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

• ClinicalTrials.gov Identifier: NCT03561077
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: August 25, 2020
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Study Description

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

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Other: Mindfulness-based interventions (MBI's)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain
• Actual Study Start Date: May 2, 2018
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Mindfulness program; To study the feasibility in France of a mindfulness program with mindfulness-based interventions (MBI's) dedicated for adolescents with chronic pain.

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions [ Time Frame: End of the mindfulness program (8 weeks) ]
   The primary outcome will be the percentage of adolescents who will attend at least 6 of the 8 sessions.

Secondary Outcome Measures :

1. Attendance rate [ Time Frame: 1st session of the program (T1 week) ]
   Percentage of adolescents present at each program session
2. Attendance rate [ Time Frame: 2nd session of the program (T2 weeks) ]
   Percentage of adolescents present at each program session
3. Attendance rate [ Time Frame: 3rd session of the program (T3 weeks) ]
   Percentage of adolescents present at each program session
4. Attendance rate [ Time Frame: 4th session of the program (T4 weeks) ]
   Percentage of adolescents present at each program session
5. Attendance rate [ Time Frame: 5th session of the program (T5 weeks) ]
   Percentage of adolescents present at each program session
6. Attendance rate [ Time Frame: 6th session of the program (T6 weeks) ]
   Percentage of adolescents present at each program session
7. Attendance rate [ Time Frame: 7th session of the program (T7 weeks) ]
   Percentage of adolescents present at each program session
8. Attendance rate [ Time Frame: 8th session of the program (T8 weeks) ]
   Percentage of adolescents present at each program session
9. Punctuality at the session [ Time Frame: 1st session of the program (T1 week) ]
   binary criterion yes/no
10. Punctuality at the session [ Time Frame: 2nd session of the program (T2 weeks) ]
    binary criterion yes/no
11. Punctuality at the session [ Time Frame: 3rd session of the program (T3 weeks) ]
    binary criterion yes/no
12. Punctuality at the session [ Time Frame: 4th session of the program (T4 weeks) ]
    binary criterion yes/no
13. Punctuality at the session [ Time Frame: 5th session of the program (T5 weeks) ]
    binary criterion yes/no
14. Punctuality at the session [ Time Frame: 6th session of the program (T6 weeks) ]
    binary criterion yes/no
15. Punctuality at the session [ Time Frame: 7th session of the program (T7 weeks) ]
    binary criterion yes/no
16. Punctuality at the session [ Time Frame: 8th session of the program (T8 weeks) ]
    binary criterion yes/no
17. Treatment acceptability [ Time Frame: inclusion visit ]
    Rate of eligible adolescents who agreed to participate in the study
18. Treatment acceptability [ Time Frame: 2nd session of the program (T2 weeks) ]
    Daily practice at home (binary criterion yes/no)
19. Treatment acceptability [ Time Frame: 3rd session of the program (T3 weeks) ]
    Daily practice at home (binary criterion yes/no)
20. Treatment acceptability [ Time Frame: 4th session of the program (T4 weeks) ]
    Daily practice at home (binary criterion yes/no)
21. Treatment acceptability [ Time Frame: 5th session of the program (T5 weeks) ]
    Daily practice at home (binary criterion yes/no)
22. Treatment acceptability [ Time Frame: 6th session of the program (T6 weeks) ]
    Daily practice at home (binary criterion yes/no)
23. Treatment acceptability [ Time Frame: 7th session of the program (T7 weeks) ]
    Daily practice at home (binary criterion yes/no)
24. Treatment acceptability [ Time Frame: 8th session of the program (T8 weeks) ]
    Daily practice at home (binary criterion yes/no)
25. Pain Level [ Time Frame: Inclusion visit (baseline) ]
    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.
26. Pain Level [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
27. Pain Level [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
28. Quality of life at baseline : impact of adolescents health on their everyday life. [ Time Frame: Inclusion visit (baseline) ]
    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.
29. Quality of life at the end of program [ Time Frame: T2 Visit (1 week after the end of the 8-week 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.
30. Quality of life in long term [ Time Frame: T3 Visit (3 months after the end of the 8-week 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.
31. Chronic pain acceptance [ Time Frame: Inclusion visit (baseline) ]
    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.
32. Chronic pain acceptance [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
33. Chronic pain acceptance [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
34. Functional disability [ Time Frame: Inclusion visit (baseline) ]
    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.
35. Functional disability [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
36. Functional disability [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
37. Anxiety and Depression [ Time Frame: Inclusion visit (baseline) ]
    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.
38. Anxiety and Depression [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
39. Anxiety and Depression [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
40. Catastrophism [ Time Frame: Inclusion visit (baseline) ]
    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.
41. Catastrophism [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
42. Catastrophism [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
43. Mindfulness acceptance [ Time Frame: Inclusion visit (baseline) ]
    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.
44. Mindfulness acceptance [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
45. Mindfulness acceptance [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
46. Strengths and Difficulties [ Time Frame: Inclusion visit (baseline) ]
    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.
47. Strengths and Difficulties [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
48. Strengths and Difficulties [ Time Frame: T3 Visit (3 months after the end of the 8-week program) ]
    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.
49. Adolescents satisfaction [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    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.
50. Parents satisfaction [ Time Frame: T2 Visit (1 week after the end of the 8-week program) ]
    Parents satisfaction about the mindfulness program followed by their children will be assessed using a satisfaction questionnaire with 8 items designed for the study.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Agnès SUC, MD; 5 34 55 86 61 ext 33; suc.a@chu-toulouse.fr

Contact: Stéphanie IANUZZI, PhD; IANNUZZI.S@chu-toulouse.fr

Locations

France

Hôpital des Enfants; Recruiting

Toulouse, France, 31059

Contact: Agnès SUC, MD

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

• Principal Investigator: Agnès SUC, MD; University Hospital, Toulouse

More Information

Publications:

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. Review.

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.

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.

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.

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.

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). pii: E110. doi: 10.3390/children4120110.

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.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT03561077
• Other Study ID Numbers: RC31/17/0354; 2017-A03338-45 ( Other Identifier: ID-RCB )
• First Posted: June 19, 2018
• Last Update Posted: August 25, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:

Pain; Pediatrics; Mindfulness; Adolescents

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations