Internet Intervention for Diabetes Distress
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|ClinicalTrials.gov Identifier: NCT03077997|
Recruitment Status : Terminated (logistics recruitment)
First Posted : March 13, 2017
Last Update Posted : September 11, 2018
|First Submitted Date ICMJE||February 20, 2017|
|First Posted Date ICMJE||March 13, 2017|
|Last Update Posted Date||September 11, 2018|
|Actual Study Start Date ICMJE||March 15, 2017|
|Actual Primary Completion Date||July 15, 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Diabetes Distress (As measured by the Diabetes Distress Scale) [ Time Frame: At the end of treatment (week 8) ]
Diabetes Distress Scale (DDS; Polonsky et al., 2005; Fisher et al., 2008) is a 17-item measure that focuses on 4 aspects of distress associated with diabetes: emotional burden, regimen distress, interpersonal distress and physician distress. The measure and its 4 subscales have demonstrated good internal consistency (α > .87) and convergent validity with the Center for Epidemiological Studies Depression Scale, meal planning, exercise and total cholesterol (Polonsky et al., 2005).
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03077997 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Internet Intervention for Diabetes Distress|
|Official Title ICMJE||Acceptability and Clinical Feasibility of an Internet-delivered Intervention for Psychological Distress in Patients With Type 2 Diabetes|
|Brief Summary||Diabetes distress is a psychological phenomenon associated with the self-management of the disease and is characterised by feelings of anxiety, guilt, helplessness, defeat, and depression. Research suggests that internet-delivered interventions have the potential to increase people's ability to self-manage their symptoms, but whether they are effective is largely unknown. This study is designed to investigate the potential effectiveness of an internet-delivered intervention for diabetes distress in patients with type 2 diabetes.|
Diabetes is a chronic metabolic endocrine disorder characterised by the inability to metabolise glucose effectively. It is associated with reduced life expectancy, significant morbidity due to specific diabetes related complications, and increased risk of complications such as heart disease, stroke, and diminished quality of life. The incidence of diabetes is on the increase with approximately 347 million adults affected worldwide. Type 2 diabetes accounts for 90-95% of these cases and figures are estimated to increase to 552 million by 2030.
Lifestyle changes such as a reduction in exercise and an increase in dietary intake over the past number of years have been flagged as being responsible for this dramatic surge in the prevalence of Type 2 diabetes on a global scale.
Because diabetes is a chronic and progressive condition people not only require regular access to medical care, but the ability to self-manage symptoms on a daily basis is now considered to be an essential part of treatment. Self-management involves the continuous monitoring of dietary intake, physical activity, general health, stress levels, blood sugar levels, and adherence to medication regimens. Diabetes is a demanding illness that requires complex self-management maintenance/care on a daily basis. Coping with these demands and maintaining lifestyle changes can often be overwhelming for individuals and this can result in significant distress that includes feelings of anxiety, guilt, helplessness, defeat, and depression.
Research has demonstrated that those who display high levels of such symptoms are not necessarily clinically depressed; rather they experience high levels of emotional distress related to diabetes and their management of the disease. Diabetes distress is a distinct condition that directly relates to diabetes outcomes. It is characterised by unique emotional issues that directly relate to the burden of living with diabetes such as worry, frustration, concern and aspects of burnout.
Several factors prevent people with diabetes from accessing support and treatment for any distress they may experience in self-managing, such as poor education, personal finances, physical access to services, lack of social support, poor motivation, low self-efficacy, and negative attitudes to treatments. In addition the concept of diabetic distress is relatively new and unknown. This highlights the growing need to develop effective treatment options to overcome barriers to access for people with type 2 diabetes.
A significant amount of research in recent years has focused on diabetes self-management education and its effectiveness for improving diabetes care and glycemic control. Face-to-face lifestyle interventions with a particular focus on behaviour change are not new in the treatment and management of type 2 diabetes. In recent years, computer-based interventions have been shown to be effective for behaviour change (e.g. in smoking cessation). Researchers are now investigating whether there is a practical and cost-effective use for computer-based interventions to address more complex behaviour change such as that required in chronic disease self-management such as Type 2 diabetes .
Previous reviews of internet-delivered interventions for people with diabetes demonstrated some effects on physical and lifestyle self-management but failed to have any great impact on psychological outcomes. Previous work seems to demonstrate the need for further more integrated approaches that considers both health behaviours and their modification and behavioural health, specifically addressing significant distress that includes feelings of anxiety, guilt, helplessness, defeat, and depression. However, can an internet-delivered intervention address the self-management of diabetes through a comprehensive consideration of the distress that so often underlies the dysregulation of self-management regimes and the inevitable consequences of that? The current study seeks to begin an attempted answer by considering the clinical feasibility of a newly developed intervention called Space from Diabetes.
A mixed-method approach will be used that captures both quantitative and qualitative data. After completing screening questionnaires, eligible patients will be invited to use the intervention over an 8 week period.
The investigators intend to recruit participants from Enfield Community Service. A sample size of 35 participants is proposed. This sample size will allow us to estimate the standard deviation of the symptom outcome measures for a future RCT.
Eligible patients will be invited to use the intervention over an 8 week period. The program will be advertised to patients through Enfield Community Service and GP surgeries via leaflets distributed by staff members. Participant information sheets will be administered before beginning the programme and consent forms will be obtained at the point of sign-up online. Participants can sign up online using the link provided on the leaflet to get access to the program. Participants will sign the consent form and complete screening measures online before beginning the program. Participants will then be referred to a supporter from within Enfield Community Service. Participants' post outcome measures will be gathered 8 weeks after their initial login or activation of the programme.
Information made available to all prospective participants will inform them of exactly what is involved in participating, including the objectives of the trial and its importance. Informed consent will be obtained from each participant before they begin to use the programme. Participants will know that their involvement is voluntary and they can withdraw their participation at any time without prejudice. In order to record participant data gathered during the survey questionnaire and focus groups, participants will be fully informed about all the material that is recorded. Moreover, data will be anonymised and stored in a secure and encrypted server and retained for seven years as original source. Postal information will be collected for the purpose of participant remuneration only. This data will be kept on a separate secure and encrypted server with unique identifiers.
All materials will be submitted to appropriate ethics committee for review and approval.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Space from Diabetes
Space from Diabetes is an internet-delivered cognitive behaviour therapy-based programme for symptoms of depression, anxiety, & diabetes distress in people with type 2 diabetes mellitus.
|Study Arms ICMJE||Experimental: Space from Diabetes
Participants will be assigned the 'Space from Diabetes' intervention in a supported mode for 8 weeks. Participants are assigned a clinical supporter, who will be a psychological well-being practitioner in an NHS Mental Health Service. As the participant works through the programme content, the supporter will provide them with a review of their progress and interactions with the platform 6 times over the 8 week supported period.
Intervention: Behavioral: Space from Diabetes
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||August 10, 2018|
|Actual Primary Completion Date||July 15, 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||25 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT03077997|
|Other Study ID Numbers ICMJE||ICBTDIABETES|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Derek Richards, Silver Cloud Health|
|Study Sponsor ICMJE||Derek Richards|
|PRS Account||Silver Cloud Health|
|Verification Date||September 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP