Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763889
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2021-02-02
Brief Title:
Cognitive Behaviour Therapy for Adults With Allergy
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
Feasibility Study of a Short Term Cognitive Behaviour Therapy Intervention Targeting Anxiety and Coping Styles for Adults With Allergy
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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
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 andor 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 ie 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 studys 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 anxietydistress
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
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 ie 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 studys 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 anxietydistress
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None