iCBT for Long-term Conditions in IAPT

NCT03068286 | Terminated

• 1 other identifier: IAPTLTC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Chronic Pain; COPD; CHD - Coronary Heart Disease; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Diabetes Distress (As measured by the Diabetes Distress Scale)

  Baseline (week 0) and end of treatment (week 8)

• Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)

  Baseline (week 0) and end of treatment (week 8)

• Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)

  Baseline (week 0) and end of treatment (week 8)

• Quality of Life (As measured by the EuroQOL 5D5L)

  Baseline (week 0) and end of treatment (week 8)

• Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)

  Baseline (week 0) and end of treatment (week 8)

Study Arms (3)

Space in Diabetes

EXPERIMENTAL

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

Space in COPD

EXPERIMENTAL

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

Space in Chronic Pain

EXPERIMENTAL

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

Interventions

Space in Diabetes BEHAVIORAL

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.

Space in Diabetes

Space in COPD BEHAVIORAL

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.

Space in COPD

Space in Chronic Pain BEHAVIORAL

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.

Space in Chronic Pain

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derek Richards: lead

Study Sites (1)

Barnet, Enfield, and harringey Mental Health Trust

Enfield, EN2 0JB, United Kingdom

Location

Related Publications (17)

• 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

• 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.

  PMID: 22466510 BACKGROUND

• 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.

  PMID: 20183695 BACKGROUND

• 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.

  PMID: 17826170 BACKGROUND

• 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.

  BACKGROUND

• Coventry PA, Hays R, Dickens C, Bundy C, Garrett C, Cherrington A, Chew-Graham C. Talking about depression: a qualitative study of barriers to managing depression in people with long term conditions in primary care. BMC Fam Pract. 2011 Mar 22;12:10. doi: 10.1186/1471-2296-12-10.

  PMID: 21426542 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

• 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.

  PMID: 19208291 BACKGROUND

• Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.

  PMID: 15735199 BACKGROUND

• Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.

  PMID: 18474888 BACKGROUND

• McCracken, L. M., Vowels, K. E., & Eccleston, C. (2004). The chronic pain acceptance questionnaire. Pain, 107(1), 271-277.

  BACKGROUND

• Reda AA, Kotz D, Kocks JW, Wesseling G, van Schayck CP. Reliability and validity of the clinical COPD questionniare and chronic respiratory questionnaire. Respir Med. 2010 Nov;104(11):1675-82. doi: 10.1016/j.rmed.2010.04.023. Epub 2010 Jun 11.

  PMID: 20538445 BACKGROUND

• van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003 Apr 28;1:13. doi: 10.1186/1477-7525-1-13.

  PMID: 12773199 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• 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.

  PMID: 11983645 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Pain; Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Derek Richards, PD

  SilverCloud Health

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)