iCBT for Long-term Conditions in IAPT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tailored Internet-delivered Cognitive Behavioural Therapy for Depression and Anxiety in Patients With a Long-term Condition (Chronic Pain, COPD and Diabetes).

Conditions
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COPD, Diabetes, Chronic Pain, CHD - Coronary Heart Disease, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Space in Diabetes
* Behavioral: Space in COPD
* Behavioral: Space in Chronic Pain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Space in Diabetes<br>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. | Behavioral: Space in Diabetes<br>* 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.<br>|
| Experimental: Space in COPD<br>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. | Behavioral: Space in COPD<br>* 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.<br>|
| Experimental: Space in Chronic Pain<br>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. | Behavioral: Space in Chronic Pain<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Weekly for up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 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) | 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. | 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. | 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. | End of treatment (week 8) |