Cognitive Behaviour Therapy for Adults With Allergy.

NCT04763889 | Completed DMC

• 1 other identifier: FHMS 20-21 006 EGA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

People with severe allergy often experience distress but research exploring psychological interventions for them is limited. Cognitive Behaviour Therapy (CBT) is routinely used in NHS services. The research investigators would like to know whether a short term CBT group is feasible and acceptable for those with severe allergy who are also experiencing distress and/or anxiety. The research investigators will recruit people with allergy through support groups and social media. Those interested in the study will be invited to complete a screening interview. If the participants meet the inclusion criteria and consent to take part the participants will be randomly allocated into the CBT or a self-help group. Full written consent will be needed at the telephone screening session if participants are eligible for the study. Participants will be given time to complete this prior to the intervention. Participants will be able to withdraw at any point during the study. The self-help group will be sent self-help materials. The CBT group will attend a single session day workshop based on CBT (maximum 6 hours length). Due to the Covid-19 pandemic, the workshop may need to be delivered online. If delivered online, the workshop may be delivered over two three hour sessions. Participants will be asked to complete questionnaires at baseline, the day of the intervention, one month later and three months later. They will be asked to complete a feedback form about their experiences in the group and at three month follow up, a small subsample of participants will be invited to interview. Once the data is analysed it will be written up into a report for a clinical psychology doctoral qualification major research project. It may also be published in academic journals and presented at conferences. A possible outcome of the research is that people with allergy either do or do not find the workshops an acceptable and/or feasible intervention. It will identify the potential for this intervention to reduce distress and anxiety and to improve coping skills in adults with allergy. Those who take part are welcome to contact the researchers to find out the results of the study.

Conditions

Allergy; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in the Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF, Flokstra-de Blok et al., 2009)

  Questionnaire

  Questionnaires will be given at baseline, 1 month and at 3 month follow up.

Secondary Outcomes (5)

• Change in Penn State Worry Questionnaire (PSWQ, Meyer et al., 1990)

  Questionnaires will be given at baseline, 1 month and at 3 month follow up.

• Change in Depression, Anxiety and Stress Scale-21 (DASS 21, Lovibond & Lovibond, 1995)

  Questionnaires will be given at baseline, 1 month and at 3 month follow up.

• Change in the COPE scale (Carver, Scheier & Weintraub, 1989)

  Questionnaires will be given at baseline, 1 month and at 3 month follow up.

• Change in Self-care Likert Scale (Jones et al., 2014)

  Questionnaires will be given at baseline, 1 month and at 3 month follow up.

• Change in Goal based outcome measure: clients will be asked to choose a goal at the start of the workshop and rate how well they have achieved that by the end on a 0-10 scale (0 = worst, 10 = best)

  Questionnaires will be given immediately post-intervention, after 1 month and at 3 month follow up.

Other Outcomes (3)

• Interview

  At three month follow up

• Demographic information

  Collected at baseline

• Feedback survey

  At 3 month follow up

Study Arms (2)

CBT workshop

EXPERIMENTAL

Participants will be randomly allocated to either a self-help control group or a CBT workshop group. In the intervention group participants will attend a day workshop or two half day workshops focused on using CBT to manage their anxiety and stress.

Behavioral: CBT

Self-help control treatment as usual group

NO INTERVENTION

Participants will be randomly allocated to either a self-help control group or a CBT workshop group. Participants in the treatment as usual group will receive the workshop materials after the active treatment group have completed their final follow-up at 3 months

Interventions

CBT BEHAVIORAL

CBT for those with an allergy and anxiety

CBT workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 upwards.
• Adults with an allergy diagnosed both as adults and as children.
• Adults with an allergy who report experiencing emotional distress.
• Participant is able to attend a day workshop session (6 hours maximum). This will either be delivered face to face or due to the Covid-19 pandemic these may need to be delivered online (i.e. via Zoom) rather than face to face. If this is the case the workshop may be split into two three hourly sessions. Therefore, the participant would need access to a computer, smart phone or tablet and have access to the internet.

You may not qualify if:

• Participant does not speak English.
• Participant is unable to have the capacity to provide informed consent.
• Participant is taking part in another interventional study.
• Those with severe psychological difficulties and co-morbidities, such as active psychosis, a diagnosis of a personality disorder, schizophrenia and bipolar disorder or is receiving care from mental health team.
• Those who may not be able to engage cognitively with the workshop materials and questionnaires (i.e. those with a significant learning disability).

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (9)

• Chung MC, Walsh A, Dennis I. Trauma exposure characteristics, past traumatic life events, coping strategies, posttraumatic stress disorder, and psychiatric comorbidity among people with anaphylactic shock experience. Compr Psychiatry. 2011 Jul-Aug;52(4):394-404. doi: 10.1016/j.comppsych.2010.09.005. Epub 2010 Nov 16.

  PMID: 21081226 BACKGROUND

• Knibb RC. Effectiveness of Cognitive Behaviour Therapy for Mothers of Children with Food Allergy: A Case Series. Healthcare (Basel). 2015 Nov 25;3(4):1194-211. doi: 10.3390/healthcare3041194.

  PMID: 27417820 BACKGROUND

• Knibb R, Halsey M, James P, du Toit G, Young J. Psychological services for food allergy: The unmet need for patients and families in the United Kingdom. Clin Exp Allergy. 2019 Nov;49(11):1390-1394. doi: 10.1111/cea.13488. Epub 2019 Sep 8.

  PMID: 31454459 BACKGROUND

• Cartwright-Hatton S, Ewing D, Dash S, Hughes Z, Thompson EJ, Hazell CM, Field AP, Startup H. Preventing family transmission of anxiety: Feasibility RCT of a brief intervention for parents. Br J Clin Psychol. 2018 Sep;57(3):351-366. doi: 10.1111/bjc.12177. Epub 2018 Mar 25.

  PMID: 29575043 BACKGROUND

• Flokstra-de Blok BM, van der Meulen GN, DunnGalvin A, Vlieg-Boerstra BJ, Oude Elberink JN, Duiverman EJ, Hourihane JO, Dubois AE. Development and validation of the Food Allergy Quality of Life Questionnaire - Adult Form. Allergy. 2009 Aug;64(8):1209-17. doi: 10.1111/j.1398-9995.2009.01968.x. Epub 2009 Feb 11.

  PMID: 19210345 BACKGROUND

• Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

  PMID: 2076086 BACKGROUND

• Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.

  PMID: 2926629 BACKGROUND

• Jones CJ, Smith HE, Frew AJ, Toit GD, Mukhopadhyay S, Llewellyn CD. Explaining adherence to self-care behaviours amongst adolescents with food allergy: a comparison of the health belief model and the common sense self-regulation model. Br J Health Psychol. 2014 Feb;19(1):65-82. doi: 10.1111/bjhp.12033. Epub 2013 Feb 12.

  PMID: 23398539 BACKGROUND

• Jones CJ, Tallentire H, Edgecumbe R, Sherlock G, Hale L. Online, group, low-intensity psychological intervention for adults, children, and parents with food allergy. Ann Allergy Asthma Immunol. 2024 Oct;133(4):453-461. doi: 10.1016/j.anai.2024.07.025. Epub 2024 Jul 26.

  PMID: 39069154 DERIVED

Related Links

• Lovibond, S. H., \& Lovibond, P. F. (1995). Manual for the depression anxiety stress scales (2nd ed.). Sydney: Psychology Foundation.

MeSH Terms

Conditions

Hypersensitivity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Immune System Diseases; Mental Disorders

Study Officials

• Christina Jones, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: February 2, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: July 6, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)