Not provided
Not provided
Not provided
Not provided
Not provided
Paused due to technical issues
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Summa Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
The current study is an open feasibility trial with the aim of providing a description of the factors associated with the implementation of an iCBT platform into an existing treatment framework in a primary care setting. The trial will examine the factors surrounding implementation, such as the experience of primary care practitioners and the online supporters, the recruitment process, and attitudes towards the overall implementation of the interventions. Patients presenting to the primary care setting will be screened using standard depression and anxiety measures, and where appropriate, will be referred to an iCBT intervention for either depression or anxiety, with support from trained staff. Analyses will be conducted on outcome measures to examine changes in symptom severity as patients progress through the intervention. Patient satisfaction data will also be collected to establish patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at Ohio Family Practice Center]
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. Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, 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 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.
Approximately 90% of primary care patients with depression have one or more visits to a primary care physician (PCP) over a 12-month period, whereas less than one-third see a mental health professional. It has been reported that individuals with an anxiety disorder are 3 to 5 times more likely to visit their primary care physician than those without, but their symptoms are often associated with physical causes. PCPs often do not have training in psychological therapies and therefore they do not feel competent to treat individuals presenting with depression or anxiety. Often these individuals are prescribed antidepressant or anti-anxiety medications.
The use of online programs to deliver CBT to people with mental health disorders is becoming increasingly popular. Internet-delivered CBT (iCBT) consists of programs designed for the treatment of specific disorders, such as depression and anxiety, which are delivered via the internet. These programs can be clinician-guided and/or self-administered interventions. Evidence suggests that iCBT can benefit individuals with anxiety and depression when offered in a service context that offers brief support from trained staff. Such iCBT interventions are widely-used in some European countries and the recommended length of treatment is generally 6 - 8 online sessions. A robust evidence base supporting the use and effectiveness of internet-delivered treatments for depression and anxiety has been established. Outcomes have been greater for those programs offering the additional feature of human support.
The current study will examine the feasibility of implementing an iCBT platform within a primary care setting. This objective can be further dismantled into several sub objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Space from depression | Experimental | Space from Depression is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material. |
|
| Space from Anxiety | Experimental | Space from Anxiety is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Space from Depression | Behavioral | internet-delivered CBT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient health Questionnaire | The PHQ-9 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). Summed scores range from 0-27; larger scores reflect a greater severity of depressive symptoms. The PHQ-9 discriminated well between depressed and nondepressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%) and specificity (88.0%) (Kroenke et al., 2001; R. Spitzer et al., 1999). | At week 8 |
| Generalized Anxiety Disorder | The GAD-7 (Spitzer, Krownke, Williams, & Lowe, 2006) 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 (.89) and good convergent validity with other anxiety scales. Higher scores indicate greater severity of symptoms. The GAD-7 is increasingly used in large-scale studies as a generic measure of changes in anxiety symptomatology, using a cut-off score of 8 (Richards & Suckling, 2009). | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-demographic Questionnaire | Collects information on the characteristics of the sample including age, gender etc. | At baseline for screening |
| Work and Social Adjustment | The 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 that 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. |
Not provided
Inclusion criteria:
At least 18 years of age, Speak English, Self-report symptoms of depression or anxiety (using PHQ-9 and GAD-7 measures).
Specifically for the self-report symptoms,
participants will need to have a PHQ-9 score of 5 to 19 for the depression program or a GAD-7 score of 5 to 15 for the anxiety program.
Participants currently attending face-to-face therapy/counseling will be excluded.
Exclusion criteria
Participants who flag as a risk on the self-harm item of the PHQ-9 during routine office visit screening will not be referred to the study and will be provided treatment and/or referral services as per the clinic's standard procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Derek Richards, PhD | SilverCloud Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summa Health | Akron | Ohio | 44310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20183695 | 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. | |
| 7926703 | Background | Coyne JC, Fechner-Bates S, Schwenk TL. Prevalence, nature, and comorbidity of depressive disorders in primary care. Gen Hosp Psychiatry. 1994 Jul;16(4):267-76. doi: 10.1016/0163-8343(94)90006-x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Space from Anxiety |
| Behavioral |
internet-delivered CBT |
|
| At baseline and week 8 |
| Satisfaction with Treatment | The Satisfaction with Treatment (SAT; Timulak & Richards, 2012) measure contains several questions that aim to assess patient satisfaction with the iCBT intervention received. The measure consists of 2 qualitative questions and several quantitative questions, centring on what the patients liked or disliked about the iCBT intervention. | At week 8 |
| Attitudes towards Psychological Online Interventions | The Attitudes towards Psychological Online Interventions (APOI; Schroder et al., 2015) will be administered to patients at both pre and post intervention time points. The APOI is a brief inventory that assesses attitudes towards online interventions across four domains - scepticism and perception of risks, confidence in effectiveness, technologization threat and anonymity benefits. | At baseline and week 8 |
| 17695343 | Background | Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. |
| 10491249 | Background | Goldman LS, Nielsen NH, Champion HC. Awareness, diagnosis, and treatment of depression. J Gen Intern Med. 1999 Sep;14(9):569-80. doi: 10.1046/j.1525-1497.1999.03478.x. |
| 23252357 | Background | Hedman E, Ljotsson B, Lindefors N. Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):745-64. doi: 10.1586/erp.12.67. |
| 12470125 | Background | Katon WJ, Roy-Byrne P, Russo J, Cowley D. Cost-effectiveness and cost offset of a collaborative care intervention for primary care patients with panic disorder. Arch Gen Psychiatry. 2002 Dec;59(12):1098-104. doi: 10.1001/archpsyc.59.12.1098. |
| 8279933 | Background | Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002. |
| Background | Khouzam, H. R. (2009). Anxiety Disorders: Guidelines for Effective Primary Care, Part 1, Diagnosis. Consultant, 49 (3). |
| 15640922 | Background | Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14. |
| 11556941 | 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. |
| 17339617 | Background | Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004. |
| 19698625 | Background | Lecrubier Y, Weiller E. Characteristics, recognition and treatment of dysthymics in primary care. Eur Psychiatry. 1998 Jul;13(4):198-202. doi: 10.1016/S0924-9338(98)80004-7. |
| 12562112 | Background | Lepine JP. The epidemiology of anxiety disorders: prevalence and societal costs. J Clin Psychiatry. 2002;63 Suppl 14:4-8. |
| 10203638 | Background | Lyness JM, Caine ED, King DA, Cox C, Yoediono Z. Psychiatric disorders in older primary care patients. J Gen Intern Med. 1999 Apr;14(4):249-54. doi: 10.1046/j.1525-1497.1999.00326.x. |
| 20127795 | Background | Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, Reifler D. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010 Apr;66(4):394-409. doi: 10.1002/jclp.20659. |
| 24725765 | Background | Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109. |
| 22466510 | 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. |
| 26523885 | 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. |
| 19208291 | 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. |
| 10207741 | Background | Schulberg HC, Mulsant B, Schulz R, Rollman BL, Houck PR, Reynolds CF 3rd. Characteristics and course of major depression in older primary care patients. Int J Psychiatry Med. 1998;28(4):421-36. doi: 10.2190/G23R-NGGN-K1P1-MQ8N. |
| 15293765 | Background | Sheehan DV. Depression: underdiagnosed, undertreated, underappreciated. Manag Care. 2004 Jun;13(6 Suppl Depression):6-8. |
| 10228889 | Background | Simon GE, Goldberg D, Tiemens BG, Ustun TB. Outcomes of recognized and unrecognized depression in an international primary care study. Gen Hosp Psychiatry. 1999 Mar-Apr;21(2):97-105. doi: 10.1016/s0163-8343(98)00072-3. |
| 17112400 | Background | Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20. |
| 10568646 | 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. |
| 16717171 | 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. |
| 7966923 | Background | Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56. |
| 10936633 | Background | Stein MB, McQuaid JR, Pedrelli P, Lenox R, McCahill ME. Posttraumatic stress disorder in the primary care medical setting. Gen Hosp Psychiatry. 2000 Jul-Aug;22(4):261-9. doi: 10.1016/s0163-8343(00)00080-3. |
| 21977354 | Background | Vermani M, Marcus M, Katzman MA. Rates of detection of mood and anxiety disorders in primary care: a descriptive, cross-sectional study. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01013. doi: 10.4088/PCC.10m01013. |
| 15939840 | Background | Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629-40. doi: 10.1001/archpsyc.62.6.629. |
| 10320115 | Background | Williams JW Jr, Mulrow CD, Kroenke K, Dhanda R, Badgett RG, Omori D, Lee S. Case-finding for depression in primary care: a randomized trial. Am J Med. 1999 Jan;106(1):36-43. doi: 10.1016/s0002-9343(98)00371-4. |