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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Space from Diabetes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03077997
|Barnet, Enfield, and Haringey Mental Health Trust|
|Enfield, United Kingdom, EN2 0JB|
|Study Director:||Derek Richards, PhD||SilverCloud Health|