclusion visit (baseline)
Secondary	Catastrophism	Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Catastrophism	Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Mindfulness acceptance	Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.	Inclusion visit (baseline)
Secondary	Mindfulness acceptance	Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Mindfulness acceptance	Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Strengths and Difficulties	Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.	Inclusion visit (baseline)
Secondary	Strengths and Difficulties	Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Strengths and Difficulties	Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.	T3 Visit (3 months after the end of the 8-week program)
Secondary	Adolescents satisfaction	Adolescents satisfaction about the mindfulness program will be assessed using a satisfaction questionnaire with 8 items designed for this study. For each item, the modality answers are scored from 1 to 4.	T2 Visit (1 week after the end of the 8-week program)
Secondary	Parents satisfaction	Parents satisfaction about the mindfulness program followed by their children will be assessed using a satisfaction questionnaire with 8 items designed for the study.	T2 Visit (1 week after the end of the 8-week program)