NCT03077997

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

February 20, 2017

Last Update Submit

September 7, 2018

Conditions

Diabetes

Keywords

DiabetesDiabetes distress

Outcome Measures

Primary Outcomes (1)

  • Diabetes Distress (As measured by the Diabetes Distress Scale)

    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).

    At the end of treatment (week 8)

Secondary Outcomes (5)

  • Depression (as measured by the Patient Health Questionnaire)

    At the end of treatment (week 8)

  • Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)

    At the end of treatment (week 8)

  • Work and Social Adjustment

    At the end of treatment (week 8)

  • Satisfaction with Treatment

    End of treatment (week 8)

  • EuroQol 5D5L

    At the end of treatment (week 8)

Study Arms (1)

Space from Diabetes

EXPERIMENTAL

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

Interventions

Space from DiabetesBEHAVIORAL

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.

Space from Diabetes

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnet, Enfield, and Haringey Mental Health Trust

Enfield, EN2 0JB, United Kingdom

Location

Related Publications (17)

  • Torpy JM, Golub RM. JAMA patient page. Diabetes. JAMA. 2011 Jun 22;305(24):2592. doi: 10.1001/jama.2011.741. No abstract available.

    PMID: 21693751BACKGROUND

  • 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.

    BACKGROUND

  • Golden SH, Lazo M, Carnethon M, Bertoni AG, Schreiner PJ, Diez Roux AV, Lee HB, Lyketsos C. Examining a bidirectional association between depressive symptoms and diabetes. JAMA. 2008 Jun 18;299(23):2751-9. doi: 10.1001/jama.299.23.2751.

    PMID: 18560002BACKGROUND

  • Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Diabetes Educ. 2015 Aug;41(4):417-30. doi: 10.1177/0145721715588904. Epub 2015 Jun 5. No abstract available.

    PMID: 26047627BACKGROUND

  • Kok JL, Williams A, Zhao L. Psychosocial interventions for people with diabetes and co-morbid depression. A systematic review. Int J Nurs Stud. 2015 Oct;52(10):1625-39. doi: 10.1016/j.ijnurstu.2015.05.012. Epub 2015 Jun 6.

    PMID: 26118440BACKGROUND

  • Grigsby AB, Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. Prevalence of anxiety in adults with diabetes: a systematic review. J Psychosom Res. 2002 Dec;53(6):1053-60. doi: 10.1016/s0022-3999(02)00417-8.

    PMID: 12479986BACKGROUND

  • Fisher L, Mullan JT, Skaff MM, Glasgow RE, Arean P, Hessler D. Predicting diabetes distress in patients with Type 2 diabetes: a longitudinal study. Diabet Med. 2009 Jun;26(6):622-7. doi: 10.1111/j.1464-5491.2009.02730.x.

    PMID: 19538238BACKGROUND

  • Gebel, E. (2013). Diabetes distress. Diabetes Forecast. Retrieved from http://www.diabetes.org/living-with-diabetes/complications/mental-health/diabetes-distress.html

    BACKGROUND

  • Nam S, Chesla C, Stotts NA, Kroon L, Janson SL. Barriers to diabetes management: patient and provider factors. Diabetes Res Clin Pract. 2011 Jul;93(1):1-9. doi: 10.1016/j.diabres.2011.02.002. Epub 2011 Mar 5.

    PMID: 21382643BACKGROUND

  • Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. doi: 10.2337/diacare.25.7.1159.

    PMID: 12087014BACKGROUND

  • Strine TW, Okoro CA, Chapman DP, Beckles GL, Balluz L, Mokdad AH. The impact of formal diabetes education on the preventive health practices and behaviors of persons with type 2 diabetes. Prev Med. 2005 Jul;41(1):79-84. doi: 10.1016/j.ypmed.2004.10.009. Epub 2004 Nov 19.

    PMID: 15916996BACKGROUND

  • 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

    BACKGROUND

  • Pal K, Eastwood SV, Michie S, Farmer AJ, Barnard ML, Peacock R, Wood B, Inniss JD, Murray E. Computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD008776. doi: 10.1002/14651858.CD008776.pub2.

    PMID: 23543567BACKGROUND

  • Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.

    PMID: 12610059BACKGROUND

  • Centers for Disease Control and Prevention. (2011). National diabetes fact sheet, 2011 Retrieved from http://www.cdc.gov/diabetes/pubs/pdf/ ndfs_2011.pdf.

    BACKGROUND

  • Myung SK, McDonnell DD, Kazinets G, Seo HG, Moskowitz JM. Effects of Web- and computer-based smoking cessation programs: meta-analysis of randomized controlled trials. Arch Intern Med. 2009 May 25;169(10):929-37. doi: 10.1001/archinternmed.2009.109.

    PMID: 19468084BACKGROUND

  • Cotter AP, Durant N, Agne AA, Cherrington AL. Internet interventions to support lifestyle modification for diabetes management: a systematic review of the evidence. J Diabetes Complications. 2014 Mar-Apr;28(2):243-51. doi: 10.1016/j.jdiacomp.2013.07.003. Epub 2013 Dec 12.

    PMID: 24332469BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Derek Richards, PhD

    SilverCloud Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Clinical Research and Innovation

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 13, 2017

Study Start

March 15, 2017

Primary Completion

July 15, 2018

Study Completion

August 10, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)