Clinical trial NCT03068286: 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
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Chronic Pain
COPD
CHD - Coronary Heart Disease
Depression
Anxiety
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression (as measured by the Patient Health Questionnaire)
timeFrame: Weekly for up to 8 weeks
measure: Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)
timeFrame: Weekly for up to 8 weeks
Secondary outcomes:
measure: Diabetes Distress (As measured by the Diabetes Distress Scale)
timeFrame: Baseline (week 0) and end of treatment (week 8)
measure: Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)
timeFrame: Baseline (week 0) and end of treatment (week 8)
measure: Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)
timeFrame: Baseline (week 0) and end of treatment (week 8)
measure: Quality of Life (As measured by the EuroQOL 5D5L)
timeFrame: Baseline (week 0) and end of treatment (week 8)
measure: Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)
timeFrame: Baseline (week 0) and end of treatment (week 8)
measure: Patient Experience (As measured by the Patient Experience Questionnaire)
timeFrame: End of treatment (week 8)
Other outcomes:
Locations:
city: Enfield
country: United Kingdom
facility: Barnet, Enfield, and harringey Mental Health Trust
Study officials:
affiliation: SilverCloud Health
name: Derek Richards, PD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: Moussavi 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.
citation: Naylor, 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.
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