DepressionICBT@STEP3NCT03062202
Internet-delivered Cognitive Behaviour Therapy at Step 3 of IAPT
A study testing SilverCloud in people with Depression and Anxiety, run by Derek Richards at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- SilverCloud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2016to 25 Sep 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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;
- Can SilverCloud achieve positive clinical outcomes for patients?
- Will patients experience the online intervention as satisfactory?
- Can an online intervention for depression and anxiety realise cost saving benefits?
- Do clinicians find the experience of delivering the intervention as satisfactory (usable and acceptable)?
- 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.
- Conditions
- Depression, Anxiety
- Being tested
- SilverCloud
- Keywords
- Depression, Anxiety, Online interventions, CBT, IAPT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverCloudBehavioural
SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).
| Study group | Role | What they receive |
|---|---|---|
| Depression group | Experimental | SilverCloud iCBT for depression. Receives: Behavioral: SilverCloud |
| Anxiety group | Experimental | SilverCloud iCBT anxiety disorders. Receives: Behavioral: SilverCloud |
| Comorbid Depression and Anxiety group | Experimental | SilverCloud iCBT for comorbid depression and anxiety. Receives: Behavioral: SilverCloud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire)
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: Baseline and post-treatment - 8 weeks
Changes in anxiety symptoms (as measured by the 7 item Generalised Anxiety Disorder inventory)
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 (Richards \& Suckling, 2009).
Measured: Baseline and post-treatment - 8 weeks
Secondary outcomes (11)
Work and Social Adjustment
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 and post-treatment - 8 weeks
Social Phobia
Social Phobia Inventory (SPIN, Connor et al., 2000) consists of 17 self-rated items for social anxiety disorder. The test user is required to reflect over the past week and report on their experiences as laid out by the inventory, which assess the domains of social anxiety disorder (fear, avoidance and physiological arousal). Scores are then totaled to produce a value that is representative of symptom severity on a continuum from none to very severe. Internal reliability for the SPIN has been placed at α = .95, with α values for the subscales ranging from .79 - .85.
Measured: Baseline and post-treatment - 8 weeks
Obsessive Compulsive Tendencies
Obsessive-Compulsive Inventory (OCI, Foa et al., 1998) consists of 42 items and 7 subscales, including checking, doubting, washing, ordering, obsessing, hoarding and mental neutralising. Items are presented on a likert scale ranging from 0 (not at all) to 4 (extremely). In total, this scale provides 8 summary scores (7 for the subscales and an overall distress score) and these are represented by mean values. Reliability coefficients for the full scale are placed between .86 - .95 and reliability exceeds .70 for all subscales.
Measured: Baseline and post-treatment - 8 weeks
Heath Anxiety
Short Health Anxiety Inventory (Salkovskis, 2002) measures levels of health anxiety, which is characterized by the misinterpretation of bodily sensations as a serious illness. The shortened version of the scale has been constructed such that it is sensitive to both normal and severe levels of health anxiety. A meta-analysis of the inventory has yielded alpha values between .74 - .96 (Alberts et al., 2013).
Measured: Baseline and post-treatment - 8 weeks
Avoidance Behaviours
Mobility Inventory for Agoraphobia (Chambless et al., 1985) is a scale that was developed in order to measure the avoidance behaviours that are associated with agoraphobia. The α coefficients for both components of the scale are high, with the avoidance alone component yielding α= .96 and avoidance accompanied yielding α = .95 (Chambless et al., 2011)
Measured: Baseline and post-treatment - 8 weeks
Responses to Traumatic Events
Revised Impact of Events Scale (Weiss \& Marmar, 1997) is a measure that is typically used with a geriatric population. It looks at typical responses to traumatic events in the domains of intrusion, avoidance, hyperarousal and subjective stress. Full scale reliability analysis yielded α= .96, α= .94 for intrusion, α= .87 for avoidance and α= .91 for hyperarousal (Creamer, Bell \& Failla, 2003).
Measured: Baseline and post-treatment - 8 weeks
Patient Experience
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: At the end of the treatment - week 8
Therapeutic Alliance for patients
STAR-P (McGuire-Snieckus, et al., 2007) will be employed to assess patients experience of the therapeutic relationship online. It will be administered post-session.
Measured: continuous during treatment after each session for 8 weeks
Usability and Acceptability of the iCBT platforms for clinicians.
Usability \& Acceptability Questionnaire: At post intervention, the clinicians will be asked to answer open-ended questions regarding their experience that will be administered in an online format. The questions will be formatted into two sections, where the first will consist of items concerning the administration of the programme, and the second will have items examining the process of clinical support online.
Measured: At the end of the treatment 2 months
Therapeutic Alliance for clinicians
STAR-C (McGuire-Snieckus, et al., 2007) will be employed to assess clinicians experience of the therapeutic relationship online. The measure will be administered each time the clinician writes a review for their clients.
