Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies

Study Overview
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Brief Summary
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This study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).

Detailed Description
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This study is a pilot randomised controlled trial (RCT) comparing adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA) with a treatment as usual control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 15) and at follow-up (week 23).

Official Title
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Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.

Conditions
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The Quality of Life of Parents of Children With Food Allergy

Intervention / Treatment
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* Behavioral: Mindfulness-based cognitive therapy
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents or caregivers who identify as having a child under the age of 18 with a food allergy The allergy has been diagnosed by a qualified physician (e.g. GP or allergy specialist) Mean score of >=2 on the FAQL-PB, indicating they are at least 'somewhat limited/troubled' by their child's allergy (Cohen et al., 2004). Resident in the United Kingdom Have access to email, a PC/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing Exclusion Criteria: They had consulted on the design and content of the intervention or study They have already participated in a substantial mindfulness-based course They are currently engaged or are planning to engage with another psychological intervention during the course of the study They currently engage in regular mindfulness-based practice They do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice They have scores >19 on PHQ-8 (indicating 'severe' depressive symptom severity; Kroenke et al., 2009) or >15 on GAD (indicating 'severe' level of anxiety; Spitzer et al., 2006) They have a problem with alcohol or recreational drug misuse They have experienced thoughts about harming themselves or others in the last 12 months They have been given a diagnosis of psychosis They are currently experiencing high levels of distress and/or currently feeling particularly fragile They have experienced a bereavement of someone close to them in the last year or are continuing to experience continuing grief in relation to losing someone further back in time They have had traumatic experiences that they continue to be troubled by (including, but not limited to, receiving diagnosis of post-traumatic stress disorder) They experience significant difficulty being in a group with other people. NB: for further details re the FAQL-PB and PHQ-8, please see the outcome measures section.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT-PCCFA plus TAU<br>Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing, plus treatment as usual. | Behavioral: Mindfulness-based cognitive therapy<br>* Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing<br>Other: Treatment as usual<br>* Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.<br>|
| Other: TAU control<br>Treatment as usual control group | Other: Treatment as usual<br>* Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | This measures quality of life in parents of children with food allergies producing a score between 17 and 119, with higher scores indicating a greater burden on the family. | Post intervention (week 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | This measures quality of life in parents of children with food allergies producing a score between 17 and 119, with higher scores indicating a greater burden on the family. | Follow up (week 23) | 
| Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. | Follow up (week 23) | 
| Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. | Follow up (week 23) | 
| Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. | Follow up (week 23) | 
| Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. | Follow up (week 23) | 
| Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items | This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items | This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity. | Post intervention (week 23) | 
| Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. | Post intervention (week 15) | 
| Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. | Post intervention (week 23) |