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Internet Intervention for Diabetes Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03077997
Recruitment Status : Terminated (logistics recruitment)
First Posted : March 13, 2017
Last Update Posted : September 11, 2018
Silver Cloud Health
University of Dublin, Trinity College
Information provided by (Responsible Party):
Derek Richards, Silver Cloud Health

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Space from Diabetes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability and Clinical Feasibility of an Internet-delivered Intervention for Psychological Distress in Patients With Type 2 Diabetes
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Depression (as measured by the Patient Health Questionnaire) [ Time Frame: At the end of treatment (week 8) ]
    Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Spitzer, Kroenke, & Williams, 1999) is a self-report measure of depression that has been widely used in screening, primary care, and research. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association [APA], 2000). Summary scores range from 0-27, where larger scores reflect a greater severity of depressive symptoms. The PHQ-9 has been found to discriminated well between depressed and non-depressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%), specificity (88.0%) and reliability (.89) (Kroenke et al., 2001; Spitzer et al., 1999).

  2. Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory) [ Time Frame: At the end of treatment (week 8) ]
    Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006) GAD-7 comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD. The GAD-7 has good internal consistency (α = .92) and good convergent validity with other anxiety scales (Spitzer et al., 2006). Higher scores indicate greater severity of symptoms. The GAD-7 has increasingly been used in large-scale studies as a generic measure of change in anxiety symptomatology, using a cut-off score of 8 (Richards & Suckling, 2009).

  3. Work and Social Adjustment [ Time Frame: At the end of treatment (week 8) ]
    Work and Social Adjustment (WASA; Mundt, Marks, Shear & Greist, 2002) is a simple, reliable and valid measure of impaired functioning. It is a simple and reliable (α >.75) 5-item self-report measure which provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships.

  4. Satisfaction with Treatment [ Time Frame: End of treatment (week 8) ]
    The Satisfaction with Treatment (SAT; Timulak & Richards, 2012) measure contains several questions that aim to assess patient satisfaction with the iCBT intervention received. The measure consists of two qualitative questions and several quantitative questions, centering on what the patients liked or disliked about the iCBT intervention.

  5. EuroQol 5D5L [ Time Frame: At the end of treatment (week 8) ]
    The EuroQol 5D5L (EQ5D5L) (Rabin, Oemar, Oppe, & on behalf of the EuroQoL Group, 2011) is a measure of health-related quality of life. The first part of the measure consists of five self-report items measuring the domains of mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each item has a possible five responses, which rank in severity (no problems - extreme problems). From these results, a societal index can be obtained, allowing for further analysis. The second part of the measure records self-reported health state on a visual analogue scale (VAS), a vertical line where the best and worst imaginable health states score 100 and 0, respectively.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03077997

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United Kingdom
Barnet, Enfield, and Haringey Mental Health Trust
Enfield, United Kingdom, EN2 0JB
Sponsors and Collaborators
Derek Richards
Silver Cloud Health
University of Dublin, Trinity College
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Study Director: Derek Richards, PhD SilverCloud Health

Feinglos, M. N., Bethel, M. A., & SpringerLink (Online service). (2008). Type 2 diabetes mellitus: An evidence-based approach to practical management. Totowa, N.J: Humana Press, a part of Springer Science+Business Media, LLC.
Gebel, E. (2013). Diabetes distress. Diabetes Forecast. Retrieved from
Franz, M. J. (2007). Lifestyle interventions across the continuum of type 2 diabetes: reducing the risks of diabetes. American Journal of Lifestyle Medicine,1(5), 327-334
Centers for Disease Control and Prevention. (2011). National diabetes fact sheet, 2011 Retrieved from ndfs_2011.pdf.

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Responsible Party: Derek Richards, Director of Clinical Research and Innovation, Silver Cloud Health Identifier: NCT03077997    
Other Study ID Numbers: ICBTDIABETES
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Derek Richards, Silver Cloud Health:
Diabetes distress
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases