DiabetesNCT03068286
iCBT for Long-term Conditions in IAPT
A study testing Space in Diabetes, Space in COPD and Space in Chronic Pain in people with Diabetes and Chronic Pain, run by Derek Richards at 1 site in United Kingdom.
Trial summary
SilverCloud provides internet-delivered interventions for depression and anxiety in NHS Mental Health Services. The interventions have proved successful in the management of depression and anxiety for clients presenting to mental health services, with recovery rates exceeding the national standard. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Diabetes, Chronic Pain, COPD
- What is being tested?
- Space in Diabetes, Space in COPD and Space in Chronic Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- English language speakers
- Have capacity to consent
- Has a chronic condition (Diabetes, COPD, Chronic Pain) with comorbid depression and/or anxiety.
- Suitable for step 2 intervention in NHS IAPT Services.
Who cannot join
- Exceed cut-off score for risk in terms of self-harm on the screening questionnaires.
- Receiving an intervention (therapeutic or biological) that is not a part of treatment as usual, or another trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barnet, Enfield, and harringey Mental Health Trust
Enfield, EN2 0JB
About this study
Official title: Tailored Internet-delivered Cognitive Behavioural Therapy for Depression and Anxiety in Patients With a Long-term Condition (Chronic Pain, COPD and Diabetes).
SilverCloud provides internet-delivered interventions for depression and anxiety in NHS Mental Health Services. The interventions have proved successful in the management of depression and anxiety for clients presenting to mental health services, with recovery rates exceeding the national standard. Recently SilverCloud has embarked on tailoring the interventions for patients with long-term conditions including COPD, pain and diabetes. The purpose of the customisation is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the possible effectiveness of implementing customised internet-delivered interventions for depression and anxiety for people with long-term conditions presenting to NHS mental health services.
Read the detailed description
iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety (Richards \& Richardson, 2012; Andersson and Cuijpers, 2009). Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered from poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option (Richards et al., 2015).
Chronic illnesses can have profound effects on well-being, functional capacity and quality of life. Psychological comorbidities with an LTC can further contribute to the distress that is caused by these symptoms. Patients with comorbid depression and anxiety disorders and a long-term condition are associated with significantly higher health care utilisation, poorer outcomes from treatment and increased costs of care (Moussavi et al., 2007; Naylor et al., 2012). The IAPT programme in the UK provides effective treatments for depression and anxiety but these have been underutilized by people with LTCs and partially this is due to an underrecognition; one reason for this has been the traditional precedence set on managing the physical aspects of any LTC and effectively paying little attention to psychological comorbidity (Coventry et al., 2011).
Several pathfinders sites are currently involved in providing psychological treatment for long-term conditions, but to date, results have been limited due to several factors, such as delays in commencing programmes and funding issues. To this extent, SilverCloud wishes to implement their tailored "Space from…" series of programmes for long-term conditions - chronic pain, COPD and Diabetes. The purpose of the tailoring is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the clinical feasibility of implementing customised internet-delivered interventions for depression and anxiety for people with LTCS presenting to IAPT services.
- Conditions
- Diabetes, Chronic Pain, COPD, CHD - Coronary Heart Disease, Depression, Anxiety
- Being tested
- Space in Diabetes, Space in COPD, Space in Chronic Pain
- Medical subject headings
- Diabetes Mellitus, Chronic Pain, Pulmonary Disease, Chronic Obstructive, Coronary Artery Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space in DiabetesBehavioural
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes.
Space in COPDBehavioural
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored.Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety.
Space in Chronic PainBehavioural
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled "Anxiety and your Health", has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain.
| Study group | Role | What they receive |
|---|---|---|
| Space in Diabetes | Experimental | The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes. Receives: Behavioral: Space in Diabetes |
| Space in COPD | Experimental | The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety. Receives: Behavioral: Space in COPD |
| Space in Chronic Pain | Experimental | The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled "Anxiety and your Health", has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain. Receives: Behavioral: Space in Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression (as measured by the Patient Health Questionnaire)
The 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).
Measured: Weekly for up to 8 weeks
Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)
The 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 (D. A. Richards \& Suckling, 2009).
Measured: Weekly for up to 8 weeks
Secondary outcomes (6)
Diabetes Distress (As measured by the Diabetes Distress Scale)
The Diabetes Distress Scale (DDS; Polonsky et al., 2005; Fisher et al., 2008) is a 17-item measure that focusses 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, exerecise and total cholesterol (Polonsky et al., 2005).
Measured: Baseline (week 0) and end of treatment (week 8)
Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)
The Chronic Pain Acceptance Questionnaire (Revised) (CPAQ-R; McCracken, Vowles \& Eccleston, 2004) is a 20 item measure used to assess acceptance of pain in chronic pain patients and contains two subscales - activity engagement and pain willingness. The measure has demonstrated good levels of internal consistency (α = .80)
Measured: Baseline (week 0) and end of treatment (week 8)
Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)
The Clinical COPD Questionnaire (CCQ; Reda et al., 2010; Molen et al., 2003) is a 10 item measure that incorporates three subscales - symptoms, functional state and mental state. Each item is graded on a 7-point likert scale, where lower scores are indicative of a better COPD health status. Internal consistency of the measure has been found to be good (α = .91) (Molen et al., 2003)
Measured: Baseline (week 0) and end of treatment (week 8)
Quality of Life (As measured by the EuroQOL 5D5L)
The EuroQol 5D5L (EQ5D5L) (Herdman et al., 2011) is a measure of health-related quality of life. The first part of the measure consists of 5 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.
Measured: Baseline (week 0) and end of treatment (week 8)
Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)
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.
Measured: Baseline (week 0) and end of treatment (week 8)
Patient Experience (As measured by the Patient Experience Questionnaire)
The Patient Experience Questionnaire will be used to assess patient experience and satisfaction. This questionnaire forms a part of the IAPT minimum data set and is a national requirement in the UK. The PEQ contains several quantitative questions and open ended questions that are used to assess participant's views and satisfaction with service provision.
Measured: End of treatment (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derek Richards
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Derek Richards, Silver Cloud Health
- Investigators
- Derek Richards, PD, Study director, SilverCloud Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068286
- Sponsor's protocol ID
- IAPTLTC
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.
PubMed 26523885Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
PubMed 22466510Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
PubMed 20183695Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
PubMed 17826170Naylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M., & Galea, A. (2012). Long-term conditions and mental health: the cost of co-morbidities. London, UK: The King's Fund.
Coventry PA, Hays R, Dickens C, Bundy C, Garrett C, Cherrington A, Chew-Graham C. Talking about depression: a qualitative study of barriers to managing depression in people with long term conditions in primary care. BMC Fam Pract. 2011 Mar 22;12:10. doi: 10.1186/1471-2296-12-10.
PubMed 21426542Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Richards DA, Suckling R. Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol. 2009 Nov;48(Pt 4):377-96. doi: 10.1348/014466509X405178. Epub 2009 Feb 9.
PubMed 19208291Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
PubMed 15735199Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
PubMed 18474888McCracken, L. M., Vowels, K. E., & Eccleston, C. (2004). The chronic pain acceptance questionnaire. Pain, 107(1), 271-277.
Reda AA, Kotz D, Kocks JW, Wesseling G, van Schayck CP. Reliability and validity of the clinical COPD questionniare and chronic respiratory questionnaire. Respir Med. 2010 Nov;104(11):1675-82. doi: 10.1016/j.rmed.2010.04.023. Epub 2010 Jun 11.
PubMed 20538445van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003 Apr 28;1:13. doi: 10.1186/1477-7525-1-13.
PubMed 12773199
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Internet-delivered Cognitive Behavioural Therapy for Depression and Anxiety in Patients With a Long-term Condition (Chronic Pain, COPD and Diabetes).
- ClinicalTrials.gov ID
- NCT03068286
- Acronym / sponsor ID
- IAPTLTC
- Conditions
- Diabetes, Chronic Pain, COPD, CHD - Coronary Heart Disease, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Derek RichardsUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SilverCloud provides internet-delivered interventions for depression and anxiety in NHS Mental Health Services. The interventions have proved successful in the management of depression and anxiety for clients presenting to mental health services, with recovery rates exceeding the national standard. Recently SilverCloud has embarked on tailoring the interventions for patients with long-term conditions including COPD, pain and diabetes. The purpose of the customisation is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the possible effectiveness of implementing customised internet-delivered interventions for depression and anxiety for people with long-term conditions presenting to NHS mental health services.
