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iCBT for Long-term Conditions in IAPT

Primary Purpose

Diabetes, Chronic Pain, COPD

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Space in Diabetes
Space in COPD
Space in Chronic Pain
Sponsored by
Derek Richards
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Barnet, Enfield, and harringey Mental Health Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Space in Diabetes

Space in COPD

Space in Chronic Pain

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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)
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)
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.
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.
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.

Full Information

First Posted
February 16, 2017
Last Updated
September 7, 2018
Sponsor
Derek Richards
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1. Study Identification

Unique Protocol Identification Number
NCT03068286
Brief Title
iCBT for Long-term Conditions in IAPT
Official Title
Tailored Internet-delivered Cognitive Behavioural Therapy for Depression and Anxiety in Patients With a Long-term Condition (Chronic Pain, COPD and Diabetes).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Derek Richards

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Chronic Pain, COPD, CHD - Coronary Heart Disease, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Space in Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
Space in COPD
Arm Type
Experimental
Arm Description
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.
Arm Title
Space in Chronic Pain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Space in Diabetes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Space in COPD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Space in Chronic Pain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression (as measured by the Patient Health Questionnaire)
Description
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).
Time Frame
Weekly for up to 8 weeks
Title
Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)
Description
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).
Time Frame
Weekly for up to 8 weeks
Secondary Outcome Measure Information:
Title
Diabetes Distress (As measured by the Diabetes Distress Scale)
Description
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).
Time Frame
Baseline (week 0) and end of treatment (week 8)
Title
Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)
Description
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)
Time Frame
Baseline (week 0) and end of treatment (week 8)
Title
Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)
Description
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)
Time Frame
Baseline (week 0) and end of treatment (week 8)
Title
Quality of Life (As measured by the EuroQOL 5D5L)
Description
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.
Time Frame
Baseline (week 0) and end of treatment (week 8)
Title
Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)
Description
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.
Time Frame
Baseline (week 0) and end of treatment (week 8)
Title
Patient Experience (As measured by the Patient Experience Questionnaire)
Description
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.
Time Frame
End of treatment (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Richards, PD
Organizational Affiliation
SilverCloud Health
Official's Role
Study Director
Facility Information:
Facility Name
Barnet, Enfield, and harringey Mental Health Trust
City
Enfield
ZIP/Postal Code
EN2 0JB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26523885
Citation
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.
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Citation
Richards 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.
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20183695
Citation
Andersson 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.
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Citation
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iCBT for Long-term Conditions in IAPT

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