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

NCT ID: NCT04738890

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2022-02-02

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).

Conditions

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The Quality of Life of Parents of Children With Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based cognitive therapy

Intervention Type BEHAVIORAL

Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing

Treatment as usual

Intervention Type OTHER

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

Group Type OTHER

Treatment as usual

Intervention Type OTHER

Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.

Interventions

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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

Intervention Type BEHAVIORAL

Treatment as usual

Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Surrey

OTHER

Sponsor Role collaborator

Canterbury Christ Church University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellie Craig, MSc

Role: PRINCIPAL_INVESTIGATOR

Canterbury Christ Church University

Fergal Jones, PhD, PsychD

Role: STUDY_DIRECTOR

Canterbury Christ Church University

Christina Jones, PhD

Role: STUDY_DIRECTOR

University of Surrey

Locations

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Salomons Institute for Applied Psychology

Royal Tunbridge Wells, Kent, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EllieCraig2021

Identifier Type: -

Identifier Source: org_study_id