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

Canterbury Christ Church University

Status: Completed

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

Treatments: Behavioral: Mindfulness-based cognitive therapy; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04738890

EllieCraig2021

Details and patient eligibility

About

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).

Full 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).

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

MBCT-PCCFA plus TAU

Experimental group

Description:

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.

Treatment:

Other: Treatment as usual

Behavioral: Mindfulness-based cognitive therapy

TAU control

Other group

Description:

Treatment as usual control group

Treatment:

Other: Treatment as usual