Measured: continuous during treatment after each session for 8 weeks
Qualitative Investigation into Therapeutic Alliance for Clinicians
Semi-structured interview: In addition a sample of clinicians will be invited to take part in a more in-depth interview that will consider key psychological aspect to online delivery of therapy and the nature of the therapeutic relationship online. The interview will be semi-structured and follow a number of key questions that will be developed from the extant literature on therapeutic alliance.
Measured: 1 month post study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start12 Dec 2016
- Primary completion25 Sep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derek Richards
- Sponsor type
- University, hospital or other
- Collaborators
- Silver Cloud Health, University of Dublin, Trinity College
- Responsible party
- Sponsor-investigator, Derek Richards, Silver Cloud Health
- Investigators
- Derek Richards, PhD, Study director, SilverCloud HealthJackie Allt, PhD, Principal investigator, Sussex Community NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062202
- Sponsor's protocol ID
- ICBT@STEP3
- Acronym
- ICBT@STEP3
- Status last verified
- May 2018
- First submitted
- 11 Feb 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12813115Richards 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.
PubMed 21820991National 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.
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.
PubMed 23872702Clark 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.
PubMed 22026487National Institute for Clinical Excellence. (2009). The treatment and management of depression in adults (pp. 64). London: UK: National Institute for Clinical Excellence.
Layard, R. (2006). The depression report: A new deal for depression and anxiety disorders (No. 15). Centre for Economic Performance, LSE.
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.
PubMed 17076960Proudfoot 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.
PubMed 15231555Richards 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 20183695Kroenke 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 10568646American Psychiatric Association (2000). Diagnostic and statistical manual of mental disorders (4th ed., Text Revision). Washington, DC.
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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03062202
- Acronym / sponsor ID
- ICBT@STEP3 / ICBT@STEP3
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Online interventions, CBT, IAPT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Derek RichardsUniversity, hospital or other
- Collaborators
- Silver Cloud Health, University of Dublin, Trinity College
- Study start
- 12 Dec 2016
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 23 Feb 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.
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;
- Can SilverCloud achieve positive clinical outcomes for patients?
- Will patients experience the online intervention as satisfactory?
- Can an online intervention for depression and anxiety realise cost saving benefits?
- Do clinicians find the experience of delivering the intervention as satisfactory (usable and acceptable)?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depression group | Experimental | Behavioral: SilverCloudSilverCloud iCBT for depression. |
| Anxiety group | Experimental | Behavioral: SilverCloudSilverCloud iCBT anxiety disorders. |
| Comorbid Depression and Anxiety group | Experimental | Behavioral: SilverCloudSilverCloud iCBT for comorbid depression and anxiety. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| SilverCloudSilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015). | Behavioural | Anxiety group, Comorbid Depression and Anxiety group, Depression group |
Primary outcome
Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire)
Time frame: Baseline and post-treatment - 8 weeks
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).
Changes in anxiety symptoms (as measured by the 7 item Generalised Anxiety Disorder inventory)
Time frame: Baseline and post-treatment - 8 weeks
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 (Richards \& Suckling, 2009).
11 secondary outcomes
Work and Social Adjustment
Time frame: Baseline and post-treatment - 8 weeks
Social Phobia
Time frame: Baseline and post-treatment - 8 weeks
Obsessive Compulsive Tendencies
Time frame: Baseline and post-treatment - 8 weeks
Heath Anxiety
Time frame: Baseline and post-treatment - 8 weeks
Avoidance Behaviours
Time frame: Baseline and post-treatment - 8 weeks
Responses to Traumatic Events
Time frame: Baseline and post-treatment - 8 weeks
Patient Experience
Time frame: At the end of the treatment - week 8
Therapeutic Alliance for patients
Time frame: continuous during treatment after each session for 8 weeks
Usability and Acceptability of the iCBT platforms for clinicians.
Time frame: At the end of the treatment 2 months
Therapeutic Alliance for clinicians
Time frame: continuous during treatment after each session for 8 weeks
Qualitative Investigation into Therapeutic Alliance for Clinicians
Time frame: 1 month post study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 12813115Kessler 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.
- Background: PubMed 21820991Richards 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.
- BackgroundNational 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.
- Background: PubMed 23872702Gyani 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.
- Background: PubMed 22026487Clark 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.
- BackgroundNational Institute for Clinical Excellence. (2009). The treatment and management of depression in adults (pp. 64). London: UK: National Institute for Clinical Excellence.
- BackgroundLayard, R. (2006). The depression report: A new deal for depression and anxiety disorders (No. 15). Centre for Economic Performance, LSE.
- Background: PubMed 17076960Cavanagh 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.
- Background: PubMed 15231555Proudfoot 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.
- 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 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.
- Individual participant dataSharing planned: No
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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, PhD study director
SilverCloud Health
Jackie Allt, PhD principal investigator
Sussex Community NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SilverCloud in people with Depression and Anxiety, 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 5 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: finished, as of the sponsor's last update on 11 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire) (time frame: Baseline and post-treatment - 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 NCT03062202, which also lists 27 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 May 2018.