Online Treatments for Mood and Anxiety Disorders in Primary Care
NCT ID: NCT01482806
Last Updated: 2020-08-05
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.
COMPLETED
PHASE2/PHASE3
700 participants
INTERVENTIONAL
2012-02-29
2017-05-30
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.
Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method
NCT07028216
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
NCT01591720
Collaborative Care for Treatment of Depression and Anxiety
NCT06556589
Acceptability and Clinical, Cognitive and Brain Efficacy of the Pilot of a Computerized Psychotherapy Program Based on Behavioural and Cognitive Techniques in the Depressed Patient
NCT04152421
Health Care Workers and Mental Health
NCT05028075
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Thousands of web sites provide medical information and the number of Internet support groups (ISG) where the public can exchange information about treatments is proliferating. Still, clinical trials have not established the benefits of utilizing the Internet in this manner. Concurrent with these developments, several computerized cognitive behavioral therapy (CCBT) programs have been proven effective at treating patients with mood and anxiety disorders and used by hundreds of thousands of patients outside the U.S. Yet CCBT remains little utilized inside the U.S., and no trials have incorporated CCBT into a Collaborative Care intervention or examined the effectiveness of combining CCBT with an ISG for these disorders.
We propose a 4-year comparative effectiveness trial that will randomize 700 primary care patients aged 18-75 who have at least a moderate level of mood and/or anxiety symptoms and reliable access to both the Internet and e-mail to either: (1) guided patient access to Beating the Blues, a proven-effective on-line CCBT program (CCBT-alone; N=300); (2) guided patient access to Beating the Blues plus access to a moderated ISG (CCBT+ISG; N=300); or (3) their PCP's "usual care" (N=100). Our primary hypothesis is that patients in our CCBT+ISG arm will report a clinically meaningful 0.30 effect size (ES) or greater improvement in HRQoL on the SF-12 MCS compared to patients in our CCBT-alone arm at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions. Our secondary hypothesis is that CCBT-alone patients will report a 0.50 ES or greater improvement in HRQoL on the SF-12 MCS versus "usual care" at 6-months follow-up. To better understand how online mental health treatments are best provided through primary care, we will also evaluate: (a) their effectiveness across and within age strata; (b) their cost-effectiveness; (c) how patients utilize the components of our interventions; (d) patient subgroups for whom our interventions may be particularly effective; and (e) the adoption and maintenance of our interventions by practices following the Intervention Phase of the Project. Study findings are likely to have profound implications for transforming the way mental health conditions are treated in primary care and focus further attention to the emerging field of e-mental health by other U.S. investigators.
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.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Computerized CBT + Internet Support Group
Guided patient access to Beating the Blues plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants (CCBT+ISG; N=300).
CCBT+ISG/Collaborative Care
Guided patient access to the Beating the Blues CCBT program plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants
These interventions will be delivered as part of a collaborative care intervention provided in concert with their usual source of primary care.
Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
Computerized CBT Alone
Guided patient access to Beating the Blues, a proven-effective, on-line 8-session CCBT program approved for use in the United Kingdom (CCBT-alone; N=300).
CCBT/Collaborative Care
Guided patient access to the Beating the Blues CCBT program.
This interventions will be provided as part of a collaborative care intervention provided in concert with their usual source of primary care.
Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
Usual Care
Primary care physicians' "usual care" for mood and anxiety disorders (UC; N=100).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CCBT+ISG/Collaborative Care
Guided patient access to the Beating the Blues CCBT program plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants
These interventions will be delivered as part of a collaborative care intervention provided in concert with their usual source of primary care.
Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
CCBT/Collaborative Care
Guided patient access to the Beating the Blues CCBT program.
This interventions will be provided as part of a collaborative care intervention provided in concert with their usual source of primary care.
Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current major depression, panic, and/or generalized anxiety disorder on PRIME-MD.
* At least a moderate level of mood and/or anxiety symptoms (PHQ-9 ≥ 10 or a GAD-7 ≥ 10).
* Not receiving treatment for a mood or anxiety disorder from a mental health specialist.
* Has a telephone, e-mail address, and reliable access to the Internet.
* Stable medical condition and life expectancy greater than one year.
Exclusion Criteria
* History of bipolar disorder.
* Alcohol dependence or other substance abuse disorder within the past three months.
* Plans to leave present source of care over the following year.
* Non-English speaking, illiterate, or having a visual or auditory barrier limiting ability to participate in telephone assessments, interventions, or provide signed, informed consent.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bruce Rollman
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruce L. Rollman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 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.
Rollman BL, Herbeck Belnap B, Rotondi AJ. Internet support groups for health: ready for the Affordable Care Act. J Gen Intern Med. 2014 Nov;29(11):1436-8. doi: 10.1007/s11606-014-2884-z. No abstract available.
Herbeck Belnap B, Schulberg HC, He F, Mazumdar S, Reynolds CF 3rd, Rollman BL. Electronic protocol for suicide risk management in research participants. J Psychosom Res. 2015 Apr;78(4):340-5. doi: 10.1016/j.jpsychores.2014.12.012. Epub 2014 Dec 27.
Jonassaint CR, Gibbs P, Belnap BH, Karp JF, Abebe KK, Rollman BL. Engagement and outcomes for a computerised cognitive-behavioural therapy intervention for anxiety and depression in African Americans. BJPsych Open. 2017 Jan 2;3(1):1-5. doi: 10.1192/bjpo.bp.116.003657. eCollection 2017 Jan.
Cavanagh K, Herbeck Belnap B, Rothenberger SD, Abebe KZ, Rollman BL. My care manager, my computer therapy and me: The relationship triangle in computerized cognitive behavioural therapy. Internet Interv. 2017 Nov 6;11:11-19. doi: 10.1016/j.invent.2017.10.005. eCollection 2018 Mar.
Rollman BL, Herbeck Belnap B, Abebe KZ, Spring MB, Rotondi AJ, Rothenberger SD, Karp JF. Effectiveness of Online Collaborative Care for Treating Mood and Anxiety Disorders in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Jan 1;75(1):56-64. doi: 10.1001/jamapsychiatry.2017.3379.
Geramita EM, Herbeck Belnap B, Abebe KZ, Rothenberger SD, Rotondi AJ, Rollman BL. The Association Between Increased Levels of Patient Engagement With an Internet Support Group and Improved Mental Health Outcomes at 6-Month Follow-Up: Post-Hoc Analyses From a Randomized Controlled Trial. J Med Internet Res. 2018 Jul 17;20(7):e10402. doi: 10.2196/10402.
Jonassaint CR, Belnap BH, Huang Y, Karp JF, Abebe KZ, Rollman BL. Racial Differences in the Effectiveness of Internet-Delivered Mental Health Care. J Gen Intern Med. 2020 Feb;35(2):490-497. doi: 10.1007/s11606-019-05542-1. Epub 2019 Nov 19.
Rollman BL, Brent DA. Phonotype: a New Taxonomy for mHealth Research. J Gen Intern Med. 2020 Jun;35(6):1881-1883. doi: 10.1007/s11606-019-05407-7. Epub 2019 Nov 8. No abstract available.
Rotondi AJ, Belnap BH, Rothenberger S, Feldman R, Hanusa B, Rollman BL. Predictors of Use and Drop Out From a Web-Based Cognitive Behavioral Therapy Program and Health Community for Depression and Anxiety in Primary Care Patients: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2024 Jan 17;11:e52197. doi: 10.2196/52197.
Morone NE, Herbeck BB, Huang Y, Abebe KZ, Rollman BL, Jonassaint CR. The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms. Psychosom Med. 2021 Nov-Dec 01;83(9):1067-1074. doi: 10.1097/PSY.0000000000000980.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.