Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)
NCT ID: NCT03068676
Last Updated: 2018-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
12 participants
INTERVENTIONAL
2017-02-08
2018-02-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Online Treatments for Mood and Anxiety Disorders in Primary Care
NCT01482806
Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress
NCT02614443
iCBT for Seniors With Depression in Primary Care
NCT06537869
Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.
NCT03500536
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
NCT01591720
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. Is the model of implementation (screening, recruitment, and adherence to the internet-delivered intervention) feasible?
2. Will patients experience the iCBT intervention as satisfactory within their primary care treatment?
3. What is the feedback of the Primary Care Practitioners about the implementation of the internet-delivered intervention as part of primary care?
4. What is the experience of the trained supporters who assist patients within the iCBT intervention?
5. Can an internet-delivered intervention achieve improvements in depressive and anxiety symptoms for users?
6. Can patient attitudes toward internet-delivered interventions predict treatment outcome?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Space from depression
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 Depression
internet-delivered CBT
Space from Anxiety
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.
Space from Anxiety
internet-delivered CBT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Space from Depression
internet-delivered CBT
Space from Anxiety
internet-delivered CBT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Summa Health System
OTHER
Silver Cloud Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Derek Richards, PhD
Role: STUDY_DIRECTOR
SilverCloud Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Summa Health
Akron, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Khouzam, H. R. (2009). Anxiety Disorders: Guidelines for Effective Primary Care, Part 1, Diagnosis. Consultant, 49 (3).
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.
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.
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.
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.
Lepine JP. The epidemiology of anxiety disorders: prevalence and societal costs. J Clin Psychiatry. 2002;63 Suppl 14:4-8.
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.
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.
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.
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.
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.
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.
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.
Sheehan DV. Depression: underdiagnosed, undertreated, underappreciated. Manag Care. 2004 Jun;13(6 Suppl Depression):6-8.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUMMA-PC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.