Clinical trial NCT03077997: Internet Intervention for Diabetes Distress
Official title: Acceptability and Clinical Feasibility of an Internet-delivered Intervention for Psychological Distress in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Diabetes distress
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
Collaborators: name: Silver Cloud Health
name: University of Dublin, Trinity College
First posted: 2017-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Design:

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.

Sample:

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.

Procedure:

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.

Ethical considerations:

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.

Eligibility criteria: Inclusion Criteria:

* Aged between 25-80.
* Have type 2 diabetes for five years or more.
* Have internet access

Exclusion Criteria:

* Outside of age criteria.
* Does not have type 2 diabetes for five years or more.
* No internet access

Primary outcomes:
measure: Diabetes Distress (As measured by the Diabetes Distress Scale)
timeFrame: At the end of treatment (week 8)
Secondary outcomes:
measure: Depression (as measured by the Patient Health Questionnaire)
timeFrame: At the end of treatment (week 8)
measure: Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)
timeFrame: At the end of treatment (week 8)
measure: Work and Social Adjustment
timeFrame: At the end of treatment (week 8)
measure: Satisfaction with Treatment
timeFrame: End of treatment (week 8)
measure: EuroQol 5D5L
timeFrame: At the end of treatment (week 8)
Other outcomes:
Locations:
city: Enfield
country: United Kingdom
facility: Barnet, Enfield, and Haringey Mental Health Trust
Study officials:
affiliation: SilverCloud Health
name: Derek Richards, PhD
role: STUDY_DIRECTOR
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