AllergyNCT04763889
Cognitive Behaviour Therapy for Adults With Allergy.
A study testing CBT in people with Allergy and Anxiety, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2021to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Short Term Cognitive Behaviour Therapy Intervention Targeting Anxiety and Coping Styles for Adults With Allergy.
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.
Read more
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.
Read the detailed description
Background Adults with severe allergy often experience distress but research exploring psychological interventions for this group has not been carried out. Cognitive Behaviour Therapy has previously been found to reduce distress in mothers of children with severe allergy. Indeed, there are two allergy specialist clinics in the UK which offer interventions to children and families with severe allergy. Initial investigations have shown these clinics to be beneficial. It is clear that a study is needed to explore the feasibility of a CBT intervention for adults with severe allergy in order for further research to be conducted and to improve outcomes for this group.
The feasibility study will involve recruiting adults with severe allergy and inviting them to screening interview phone call. If suitable for the study, participants will be randomly allocated to an intervention or control group. Those in the intervention group will be invited to attend a single session 6 hour workshop focusing on adapted CBT for allergy. There is evidence that single session workshops can be beneficial in managing anxiety. The workshop in the current study will either be face to face groups or due to the Covid-19 pandemic, the workshops may be delivered on online platforms, such as Zoom. If delivered online, the workshop will likely to be split over two three hour sessions. Online delivery of the intervention may be more beneficial for those with disabilities, who may be at a higher risk of experiencing complications due to the Coronavirus i.e. those with allergy and asthma. Indeed, delivery online would lead to flexibility for participants who may be located across the UK without needing to travel long distances. Those who have long term health problems may prefer the flexibility of online delivery as this limits their need to travel. This may also suit parents who would not necessarily need childcare arrangements for an online workshop.
Those in the control group will be sent self-help information. Questionnaire measures will explore quality of life, coping style, anxiety, worry, stress and depression. Questionnaires will also explore personal goals for therapy and self-care behaviours. With questionnaire measures, reliable change and the proportion meeting 'clinical caseness' pre and post intervention will be explored to provide a signal of efficacy of the intervention. Changes between the groups will also be assessed. As the study is assessing feasibility, retention and uptake will be assessed. Feedback questionnaires at the end of the study, including free text responses and Likert Scale questionnaires, will also be collected to assess acceptability and to explore participant experiences of the study. Additionally, qualitative interviews with a small subsample of participants being followed up after three months will also be conducted to assess acceptability. The interviews will focus on participants experiences of living with an allergy and the experience of the workshop and research.
Aims of the study
The study's objective is to assess the feasibility and acceptability of a short term CBT group intervention for reducing anxiety and distress in those with severe allergy. The research questions are:
- Can appropriate participants be recruited and retained to the group intervention?
- How appropriate are the data collection procedures and outcome measures for the participants and purposes of the study?
- Are study procedures and workshop intervention suitable for and acceptable to participants?
- What is it like to attend a group intervention for people with severe allergy and anxiety/distress?
- Does the intervention provide a signal of efficacy to warrant a definitive trial?
Method Participants with allergy will be recruited through support groups and social media. Those who are interested in the study will be asked to complete a screening interview. If they meet inclusion criteria and consent to take part they will be randomly allocated into either an intervention or a control group. The intervention group will attend a single session day workshop based on CBT. The control group will be sent self-help materials. Due to the Covid-19 pandemic, the workshop may need to be delivered online. If delivered online, the workshop may be delivered over two sessions. Participants will be asked to complete feedback forms about their experiences in the group. At three month follow up, a small subsample of participants will be interviewed. The interviews will focus on participants experiences of living with an allergy and the experience of the workshop and research.
Results A possible outcome is that people with allergy and emotional distress either do or do not find the workshops an acceptable and feasible intervention. It will identify dropout rates and participant retention. It will also identify the potential for this intervention to reduce distress and anxiety and to improve coping skills in adults with severe allergy.
Implications If the outcome of the study is that CBT is an acceptable intervention for those with severe allergy and emotional distress, it adds weight to the argument that more research is needed to explore this on a larger scale. If the outcome measures are acceptable for this client group, they could be used in a future definitive trial.
- Being tested
- CBT
- Medical subject headings
- Hypersensitivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
CBT for those with an allergy and anxiety
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF, Flokstra-de Blok et al., 2009)
Questionnaire
Measured: 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)
Questionnaire
Measured: 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)
Questionnaire. 21 items. Rate on a scale from 0-3 how much each statement applied to them. Three factors: depression, anxiety and stress. The higher the score the higher the levels of depression, anxiety and stress.
Measured: Questionnaires will be given at baseline, 1 month and at 3 month follow up.
Change in the COPE scale (Carver, Scheier & Weintraub, 1989)
Questionnaire. 60 items. Participants rate on a 4 point Likert Scale (1-4). This measures 15 coping strategies and 4 factors including problem focused, emotion focused, avoidance focused and acceptance focused coping. There is no 'overall score' for this measure but higher scores on specific coping styles suggesting more use of this.
Measured: Questionnaires will be given at baseline, 1 month and at 3 month follow up.
Change in Self-care Likert Scale (Jones et al., 2014)
Questionnaire. Five items. Responses are measured on a 6-point scale (0-5) how much each statement applies to them. Higher the score suggests poorer self-care behaviours.
Measured: 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)
Questionnaire
Measured: Questionnaires will be given immediately post-intervention, after 1 month and at 3 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start2 Feb 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Jones, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763889
- Sponsor's protocol ID
- FHMS 20-21 006 EGA
- Status last verified
- Aug 2021
- First submitted
- 2 Feb 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21081226Knibb 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.
PubMed 27417820Knibb 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.
PubMed 31454459Cartwright-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.
PubMed 29575043Flokstra-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.
PubMed 19210345Meyer 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.
PubMed 2076086Carver 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.
PubMed 2926629Jones 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.
PubMed 23398539Jones 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.
PubMed 39069154
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Short Term Cognitive Behaviour Therapy Intervention Targeting Anxiety and Coping Styles for Adults With Allergy.
- ClinicalTrials.gov ID
- NCT04763889
- Acronym / sponsor ID
- FHMS 20-21 006 EGA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Adults with severe allergy often experience distress but research exploring psychological interventions for this group has not been carried out. Cognitive Behaviour Therapy has previously been found to reduce distress in mothers of children with severe allergy. Indeed, there are two allergy specialist clinics in the UK which offer interventions to children and families with severe allergy. Initial investigations have shown these clinics to be beneficial. It is clear that a study is needed to explore the feasibility of a CBT intervention for adults with severe allergy in order for further research to be conducted and to improve outcomes for this group.
The feasibility study will involve recruiting adults with severe allergy and inviting them to screening interview phone call. If suitable for the study, participants will be randomly allocated to an intervention or control group. Those in the intervention group will be invited to attend a single session 6 hour workshop focusing on adapted CBT for allergy. There is evidence that single session workshops can be beneficial in managing anxiety. The workshop in the current study will either be face to face groups or due to the Covid-19 pandemic, the workshops may be delivered on online platforms, such as Zoom. If delivered online, the workshop will likely to be split over two three hour sessions. Online delivery of the intervention may be more beneficial for those with disabilities, who may be at a higher risk of experiencing complications due to the Coronavirus i.e. those with allergy and asthma. Indeed, delivery online would lead to flexibility for participants who may be located across the UK without needing to travel long distances. Those who have long term health problems may prefer the flexibility of online delivery as this limits their need to travel. This may also suit parents who would not necessarily need childcare arrangements for an online workshop.
