Internet-delivered Cognitive Behaviour Therapy at Step 3 of IAPT

NCT03062202 | Completed DMC

• 1 other identifier: ICBT@STEP3
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Depression; Anxiety; Online interventions; CBT; IAPT

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline and post-treatment - 8 weeks

Secondary Outcomes (11)

• Work and Social Adjustment

  Baseline and post-treatment - 8 weeks

• Social Phobia

  Baseline and post-treatment - 8 weeks

• Obsessive Compulsive Tendencies

  Baseline and post-treatment - 8 weeks

• Heath Anxiety

  Baseline and post-treatment - 8 weeks

• Avoidance Behaviours

  Baseline and post-treatment - 8 weeks

Study Arms (3)

Depression group

EXPERIMENTAL

SilverCloud iCBT for depression.

Behavioral: SilverCloud

Anxiety group

EXPERIMENTAL

SilverCloud iCBT anxiety disorders.

Behavioral: SilverCloud

Comorbid Depression and Anxiety group

EXPERIMENTAL

SilverCloud iCBT for comorbid depression and anxiety.

Behavioral: SilverCloud

Interventions

SilverCloud BEHAVIORAL

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).

Anxiety group; Comorbid Depression and Anxiety group; Depression group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derek Richards: lead
• Silver Cloud Health: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Sussex Community NHS Trust

Brighton, RH12 2DR, United Kingdom

Location

Related Publications (27)

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• 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.

  PMID: 21820991 BACKGROUND

• 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.

  BACKGROUND

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• National Institute for Clinical Excellence. (2009). The treatment and management of depression in adults (pp. 64). London: UK: National Institute for Clinical Excellence.

  BACKGROUND

• Layard, R. (2006). The depression report: A new deal for depression and anxiety disorders (No. 15). Centre for Economic Performance, LSE.

  BACKGROUND

• 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.

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  PMID: 20183695 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 10568646 BACKGROUND

• American Psychiatric Association (2000). Diagnostic and statistical manual of mental disorders (4th ed., Text Revision). Washington, DC.

  BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

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• 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.

  BACKGROUND

• 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.

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  PMID: 17094819 BACKGROUND

• 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.

  PMID: 26523885 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Derek Richards, PhD

  SilverCloud Health

  STUDY DIRECTOR

• Jackie Allt, PhD

  Sussex Community NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research and Innovation

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 23, 2017
• Study Start: December 12, 2016
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)