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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04738890
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Canterbury Christ Church University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ellie Craig, MScFergal Jones, PhD, PsychDChristina Jones, PhD
Principal Investigator Affiliation Canterbury Christ Church UniversityCanterbury Christ Church UniversityUniversity of Surrey
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

The Quality of Life of Parents of Children With Food Allergy
Additional Details

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).

Arms & Interventions

Arms

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.

Other: TAU control

Treatment as usual control group

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tunbridge Wells, Kent, United Kingdom

Status

Recruiting

Address

Salomons Institute for Applied Psychology

Tunbridge Wells, Kent, TN1 2YG

Site Contact

Ellie Craig, MSc

e.craig606@canterbury.ac.uk

01227 927110

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