Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04028427
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2019-07-17
Brief Title:
Impact of ACT-based Interventions on Diabetes-related Outcomes
Sponsor:
Sophini Logeswaran
Organization:
Royal Holloway University
Study Overview
Official Title:
A Pilot Study to Examine the Effects of Mindfulness Versus Values-plus-goals Interventions for Adults With Diabetes Treated With Insulin
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Individuals with insulin-treated diabetes can experience psychological difficulties associated with living with and managing the condition Acceptance and Commitment Therapy ACT is being increasingly used to treat these psychological difficulties with research in this area indicating positive psychological and diabetes-related outcomes Gregg Callaghan Hayes Glenn-Lawson 2007 Shayeghian Hassanabadi Aguilar-Vafaie Amiri Besharat 2016 Given the lack of psychology funding in diabetes care provision a financially feasible theory-based intervention is much-needed Diabetes UK 2008 ACT may be the solution as it can be delivered in smaller modules
The study aims to investigate the effectiveness of two online ACT-based interventions a mindfulness-based intervention MBI and a values-plus-goals intervention VGI on wellbeing diabetes self-management coping style and glycaemic control among a sample of adults with insulin-treated diabetes It also aims to examine whether the interventions are associated with changes in diabetes acceptance and valued living and whether diabetes acceptance and valued living are associated with the aforementioned outcomes
Participants will be recruited from the diabetes outpatient clinics at Ashford and St Peters Hospitals NHS Foundation Trust to take part in the study They will be randomly assigned to take part in either the MBI or VGI which are both 4-week interventions Participants will be asked to complete self-report questionnaires to measure their wellbeing diabetes self-management coping style diabetes acceptance and valued living at the beginning of the study at the end of the intervention and at a 1-month follow-up Glycaemic control will be measured at the beginning of the study and at a 2-month follow up
It is hypothesised that both interventions will improve diabetes-related outcomes It is hypothesised that MBI may be associated with increases in acceptance and more positive emotion focused coping whereas the VGI may be associated with increased valued living and problem-focusedactive coping
The study aims to investigate the effectiveness of two online ACT-based interventions a mindfulness-based intervention MBI and a values-plus-goals intervention VGI on wellbeing diabetes self-management coping style and glycaemic control among a sample of adults with insulin-treated diabetes It also aims to examine whether the interventions are associated with changes in diabetes acceptance and valued living and whether diabetes acceptance and valued living are associated with the aforementioned outcomes
Participants will be recruited from the diabetes outpatient clinics at Ashford and St Peters Hospitals NHS Foundation Trust to take part in the study They will be randomly assigned to take part in either the MBI or VGI which are both 4-week interventions Participants will be asked to complete self-report questionnaires to measure their wellbeing diabetes self-management coping style diabetes acceptance and valued living at the beginning of the study at the end of the intervention and at a 1-month follow-up Glycaemic control will be measured at the beginning of the study and at a 2-month follow up
It is hypothesised that both interventions will improve diabetes-related outcomes It is hypothesised that MBI may be associated with increases in acceptance and more positive emotion focused coping whereas the VGI may be associated with increased valued living and problem-focusedactive coping
Detailed Description:
Background
Diabetes is a long-term condition which affects the way the body regulates blood sugar in around 47 million people in the United Kingdom Diabetes UK 2019 There are two types of diabetes Type 1 is when an individual is unable to produce any insulin which is a hormone that allows sugar to enter the cells in our bodies and Type 2 is when an individual no longer responds to insulin Diabetes UK 2019 Type 1 Diabetes is treated using insulin therapy and some people with Type 2 Diabetes will also need insulin therapy DeWitt Hirsch 2003
Individuals with diabetes have a greater risk of experiencing heart attacks stroke and cardiovascular diseases and complications from the condition such as amputations sight loss and kidney disease Diabetes UK 2019 They also face many psychological challenges associated with managing the condition such as depression diabetes-related distress and negative coping strategies which can lead to poorer diabetes self-management Rane Wajngot Wändell Gåfvels 2011 According to the annual diabetes prevalence figures published in 2019 by Diabetes UK around 40 of people with diabetes experience psychological difficulties and up to 65 can experience low mood related to their diabetes Those with mental health difficulties seeking physical treatment can cost the NHS up to 50 more than those without mental health difficulties Diabetes UK 2019
Psychological interventions and Acceptance and Commitment Therapy A range of psychological interventions have been used to treat individuals with diabetes such as psychoeducation about diabetes self-management problem-solving approaches and Cognitive Behavioural Therapy which aims to challenge negative thoughts Thorpe Fahey Johnson 2012 However due to the realistic nature of thoughts related to chronic health conditions at times approaches that challenge thoughts have limited effectiveness for some individuals Hofmann Sawyer Fang 2010
Acceptance and Commitment Therapy ACT Hayes Strosahl Wilson 1999 may be a promising approach for use with the diabetes population It is a therapeutic approach that is increasingly being used to treat psychological difficulties experienced by individuals with health conditions as it moves away from attempts to alter internal experiences and promotes value-based living alongside our internal experiences There is an emerging evidence base for the use of ACT with diabetes Gregg Callaghan Hayes and Glenn-Lawson 2007 demonstrated that it is effective in improving coping styles diabetes self-management and blood sugar control among adults with diabetes ACT has been shown to be effective in improving diabetes-related outcomes in other studies as well eg Shayeghian Hassanabadi Aguilar-Vafaie Amiri Besharat 2016 It has been delivered online successfully in the diabetes population through the use of smartphones suggesting that it is feasible and effective in reducing anxiety depression and diabetes-related distress eg Nes et al 2012 NHS Grampian 2015
Individuals with diabetes use a range of coping strategies to manage the condition Lazarus Folkman 1984 Karekla Karademas and Gloster 2018 proposed links between a commonly used illness self-regulation model and ACT which increases our theoretical understanding of how ACT can be helpfully applied to the difficulties experienced by people with diabetes particularly given that it can be delivered in individual modules Hayes et al 1999 ACT promotes more active coping styles through enhancing individuals values and goals and encouraging committed action Hayes et al 1999 ACTs mindfulness and acceptance components promote positive emotion-focused coping such as increased mindful awareness and learning to live alongside difficult internal experiences Therefore learning these ACT skills may result in changes in coping strategies and diabetes-related outcomes
Due to the national lack of psychology funding in diabetes services many services are not able to provide psychological interventions Diabetes UK 2008 There is a need for financially feasible and accessible interventions to support the wellbeing of patients with diabetes
Knowing which components of ACT are most effective would allow services to provide a short and more financially-feasible targeted intervention that is tailored to individuals with diabetes The study is novel as no research examining different components of ACT with people with diabetes has been published to date
Aims
The present study aims to extend previous research on using ACT within the diabetes population by taking a modular approach and examining the impact of two online ACT component-based interventions a values-plus-goals intervention VGI and a mindfulness-based intervention MBI on patients with insulin-treated diabetes In particular the investigators are interested in improving diabetes-related outcomes ie wellbeing diabetes self-management coping skills and glycaemic control by enhancing diabetes acceptance and values-based living
The research questions are
1 Do VGI and MBI significantly improve self-reported wellbeing diabetes self-management coping skills and glycaemic control in adults with insulin-treated diabetes If so are these improvements maintained at follow-up
2 Does MBI significantly increase diabetes acceptance compared to VGI
3 Does VGI significantly increase valued living compared to MBI
4 Is there an association between changes in diabetes acceptance pre-post MBI and wellbeing diabetes self-management coping skills and glycaemic control at follow-up
5 Is there an association between changes in valued living pre-post VGI and wellbeing diabetes self-management coping skills and glycaemic control at follow-up
Design
A mixed design will be employed between- and within-subjects Participants will be randomised to take part in either the mindfulness intervention or the values-plus-goals intervention They will complete self-report questionnaires on wellbeing diabetes self-management coping skills diabetes acceptance and valued living at three different time-points pre-intervention post-intervention and at a 1-month follow-up Glycaemic control will be measured pre-intervention and a 2-month follow-up
Sample setting and recruitment
The target sample will be English-speaking patients aged 18 and over who have a diagnosis of insulin-treated diabetes and are currently accessing NHS diabetes services Individuals must have an HbA1c value of 64 mmolmol or higher indicative of poor glycaemic control
