Clinical trial NCT04738890: Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies
Official title: Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Quality of Life of Parents of Children With Food Allergy
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: University of Surrey
First posted: 2021-02-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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.

Primary outcomes:
measure: Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
timeFrame: Post intervention (week 15)
Secondary outcomes:
measure: Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
timeFrame: Follow up (week 23)
measure: Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
timeFrame: Follow up (week 23)
measure: Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8)
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8)
timeFrame: Follow up (week 23)
measure: Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS)
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS)
timeFrame: Follow up (week 23)
measure: Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
timeFrame: Follow up (week 23)
measure: Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items
timeFrame: Post intervention (week 23)
measure: Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items
timeFrame: Post intervention (week 15)
measure: Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items
timeFrame: Post intervention (week 23)
Other outcomes:
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Salomons Institute for Applied Psychology
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Ellie Craig, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canterbury Christ Church University
name: Fergal Jones, PhD, PsychD
role: STUDY_DIRECTOR
affiliation: University of Surrey
name: Christina Jones, PhD
role: STUDY_DIRECTOR
References: