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Internet Intervention for Diabetes Distress

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Derek Richards, Silver Cloud Health
Sponsor:
Collaborators:
Silver Cloud Health
University of Dublin, Trinity College
Information provided by (Responsible Party):
Derek Richards, Silver Cloud Health
ClinicalTrials.gov Identifier:
NCT03077997
First received: February 20, 2017
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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 Intervention
Diabetes Behavioral: Space from Diabetes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Acceptability and Clinical Feasibility of an Internet-delivered Intervention for Psychological Distress in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Derek Richards, Silver Cloud Health:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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).

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 42
Actual Study Start Date: March 15, 2017
Estimated Study Completion Date: December 10, 2017
Estimated Primary Completion Date: September 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03077997

Contacts
Contact: Caroline Earley, MSc +353 1 554 9767 caroline.earley@silvercloudhealth.com
Contact: Daniel Duffy, MSc +353 1 554 9767 daniel.duffy@silvercloudhealth.com

Locations
United Kingdom
Barnet, Enfield, and Haringey Mental Health Trust Recruiting
Enfield, United Kingdom, EN2 0JB
Contact: Jack MCGOURAN       jack.mcgouran@nhs.net   
Sponsors and Collaborators
Derek Richards
Silver Cloud Health
University of Dublin, Trinity College
Investigators
Study Director: Derek Richards, PhD SilverCloud Health
  More Information

Publications:
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 http://www.diabetes.org/living-with-diabetes/complications/mental-health/diabetes-distress.html
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 http://www.cdc.gov/diabetes/pubs/pdf/ ndfs_2011.pdf.

Responsible Party: Derek Richards, Director of Clinical Research and Innovation, Silver Cloud Health
ClinicalTrials.gov Identifier: NCT03077997     History of Changes
Other Study ID Numbers: ICBTDIABETES
Study First Received: February 20, 2017
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Diabetes distress

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2017