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

• ClinicalTrials.gov Identifier: NCT04738890
• Recruitment Status: Active, not recruiting
• First Posted: February 4, 2021
• Last Update Posted: January 11, 2022
• Sponsor: Canterbury Christ Church University
• Collaborator: University of Surrey
• Information provided by (Responsible Party): Canterbury Christ Church University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
The Quality of Life of Parents of Children With Food Allergy	Behavioral: Mindfulness-based cognitive therapy; Other: Treatment as usual	Not Applicable

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
• Actual Study Start Date: March 2, 2021
• Actual Primary Completion Date: December 8, 2021
• Estimated Study Completion Date: February 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) [ Time Frame: Post intervention (week 15) ]
   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.

Secondary Outcome Measures :

1. Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) [ Time Frame: Follow up (week 23) ]
   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.
2. Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) [ Time Frame: Post intervention (week 15) ]
   This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
3. Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) [ Time Frame: Follow up (week 23) ]
   This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
4. Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8) [ Time Frame: Post intervention (week 15) ]
   This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
5. Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8) [ Time Frame: Follow up (week 23) ]
   This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
6. Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS) [ Time Frame: Post intervention (week 15) ]
   This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
7. Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS) [ Time Frame: Follow up (week 23) ]
   This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
8. Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) [ Time Frame: Post intervention (week 15) ]
   This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
9. Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) [ Time Frame: Follow up (week 23) ]
   This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
10. Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items [ Time Frame: Post intervention (week 15) ]
    This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
11. Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items [ Time Frame: Post intervention (week 23) ]
    This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
12. Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items [ Time Frame: Post intervention (week 15) ]
    This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.
13. Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items [ Time Frame: Post intervention (week 23) ]
    This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United Kingdom

Salomons Institute for Applied Psychology

Tunbridge Wells, Kent, United Kingdom, TN1 2YG

Sponsors and Collaborators

Canterbury Christ Church University

University of Surrey

Investigators

• Principal Investigator: Ellie Craig, MSc; Canterbury Christ Church University
• Study Director: Fergal Jones, PhD, PsychD; Canterbury Christ Church University
• Study Director: Christina Jones, PhD; University of Surrey

More Information

• Responsible Party: Canterbury Christ Church University
• ClinicalTrials.gov Identifier: NCT04738890
• Other Study ID Numbers: EllieCraig2021
• First Posted: February 4, 2021
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

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

Additional relevant MeSH terms:

Hypersensitivity; Food Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate