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| Name | Class |
|---|---|
| University of Surrey | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT-PCCFA plus TAU | Experimental | 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. |
|
| TAU control | Other | Treatment as usual control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based cognitive therapy | Behavioral | Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
NB: for further details re the FAQL-PB and PHQ-8, please see the outcome measures section.
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| Name | Affiliation | Role |
|---|---|---|
| Ellie Craig, MSc | Canterbury Christ Church University | Principal Investigator |
| Fergal Jones, PhD, PsychD | Canterbury Christ Church University | Study Director |
| Christina Jones, PhD | University of Surrey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salomons Institute for Applied Psychology | Royal Tunbridge Wells | Kent | TN1 2YG | United Kingdom |
IPD will be available to other researchers on email request to the corresponding author after the study findings have been published in a peer reviewed journal.
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Treatment as usual | Other | Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment. |
|
| 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 separate composite scores for positive and negative emotion (i.e. 'general positive reactivity' and 'general negative reactivity'), each of which varies between 9 and 45, with higher scores indicating greater emotional reactivity. Note: this corrects a previous error where it was mistakenly stated that this scale produces a single overall score. | 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 separate composite scores for positive and negative emotion (i.e. 'general positive reactivity' and 'general negative reactivity'), each of which varies between 9 and 45, with higher scores indicating greater emotional reactivity. Note: this corrects a previous error where it was mistakenly stated that this scale produces a single overall score. | 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) |
| D004191 |
| Behavioral Disciplines and Activities |