DepressionPhase 2/3NCT01482806
Online Treatments for Mood and Anxiety Disorders in Primary Care
A Phase 2/3 study testing CCBT+ISG/Collaborative Care and CCBT/Collaborative Care in people with Depression and Generalized Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- CCBT+ISG/Collaborative Care and CCBT/Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 30 May 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 Years of age.
- 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.
Who cannot join
- Active suicidal ideation or psychotic disorder.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.
Read the detailed description
Depression and anxiety are prevalent in primary care practice, associated with substantial reductions in health-related quality of life (HRQoL), and generate a significant excess of morbidity. In response, dozens of trials have demonstrated the greater effectiveness of "Collaborative Care" for these conditions vs. primary care physicians' usual care. Yet for a variety of reasons, these models have not been widely implemented. Therefore, an urgent need remains to develop and test more scalable, powerful, and innovative versions of Collaborative Care while simultaneously developing a greater understanding of how best to provide these interventions through primary care where the majority of depressed and anxious patients seek treatment.
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
- Depression, Generalized Anxiety Disorder, Panic Disorder
- Being tested
- CCBT+ISG/Collaborative Care, CCBT/Collaborative Care
- Keywords
- Depression, Anxiety, Primary care, Cognitive Behavioral Therapy, Internet, Support groups, Technology assisted
- Medical subject headings
- Depression, Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCBT+ISG/Collaborative CareBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized CBT + Internet Support Group | Experimental | 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). Receives: Behavioral: CCBT+ISG/Collaborative Care |
| Computerized CBT Alone | Experimental | 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). Receives: Behavioral: CCBT/Collaborative Care |
| Usual Care | No intervention | Primary care physicians' "usual care" for mood and anxiety disorders (UC; N=100). |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12 MCS
The investigators will assess all study patients' mental health-related quality of life (HRQoL) on the SF-12 MCS via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.
Measured: 6-Month Follow-up
Secondary outcomes (6)
Hamilton Rating Scale for Depression
The investigators will assess all study patients' mood symptoms using the HRS-D via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.
Measured: 6-Months
Hamilton Rating Scale for Anxiety
Measured: 6-Months
WHO Health and Work Performance Questionnaire
Measured: 6-Months
Health Services Utilization and Costs
Measured: 12-Months
Attitudes to Computerized CBT
Measured: 6-Months
Computerized CBT and Internet Support Group Usage
Measured: 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Bruce Rollman, University of Pittsburgh
- Investigators
- Bruce L. Rollman, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482806
- Sponsor's protocol ID
- R01MH093501
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2011
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24817281Herbeck 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.
PubMed 25592159Jonassaint 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.
PubMed 28058109Cavanagh 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.
PubMed 30135755Rollman 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.
PubMed 29117275Geramita 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.
PubMed 30021711Jonassaint 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.
PubMed 31745855Rollman 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.
PubMed 31705476Rotondi 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.
PubMed 38231552Morone 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.
PubMed 34267085
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Treatments for Mood and Anxiety Disorders in Primary Care
- ClinicalTrials.gov ID
- NCT01482806
- Acronym / sponsor ID
- R01MH093501
- Conditions
- Depression, Generalized Anxiety Disorder, Panic Disorder
- Keywords
- Depression, Anxiety, Primary care, Cognitive Behavioral Therapy, Internet, Support groups, Technology assisted
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.
Detailed description
Depression and anxiety are prevalent in primary care practice, associated with substantial reductions in health-related quality of life (HRQoL), and generate a significant excess of morbidity. In response, dozens of trials have demonstrated the greater effectiveness of "Collaborative Care" for these conditions vs. primary care physicians' usual care. Yet for a variety of reasons, these models have not been widely implemented. Therefore, an urgent need remains to develop and test more scalable, powerful, and innovative versions of Collaborative Care while simultaneously developing a greater understanding of how best to provide these interventions through primary care where the majority of depressed and anxious patients seek treatment.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computerized CBT + Internet Support Group | Experimental | Behavioral: CCBT+ISG/Collaborative CareGuided 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). |
| Computerized CBT Alone | Experimental | Behavioral: CCBT/Collaborative CareGuided 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). |
| Usual Care | No intervention | –Primary care physicians' "usual care" for mood and anxiety disorders (UC; N=100). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 Years of age.
- 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.
Key exclusion criteria (5 listed)
- Active suicidal ideation or psychotic disorder.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCBT+ISG/Collaborative CareGuided 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. | Behavioural | Computerized CBT + Internet Support Group |
| CCBT/Collaborative CareGuided 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. | Behavioural | Computerized CBT Alone |
Primary outcome
SF-12 MCS
Time frame: 6-Month Follow-up
The investigators will assess all study patients' mental health-related quality of life (HRQoL) on the SF-12 MCS via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.
6 secondary outcomes
Hamilton Rating Scale for Depression
Time frame: 6-Months
Hamilton Rating Scale for Anxiety
Time frame: 6-Months
WHO Health and Work Performance Questionnaire
Time frame: 6-Months
Health Services Utilization and Costs
Time frame: 12-Months
Attitudes to Computerized CBT
Time frame: 6-Months
Computerized CBT and Internet Support Group Usage
Time frame: 12-Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Background: PubMed 24817281Rollman 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.
- Background: PubMed 25592159Herbeck 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.
- Background: PubMed 28058109Jonassaint 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.
- Background: PubMed 30135755Cavanagh 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.
- Background: PubMed 29117275Rollman 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.
- Background: PubMed 30021711Geramita 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.
- Background: PubMed 31745855Jonassaint 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.
- Background: PubMed 31705476Rollman 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.
- Derived from this study: PubMed 38231552Rotondi 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.
- Derived from this study: PubMed 34267085Morone 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce L. Rollman, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CCBT+ISG/Collaborative Care and CCBT/Collaborative Care in people with Depression and Generalized Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-12 MCS (time frame: 6-Month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482806, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.