Detailed description
iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety (Richards \& Richardson, 2012; Andersson and Cuijpers, 2009). Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered from poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option (Richards et al., 2015).
Chronic illnesses can have profound effects on well-being, functional capacity and quality of life. Psychological comorbidities with an LTC can further contribute to the distress that is caused by these symptoms. Patients with comorbid depression and anxiety disorders and a long-term condition are associated with significantly higher health care utilisation, poorer outcomes from treatment and increased costs of care (Moussavi et al., 2007; Naylor et al., 2012). The IAPT programme in the UK provides effective treatments for depression and anxiety but these have been underutilized by people with LTCs and partially this is due to an underrecognition; one reason for this has been the traditional precedence set on managing the physical aspects of any LTC and effectively paying little attention to psychological comorbidity (Coventry et al., 2011).
Several pathfinders sites are currently involved in providing psychological treatment for long-term conditions, but to date, results have been limited due to several factors, such as delays in commencing programmes and funding issues. To this extent, SilverCloud wishes to implement their tailored "Space from…" series of programmes for long-term conditions - chronic pain, COPD and Diabetes. The purpose of the tailoring is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the clinical feasibility of implementing customised internet-delivered interventions for depression and anxiety for people with LTCS presenting to IAPT services.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Space in Diabetes | Experimental | Behavioral: Space in DiabetesThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes. |
| Space in COPD | Experimental | Behavioral: Space in COPDThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety. |
| Space in Chronic Pain | Experimental | Behavioral: Space in Chronic PainThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled "Anxiety and your Health", has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age
- English language speakers
- Have capacity to consent
- Has a chronic condition (Diabetes, COPD, Chronic Pain) with comorbid depression and/or anxiety.
- Suitable for step 2 intervention in NHS IAPT Services.
Key exclusion criteria (2 listed)
- Exceed cut-off score for risk in terms of self-harm on the screening questionnaires.
- Receiving an intervention (therapeutic or biological) that is not a part of treatment as usual, or another trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Space in DiabetesThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes. | Behavioural | Space in Diabetes |
| Space in COPDThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored.Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety. | Behavioural | Space in COPD |
| Space in Chronic PainThe SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled "Anxiety and your Health", has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain. | Behavioural | Space in Chronic Pain |
Primary outcome
Depression (as measured by the Patient Health Questionnaire)
Time frame: Weekly for up to 8 weeks
The 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: Weekly for up to 8 weeks
The 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 (D. A. Richards \& Suckling, 2009).
6 secondary outcomes
Diabetes Distress (As measured by the Diabetes Distress Scale)
Time frame: Baseline (week 0) and end of treatment (week 8)
Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)
Time frame: Baseline (week 0) and end of treatment (week 8)
Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)
Time frame: Baseline (week 0) and end of treatment (week 8)
Quality of Life (As measured by the EuroQOL 5D5L)
Time frame: Baseline (week 0) and end of treatment (week 8)
Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)
Time frame: Baseline (week 0) and end of treatment (week 8)
Patient Experience (As measured by the Patient Experience Questionnaire)
Time frame: End of treatment (week 8)
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 26523885Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.
- Background: PubMed 22466510Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
- Background: PubMed 20183695Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
- Background: PubMed 17826170Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
- BackgroundNaylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M., & Galea, A. (2012). Long-term conditions and mental health: the cost of co-morbidities. London, UK: The King's Fund.
- Background: PubMed 21426542Coventry PA, Hays R, Dickens C, Bundy C, Garrett C, Cherrington A, Chew-Graham C. Talking about depression: a qualitative study of barriers to managing depression in people with long term conditions in primary care. BMC Fam Pract. 2011 Mar 22;12:10. doi: 10.1186/1471-2296-12-10.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 19208291Richards DA, Suckling R. Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol. 2009 Nov;48(Pt 4):377-96. doi: 10.1348/014466509X405178. Epub 2009 Feb 9.
- Background: PubMed 15735199Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
- Background: PubMed 18474888Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Individual participant dataSharing planned: No
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Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Richards, PD study director
SilverCloud Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space in Diabetes, Space in COPD and Space in Chronic Pain in people with Diabetes and Chronic Pain, run by Derek Richards at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (as measured by the Patient Health Questionnaire) (time frame: Weekly for up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068286, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.