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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Mindfulness-based interventions (MBI's)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness program<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance rate | Percentage of adolescents present at each program session | 1st session of the program (T1 week) | 
| Attendance rate | Percentage of adolescents present at each program session | 2nd session of the program (T2 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 3rd session of the program (T3 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 4th session of the program (T4 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 5th session of the program (T5 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 6th session of the program (T6 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 7th session of the program (T7 weeks) | 
| Attendance rate | Percentage of adolescents present at each program session | 8th session of the program (T8 weeks) | 
| Punctuality at the session | binary criterion yes/no | 1st session of the program (T1 week) | 
| Punctuality at the session | binary criterion yes/no | 2nd session of the program (T2 weeks) | 
| Punctuality at the session | binary criterion yes/no | 3rd session of the program (T3 weeks) | 
| Punctuality at the session | binary criterion yes/no | 4th session of the program (T4 weeks) | 
| Punctuality at the session | binary criterion yes/no | 5th session of the program (T5 weeks) | 
| Punctuality at the session | binary criterion yes/no | 6th session of the program (T6 weeks) | 
| Punctuality at the session | binary criterion yes/no | 7th session of the program (T7 weeks) | 
| Punctuality at the session | binary criterion yes/no | 8th session of the program (T8 weeks) | 
| Treatment acceptability | Rate of eligible adolescents who agreed to participate in the study | inclusion visit | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 2nd session of the program (T2 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 3rd session of the program (T3 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 4th session of the program (T4 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 5th session of the program (T5 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 6th session of the program (T6 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 7th session of the program (T7 weeks) | 
| Treatment acceptability | Daily practice at home (binary criterion yes/no) | 8th session of the program (T8 weeks) | 
| 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) | 
| 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) | 
| 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) | 
| 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 - 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) | 
| 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) | 
| 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) | 
| 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. | Inclusion visit (baseline) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Pediatrics, Mindfulness, Adolescents