Post-traumatic Stress DisorderPhase 4NCT00347269
Primary Care Intervention Strategy for Anxiety Disorders
A Phase 4 study testing Cognitive-behavioral therapy, Psychotropic medication optimization and Treatment as Usual in people with Post-traumatic Stress Disorder and Generalized Anxiety Disorder, run by University of Washington at 4 sites in United States.
Trial summary
This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- Cognitive-behavioral therapy, Psychotropic medication optimization and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2006to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
- Speak English or Spanish (English only at UAMS site)
Who cannot join
- Diagnosis of Bipolar 1
- Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol
- Acute suicidality or homicidality
- Eligible subjects must be current patients at one of the participating primary care clinics which include:
- University of Washington:
- Harborview's Adult Medicine Clinic
Show all 26Show fewer
- Harborview's Family Medicine Clinic
- UWMC's General Internal Medicine Clinic at Roosevelt Clinic
- PSNHC's 45th Street Clinic
- Country Doctor Community Clinic
- Carolyn Downs Family Medical Center
- UCLA:
- Desert Medical Group, Palm Springs CA
- High Desert Medical Group, Lancaster, CA
- UCSD:
- Kaiser Permanente, Bonita Medical Offices
- Kaiser Permanente, Otay Mesa Outpatient Medical Center
- UCSD Medical Center, Scripps Ranch Medical Office
- UCSD Medical Center, Fourth and Lewis Medical Office
- UCSD Medical Center, Perlman Ambulatory Care Center
- Sharp Rees-Stealy Medical Group, El Cajon
- Sharp Rees-Stealy Medical Group, Mira Mesa
- UAMS:
- UAMS UPMG
- Little Rock Diagnostic Clinic
- St. Vincent's Family Clinic South
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of California
La Jolla, California, 92037-0603
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72114
University of California
Los Angeles, California, 90095-1563
University of Washington
Seattle, Washington, 98104
About this study
Official title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.
Read the detailed description
Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manager assisted chronic disease management program for four common anxiety disorders (post-traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder) in the primary care setting. This approach has been shown to be effective for the treatment of depression.
Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
- Conditions
- Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
- Being tested
- Cognitive-behavioral therapy, Psychotropic medication optimization, Treatment as Usual
- Keywords
- Anxiety Disorders, Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Stress, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Mental Health Disorders
- Medical subject headings
- Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Panic Disorder, Phobia, Social, Anxiety Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimizationDrug
Also called SSRI, SNRI, Benzodiazepine,
For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
Treatment as UsualBehavioural
Participants in the control group will receive standard treatment from their PCP.
| Study group | Role | What they receive |
|---|---|---|
| CALM Intervention | Experimental | Participant choice of:
Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization Receives: Behavioral: Cognitive-behavioral therapy; Drug: Psychotropic medication optimization |
| Treatment as Usual (TAU) | Active comparator | Participants assigned to TAU with their primary care provider (PCP) Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSI-12 (Anxiety and Somatization Subscales)
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Measured: Measured at Month 18
Secondary outcomes (1)
Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9
Measured: Measured at Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Peter Roy-Byrne, University of Washington
- Investigators
- Peter P. Roy-Byrne, MD, Principal investigator, University of WashingtonCathy D. Sherbourne, PhD, Principal investigator, RAND Corporation, Santa Monica, CAMichelle G. Craske, PhD, Principal investigator, University of California, Los AngelesGreer Sullivan, MD, MSPH, Principal investigator, University of Arkansas for Medical Sciences, Little Rock, ARMurray B. Stein, MD, MPH, Principal investigator, University of California, San Diego, San Diego, CAKristin Bumgardner, BS, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347269
- Sponsor's protocol ID
- 28630
- Other IDs
- U01MH057858-05, DSIR 83-ATAS
- Status last verified
- Apr 2017
- First submitted
- 30 Jun 2006
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Limited access datasets are available through the National Database for Clinical Trials Related to Mental Illness (NDCT), part of the NIMH Data Archive: https://data-archive.nimh.nih.gov/ndct/.