The sample will be recruited from local NHS diabetes services in Ashford and St Peters Hospitals Consultant Endocrinologists from both services Dr Thang Han and Dr Helen Ward confirmed their interest in the project and granted permission for the investigators to use their services for recruitment and to collaborate on medical aspects of the project Flyers and posters will be put up in the waiting area so that interested participants can discuss the project with a member of the care team to determine eligibility and be provided with a Participant Information Sheet Clinicians and nurses will also mention the study to eligible patients at the end of their consultations where possible to raise awareness of the study and provide contact details of the researcher via the provision of a paper copy of the Participant Information Sheet and Consent Form Once eligible participants have agreed to take part they will be sent an electronic Participant Information Sheet to go through the informed consent process electronically Participants will be given ample time to consider whether they wish to take part and will have the opportunity to have any questions answered by the CI prior to the consent process
Based on an a-priori analysis on GPower using an effect size of 025 an alpha level of 005 and power of 08 Cohen 1992 a sample size of 24 per group is required for a two-tailed between- and within-factors analysis of variance In total the investigators are aiming to recruit at least 25 participants per group to ensure that they will be able to detect effects related to the hypotheses
Procedure
The study itself is web-based and will be accessible to patients from home provided that they can access the Internet All participants will receive a Qualtrics link to take part in the study They will be presented with a Participant Information Sheet to read and asked for informed consent before proceeding with the study they will also have had physical copies of these sheets They will then be randomly allocated to VGI or MBI through Qualtrics Before the intervention participants will be presented with five self-report measures to complete electronically They will then have access to the four-week intervention following which they will be asked to complete the same set of five outcome measures One month after intervention completion participants will be contacted to complete follow-up measures Glycated haemoglobin level HbA1c a widely-used indicator of glycaemic control will be recorded before the intervention and at a 2-month post-intervention follow-up as it is an average blood sugar level measure that is representative of the last 3 months
Participants will also have the opportunity to try the intervention that they were not randomly assigned to at the end of the study No further interventions would be available thereafter
Analysis
The main analyses will include
i Exploring group differences in demographic and clinical factors ii Mixed-design analyses to compare the impact of the interventions on the outcomes of interest across the three time-points analysis of variance iii Examination of changes in acceptance and valued living within each intervention group analysis of variance iv Using PROCESS analysis to explore 1 whether changes in well-being in the MBI condition is partially explained by changes in diabetes acceptance and emotion-focused coping style and 2 whether changes in self-management and glycaemic control in the VGI condition are partially explained by changes in valued living and active coping style
Data collection storage and security arrangements
Only personal information provided by participants and their clinicians to the researcher as part of the research will be accessible to the researcher ie the researcher will not have access to the participants clinical notes The researchers and co-investigators will have access to the online consent forms demographic information and self-report questionnaires as outlined in the Participant Information Sheet and agreed by participants in their consent form
All data will be anonymised therefore no one will be identifiable Each participant will be allocated a unique personal identification number which will be presented on all questionnaires demographic and clinical information sheets computerised data files and the study database A separate password-protected file containing the participants name telephone number e-mail address and study number will be kept
All data will be stored in accordance with the guidelines laid out in the NHS code of confidentiality and EU General Data Protection Regulation GDPR All data will be stored on the sponsors secure computer system Royal Holloway University of London There will be no physical data stored during the study The file containing identifiable personal information will be destroyed once the study data has been fully analysed and written up
After the study has ended research data will be stored up until the CIs fulfillment of their Doctorate in Clinical Psychology and for up to 5 years following publication in a scientific journal for audit purposes Dr Michelle Taylor will be in control of and act as the custodian for the data generated by the study
Diabetes is a long-term condition which affects the way the body regulates blood sugar in around 47 million people in the United Kingdom Diabetes UK 2019 There are two types of diabetes Type 1 is when an individual is unable to produce any insulin which is a hormone that allows sugar to enter the cells in our bodies and Type 2 is when an individual no longer responds to insulin Diabetes UK 2019 Type 1 Diabetes is treated using insulin therapy and some people with Type 2 Diabetes will also need insulin therapy DeWitt Hirsch 2003
Individuals with diabetes have a greater risk of experiencing heart attacks stroke and cardiovascular diseases and complications from the condition such as amputations sight loss and kidney disease Diabetes UK 2019 They also face many psychological challenges associated with managing the condition such as depression diabetes-related distress and negative coping strategies which can lead to poorer diabetes self-management Rane Wajngot Wändell Gåfvels 2011 According to the annual diabetes prevalence figures published in 2019 by Diabetes UK around 40 of people with diabetes experience psychological difficulties and up to 65 can experience low mood related to their diabetes Those with mental health difficulties seeking physical treatment can cost the NHS up to 50 more than those without mental health difficulties Diabetes UK 2019
Psychological interventions and Acceptance and Commitment Therapy A range of psychological interventions have been used to treat individuals with diabetes such as psychoeducation about diabetes self-management problem-solving approaches and Cognitive Behavioural Therapy which aims to challenge negative thoughts Thorpe Fahey Johnson 2012 However due to the realistic nature of thoughts related to chronic health conditions at times approaches that challenge thoughts have limited effectiveness for some individuals Hofmann Sawyer Fang 2010
Acceptance and Commitment Therapy ACT Hayes Strosahl Wilson 1999 may be a promising approach for use with the diabetes population It is a therapeutic approach that is increasingly being used to treat psychological difficulties experienced by individuals with health conditions as it moves away from attempts to alter internal experiences and promotes value-based living alongside our internal experiences There is an emerging evidence base for the use of ACT with diabetes Gregg Callaghan Hayes and Glenn-Lawson 2007 demonstrated that it is effective in improving coping styles diabetes self-management and blood sugar control among adults with diabetes ACT has been shown to be effective in improving diabetes-related outcomes in other studies as well eg Shayeghian Hassanabadi Aguilar-Vafaie Amiri Besharat 2016 It has been delivered online successfully in the diabetes population through the use of smartphones suggesting that it is feasible and effective in reducing anxiety depression and diabetes-related distress eg Nes et al 2012 NHS Grampian 2015
Individuals with diabetes use a range of coping strategies to manage the condition Lazarus Folkman 1984 Karekla Karademas and Gloster 2018 proposed links between a commonly used illness self-regulation model and ACT which increases our theoretical understanding of how ACT can be helpfully applied to the difficulties experienced by people with diabetes particularly given that it can be delivered in individual modules Hayes et al 1999 ACT promotes more active coping styles through enhancing individuals values and goals and encouraging committed action Hayes et al 1999 ACTs mindfulness and acceptance components promote positive emotion-focused coping such as increased mindful awareness and learning to live alongside difficult internal experiences Therefore learning these ACT skills may result in changes in coping strategies and diabetes-related outcomes
Due to the national lack of psychology funding in diabetes services many services are not able to provide psychological interventions Diabetes UK 2008 There is a need for financially feasible and accessible interventions to support the wellbeing of patients with diabetes
Knowing which components of ACT are most effective would allow services to provide a short and more financially-feasible targeted intervention that is tailored to individuals with diabetes The study is novel as no research examining different components of ACT with people with diabetes has been published to date
Aims
The present study aims to extend previous research on using ACT within the diabetes population by taking a modular approach and examining the impact of two online ACT component-based interventions a values-plus-goals intervention VGI and a mindfulness-based intervention MBI on patients with insulin-treated diabetes In particular the investigators are interested in improving diabetes-related outcomes ie wellbeing diabetes self-management coping skills and glycaemic control by enhancing diabetes acceptance and values-based living
The research questions are
1 Do VGI and MBI significantly improve self-reported wellbeing diabetes self-management coping skills and glycaemic control in adults with insulin-treated diabetes If so are these improvements maintained at follow-up
2 Does MBI significantly increase diabetes acceptance compared to VGI
3 Does VGI significantly increase valued living compared to MBI
4 Is there an association between changes in diabetes acceptance pre-post MBI and wellbeing diabetes self-management coping skills and glycaemic control at follow-up
5 Is there an association between changes in valued living pre-post VGI and wellbeing diabetes self-management coping skills and glycaemic control at follow-up
Design
A mixed design will be employed between- and within-subjects Participants will be randomised to take part in either the mindfulness intervention or the values-plus-goals intervention They will complete self-report questionnaires on wellbeing diabetes self-management coping skills diabetes acceptance and valued living at three different time-points pre-intervention post-intervention and at a 1-month follow-up Glycaemic control will be measured pre-intervention and a 2-month follow-up
Sample setting and recruitment
