Clinical trial NCT03062202: Internet-delivered Cognitive Behaviour Therapy at Step 3 of IAPT
Official title: The Potential Impact of Using Internet-delivered CBT (iCBT) for People in IAPT Services as a Prequel to High Intensity Therapy (HIT) for Depression and Anxiety Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Depression
Anxiety
Online interventions
CBT
IAPT
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
Collaborators: name: Silver Cloud Health
name: University of Dublin, Trinity College
First posted: 2017-02-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will explore the potential impacts of internet-delivered cognitive behavioural therapy (ICBT) at step 3 of the IAPT model. To do this, interventions administered as a prequel to face-to-face therapy will be analysed and compared based on their impacts in regards to access, outcomes (psychological) and costs. A qualitative segment will also be conducted in order to investigate the acceptability and usability of the platform for clinicians and the possibility of developing a therapeutic alliance through an online medium.

Detailed description: Depression and anxiety disorders (panic disorder, social anxiety disorder, specific phobias and generalized anxiety disorder) have been ranked high among the leading causes of disease burden throughout the world, displaying high rates of lifetime incidence, early age onset, high chronicity, and role impairment. Depression and anxiety are associated with impairment in several areas of functioning including social, occupational and personal. The cost to the person and the economy is great, for instance, 105 billion pounds is the estimated cost of depression in the UK with 30% of that being consumed through occupational costs. This has consequently had to be augmented through unemployment benefit to the tune of 7-10 billion.

Improving Access to Psychological Therapies (IAPT):

In 2007 the Department of Health UK announced the introduction of the Improving Access to Psychological Therapies (IAPT) programme. The aim of the programme was to extend access to clinically approved psychological interventions for depression and anxiety. In doing this, the hope was to be able to tackle and help alleviate the burden of psychological distress and its associated costs. In accordance with the model, a five-step approach to psychological care for people with depression and anxiety was introduced and implemented within NHS mental health services The model can be interpreted as a hierarchical care model of mental health, where each step is catered to provide treatment based on the severity of symptoms presented by the patient. This includes watchful waiting by general practitioners care at step 1, step 2 relates to low-intensity psychological interventions, step 3 involves high-intensity psychological interventions, step 4 comprises of specialist mental health care, and step 5 consists of inpatient treatment for mental health problems.

The use of cCBT in IAPT As recommended by the National Institute for Health and Clinical Excellence the IAPT programme offers computerised cognitive behaivoural therapy (cCBT) as a low-intensity, Step 2 intervention for individuals presenting with mild to moderate symptoms of depression and/or anxiety. cCBT and internet-delivered cognitive behavior therapy (iCBT) are delivered by PWPs and support is offered through electronic communication means or by telephone support. However, traditionally they have often suffered with 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 increase engagement, enhance productivity, and produce better clinical effectiveness. In accordance with what has been utilised in the IAPT model, research has demonstrated the effectiveness of cCBT and iCBT in treating symptoms of depression and anxiety . There is now a substantial body of research evidence that supports the efficacy and effectiveness of online delivered cognitive behavior therapy for depression and anxiety.

Alongside the use of antidepressants, patients at Step 3 IAPT are commonly treated using face-to-face psychological interventions include cognitive behavior therapy, interpersonal therapy, and behavioural activation. In practice, online delivered interventions have been used in some cases for those at step 3 and also as a facilitator for those who are stepping down from Step 3. However, to date, there have not been studies conducted that have examined the potential of online interventions at step 3 and their impact on access rates, clinical and functional outcomes, and costs.

Methodology Objective of the trial To explore the potential of using internet-delivered CBT (iCBT) for people in IAPT services as a prequel to high intensity therapy (HIT) for depression and anxiety disorders.

Research Questions The objective can be further dismantled into;

1. Can SilverCloud achieve positive clinical outcomes for patients?
2. Will patients experience the online intervention as satisfactory?
3. Can an online intervention for depression and anxiety realise cost saving benefits?
4. Do clinicians find the experience of delivering the intervention as satisfactory (usable and acceptable)?
5. Can a therapeutic alliance be established online?

Design The current study will be a mixed methods, uncontrolled feasibility design. The study will utilise both patient and clinician participants. For patients, the study will examine quantitatively clinical outcomes for patients in regards to depression and anxiety, functional outcomes in terms of work and social functioning and cost effectiveness in regards to step-3 services. Therapeutic alliance will also be examined using both patient and clinician participants. Qualitatively, patient satisfaction and clinician experience of the usability and acceptability of the online intervention will be explored. The study will also qualitatively explore the nature of the therapeutic alliance online through use of a semi-structured interview with clinician participants.

Eligibility criteria: INCLUSION CRITERIA

* Deemed suitable for an initial Step 3 intervention at IAPT.
* 18 years old and above.
* Able to read English.
* Have capacity to consent.
* Willing to consent.

EXCLUSION CRITERIA

* Flag a risk as per IAPT regulations. (e.g. indicating self-harm on the PHQ-9)
* Receiving an intervention or treatment that is not a part of TAU or another trial.
* Specific communication needs.
* Screened and require an intervention for traumatic stress.
* Do not meet the requirements for step 3 treatment.

Primary outcomes:
measure: Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire)
timeFrame: Baseline and post-treatment - 8 weeks
measure: Changes in anxiety symptoms (as measured by the 7 item Generalised Anxiety Disorder inventory)
timeFrame: Baseline and post-treatment - 8 weeks
Secondary outcomes:
measure: Work and Social Adjustment
timeFrame: Baseline and post-treatment - 8 weeks
measure: Social Phobia
timeFrame: Baseline and post-treatment - 8 weeks
measure: Obsessive Compulsive Tendencies
timeFrame: Baseline and post-treatment - 8 weeks
measure: Heath Anxiety
timeFrame: Baseline and post-treatment - 8 weeks
measure: Avoidance Behaviours
timeFrame: Baseline and post-treatment - 8 weeks
measure: Responses to Traumatic Events
timeFrame: Baseline and post-treatment - 8 weeks
measure: Patient Experience
timeFrame: At the end of the treatment - week 8
measure: Therapeutic Alliance for patients
timeFrame: continuous during treatment after each session for 8 weeks
measure: Usability and Acceptability of the iCBT platforms for clinicians.
timeFrame: At the end of the treatment 2 months
measure: Therapeutic Alliance for clinicians
timeFrame: continuous during treatment after each session for 8 weeks
measure: Qualitative Investigation into Therapeutic Alliance for Clinicians
timeFrame: 1 month post study.
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Sussex Community NHS Trust
Study officials:
affiliation: SilverCloud Health
name: Derek Richards, PhD
role: STUDY_DIRECTOR
affiliation: Sussex Community NHS Trust
name: Jackie Allt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
citation: Richards D. Prevalence and clinical course of depression: a review. Clin Psychol Rev. 2011 Nov;31(7):1117-25. doi: 10.1016/j.cpr.2011.07.004. Epub 2011 Jul 23.
citation: National Institute for Health and Clinical Excellence. (2006). Computerised cognitive behaviour therapy for depression and anxiety. Technology Appraisal 97. London: National Institute for Health and Clinical Excellence.
citation: Gyani A, Shafran R, Layard R, Clark DM. Enhancing recovery rates: lessons from year one of IAPT. Behav Res Ther. 2013 Sep;51(9):597-606. doi: 10.1016/j.brat.2013.06.004. Epub 2013 Jul 4.
citation: Clark DM. Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. Int Rev Psychiatry. 2011 Aug;23(4):318-27. doi: 10.3109/09540261.2011.606803.
citation: National Institute for Clinical Excellence. (2009). The treatment and management of depression in adults (pp. 64). London: UK: National Institute for Clinical Excellence.
citation: Layard, R. (2006). The depression report: A new deal for depression and anxiety disorders (No. 15). Centre for Economic Performance, LSE.
citation: Cavanagh K, Shapiro DA, Van Den Berg S, Swain S, Barkham M, Proudfoot J. The effectiveness of computerized cognitive behavioural therapy in routine care. Br J Clin Psychol. 2006 Nov;45(Pt 4):499-514. doi: 10.1348/014466505X84782.
citation: Proudfoot J, Ryden C, Everitt B, Shapiro DA, Goldberg D, Mann A, Tylee A, Marks I, Gray JA. Clinical efficacy of computerised cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:46-54. doi: 10.1192/bjp.185.1.46.
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: Kroenke 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.
citation: Spitzer 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.
citation: American Psychiatric Association (2000). Diagnostic and statistical manual of mental disorders (4th ed., Text Revision). Washington, DC.
citation: Spitzer 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.
citation: Richards 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.
citation: Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
citation: Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
citation: Foa, E. B., Kozak, M. J., Salkovskis, P. M., Coles, M. E., & Amir, N. (1998). The validation of a new obsessive-compulsive disorder scale: The Obsessive-Compulsive Inventory. Psychological Assessment, 10(3), 206.
citation: Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
citation: Alberts NM, Hadjistavropoulos HD, Jones SL, Sharpe D. The Short Health Anxiety Inventory: a systematic review and meta-analysis. J Anxiety Disord. 2013 Jan;27(1):68-78. doi: 10.1016/j.janxdis.2012.10.009. Epub 2012 Nov 9.
citation: Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35-44. doi: 10.1016/0005-7967(85)90140-8. No abstract available.
citation: Chambless DL, Sharpless BA, Rodriguez D, McCarthy KS, Milrod BL, Khalsa SR, Barber JP. Psychometric properties of the mobility inventory for agoraphobia: convergent, discriminant, and criterion-related validity. Behav Ther. 2011 Dec;42(4):689-99. doi: 10.1016/j.beth.2011.03.001. Epub 2011 May 24.
citation: Weiss, D. S., & Marmar, C. R. (1997). The impact of event scale-revised. Assessing psychological trauma and PTSD, 2, 168-189.
citation: Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.
citation: McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
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.