Those in the control group will be sent self-help information. Questionnaire measures will explore quality of life, coping style, anxiety, worry, stress and depression. Questionnaires will also explore personal goals for therapy and self-care behaviours. With questionnaire measures, reliable change and the proportion meeting 'clinical caseness' pre and post intervention will be explored to provide a signal of efficacy of the intervention. Changes between the groups will also be assessed. As the study is assessing feasibility, retention and uptake will be assessed. Feedback questionnaires at the end of the study, including free text responses and Likert Scale questionnaires, will also be collected to assess acceptability and to explore participant experiences of the study. Additionally, qualitative interviews with a small subsample of participants being followed up after three months will also be conducted to assess acceptability. The interviews will focus on participants experiences of living with an allergy and the experience of the workshop and research.
Aims of the study
The study's objective is to assess the feasibility and acceptability of a short term CBT group intervention for reducing anxiety and distress in those with severe allergy. The research questions are:
- Can appropriate participants be recruited and retained to the group intervention?
- How appropriate are the data collection procedures and outcome measures for the participants and purposes of the study?
- Are study procedures and workshop intervention suitable for and acceptable to participants?
- What is it like to attend a group intervention for people with severe allergy and anxiety/distress?
- Does the intervention provide a signal of efficacy to warrant a definitive trial?
Method Participants with allergy will be recruited through support groups and social media. Those who are interested in the study will be asked to complete a screening interview. If they meet inclusion criteria and consent to take part they will be randomly allocated into either an intervention or a control group. The intervention group will attend a single session day workshop based on CBT. The control group will be sent self-help materials. Due to the Covid-19 pandemic, the workshop may need to be delivered online. If delivered online, the workshop may be delivered over two sessions. Participants will be asked to complete feedback forms about their experiences in the group. At three month follow up, a small subsample of participants will be interviewed. The interviews will focus on participants experiences of living with an allergy and the experience of the workshop and research.
Results A possible outcome is that people with allergy and emotional distress either do or do not find the workshops an acceptable and feasible intervention. It will identify dropout rates and participant retention. It will also identify the potential for this intervention to reduce distress and anxiety and to improve coping skills in adults with severe allergy.
Implications If the outcome of the study is that CBT is an acceptable intervention for those with severe allergy and emotional distress, it adds weight to the argument that more research is needed to explore this on a larger scale. If the outcome measures are acceptable for this client group, they could be used in a future definitive trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT workshop | Experimental | Behavioral: CBTParticipants 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTCBT for those with an allergy and anxiety | Behavioural | CBT workshop |
Primary outcome
Change in the Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF, Flokstra-de Blok et al., 2009)
Time frame: Questionnaires will be given at baseline, 1 month and at 3 month follow up.
Questionnaire
5 secondary outcomes
Change in Penn State Worry Questionnaire (PSWQ, Meyer et al., 1990)
Time frame: 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)
Time frame: Questionnaires will be given at baseline, 1 month and at 3 month follow up.
Change in the COPE scale (Carver, Scheier & Weintraub, 1989)
Time frame: Questionnaires will be given at baseline, 1 month and at 3 month follow up.
Change in Self-care Likert Scale (Jones et al., 2014)
Time frame: 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)
Time frame: Questionnaires will be given immediately post-intervention, after 1 month and at 3 month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 21081226Chung 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.
- Background: PubMed 27417820Knibb 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.
- Background: PubMed 31454459Knibb 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.
- Background: PubMed 29575043Cartwright-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.
- Background: PubMed 19210345Flokstra-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.
- Background: PubMed 2076086Meyer 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.
- Background: PubMed 2926629Carver 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.
- Background: PubMed 23398539Jones 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.
- Derived from this study: PubMed 39069154Jones 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.
- Lovibond, S. H., \& Lovibond, P. F. (1995). Manual for the depression anxiety stress scales (2nd ed.). Sydney: Psychology Foundation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Jones, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Allergy and Anxiety, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF, Flokstra-de Blok et al., 2009) (time frame: Questionnaires will be given at baseline, 1 month and at 3 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763889, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.