The target sample will be English-speaking patients aged 18 and over who have a diagnosis of insulin-treated diabetes and are currently accessing NHS diabetes services Individuals must have an HbA1c value of 64 mmolmol or higher indicative of poor glycaemic control
The sample will be recruited from local NHS diabetes services in Ashford and St Peters Hospitals Consultant Endocrinologists from both services Dr Thang Han and Dr Helen Ward confirmed their interest in the project and granted permission for the investigators to use their services for recruitment and to collaborate on medical aspects of the project Flyers and posters will be put up in the waiting area so that interested participants can discuss the project with a member of the care team to determine eligibility and be provided with a Participant Information Sheet Clinicians and nurses will also mention the study to eligible patients at the end of their consultations where possible to raise awareness of the study and provide contact details of the researcher via the provision of a paper copy of the Participant Information Sheet and Consent Form Once eligible participants have agreed to take part they will be sent an electronic Participant Information Sheet to go through the informed consent process electronically Participants will be given ample time to consider whether they wish to take part and will have the opportunity to have any questions answered by the CI prior to the consent process
Based on an a-priori analysis on GPower using an effect size of 025 an alpha level of 005 and power of 08 Cohen 1992 a sample size of 24 per group is required for a two-tailed between- and within-factors analysis of variance In total the investigators are aiming to recruit at least 25 participants per group to ensure that they will be able to detect effects related to the hypotheses
Procedure
The study itself is web-based and will be accessible to patients from home provided that they can access the Internet All participants will receive a Qualtrics link to take part in the study They will be presented with a Participant Information Sheet to read and asked for informed consent before proceeding with the study they will also have had physical copies of these sheets They will then be randomly allocated to VGI or MBI through Qualtrics Before the intervention participants will be presented with five self-report measures to complete electronically They will then have access to the four-week intervention following which they will be asked to complete the same set of five outcome measures One month after intervention completion participants will be contacted to complete follow-up measures Glycated haemoglobin level HbA1c a widely-used indicator of glycaemic control will be recorded before the intervention and at a 2-month post-intervention follow-up as it is an average blood sugar level measure that is representative of the last 3 months
Participants will also have the opportunity to try the intervention that they were not randomly assigned to at the end of the study No further interventions would be available thereafter
Analysis
The main analyses will include
i Exploring group differences in demographic and clinical factors ii Mixed-design analyses to compare the impact of the interventions on the outcomes of interest across the three time-points analysis of variance iii Examination of changes in acceptance and valued living within each intervention group analysis of variance iv Using PROCESS analysis to explore 1 whether changes in well-being in the MBI condition is partially explained by changes in diabetes acceptance and emotion-focused coping style and 2 whether changes in self-management and glycaemic control in the VGI condition are partially explained by changes in valued living and active coping style
Data collection storage and security arrangements
Only personal information provided by participants and their clinicians to the researcher as part of the research will be accessible to the researcher ie the researcher will not have access to the participants clinical notes The researchers and co-investigators will have access to the online consent forms demographic information and self-report questionnaires as outlined in the Participant Information Sheet and agreed by participants in their consent form
All data will be anonymised therefore no one will be identifiable Each participant will be allocated a unique personal identification number which will be presented on all questionnaires demographic and clinical information sheets computerised data files and the study database A separate password-protected file containing the participants name telephone number e-mail address and study number will be kept
All data will be stored in accordance with the guidelines laid out in the NHS code of confidentiality and EU General Data Protection Regulation GDPR All data will be stored on the sponsors secure computer system Royal Holloway University of London There will be no physical data stored during the study The file containing identifiable personal information will be destroyed once the study data has been fully analysed and written up
After the study has ended research data will be stored up until the CIs fulfillment of their Doctorate in Clinical Psychology and for up to 5 years following publication in a scientific journal for audit purposes Dr Michelle Taylor will be in control of and act as the custodian for the data generated by the study
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