Publications
Lang AJ, Wilkins K, Roy-Byrne PP, Golinelli D, Chavira D, Sherbourne C, Rose RD, Bystritsky A, Sullivan G, Craske MG, Stein MB. Abbreviated PTSD Checklist (PCL) as a guide to clinical response. Gen Hosp Psychiatry. 2012 Jul-Aug;34(4):332-8. doi: 10.1016/j.genhosppsych.2012.02.003. Epub 2012 Mar 27.
PubMed 22460001Craske MG, Roy-Byrne PP, Stein MB, Sullivan G, Sherbourne C, Bystritsky A. Treatment for anxiety disorders: Efficacy to effectiveness to implementation. Behav Res Ther. 2009 Nov;47(11):931-7. doi: 10.1016/j.brat.2009.07.012. Epub 2009 Jul 14.
PubMed 19632667Roy-Byrne P, Veitengruber JP, Bystritsky A, Edlund MJ, Sullivan G, Craske MG, Welch SS, Rose R, Stein MB. Brief intervention for anxiety in primary care patients. J Am Board Fam Med. 2009 Mar-Apr;22(2):175-86. doi: 10.3122/jabfm.2009.02.080078.
PubMed 19264941Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.
PubMed 18486238Sullivan G, Craske MG, Sherbourne C, Edlund MJ, Rose RD, Golinelli D, Chavira DA, Bystritsky A, Stein MB, Roy-Byrne PP. Design of the Coordinated Anxiety Learning and Management (CALM) study: innovations in collaborative care for anxiety disorders. Gen Hosp Psychiatry. 2007 Sep-Oct;29(5):379-87. doi: 10.1016/j.genhosppsych.2007.04.005.
PubMed 17888803Brown LA, Krull JL, Roy-Byrne P, Sherbourne CD, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. An examination of the bidirectional relationship between functioning and symptom levels in patients with anxiety disorders in the CALM study. Psychol Med. 2015 Feb;45(3):647-61. doi: 10.1017/S0033291714002062. Epub 2014 Oct 2.
PubMed 25272965Brown LA, Wiley JF, Wolitzky-Taylor K, Roy-Byrne P, Sherbourne C, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. Changes in self-efficacy and outcome expectancy as predictors of anxiety outcomes from the CALM study. Depress Anxiety. 2014 Aug;31(8):678-89. doi: 10.1002/da.22256. Epub 2014 Mar 11.
PubMed 24619599Chavira DA, Golinelli D, Sherbourne C, Stein MB, Sullivan G, Bystritsky A, Rose RD, Lang AJ, Campbell-Sills L, Welch S, Bumgardner K, Glenn D, Barrios V, Roy-Byrne P, Craske M. Treatment engagement and response to CBT among Latinos with anxiety disorders in primary care. J Consult Clin Psychol. 2014 Jun;82(3):392-403. doi: 10.1037/a0036365. Epub 2014 Mar 24.
PubMed 24660674Dour HJ, Wiley JF, Roy-Byrne P, Stein MB, Sullivan G, Sherbourne CD, Bystritsky A, Rose RD, Craske MG. Perceived social support mediates anxiety and depressive symptom changes following primary care intervention. Depress Anxiety. 2014 May;31(5):436-42. doi: 10.1002/da.22216. Epub 2013 Dec 12.
PubMed 24338947Joesch JM, Golinelli D, Sherbourne CD, Sullivan G, Stein MB, Craske MG, Roy-Byrne PP. Trajectories of change in anxiety severity and impairment during and after treatment with evidence-based treatment for multiple anxiety disorders in primary care. Depress Anxiety. 2013 Nov;30(11):1099-106. doi: 10.1002/da.22149. Epub 2013 Jun 25.
PubMed 23801589Campbell-Sills L, Stein MB, Sherbourne CD, Craske MG, Sullivan G, Golinelli D, Lang AJ, Chavira DA, Bystritsky A, Rose RD, Welch SS, Kallenberg GA, Roy-Byrne P. Effects of medical comorbidity on anxiety treatment outcomes in primary care. Psychosom Med. 2013 Oct;75(8):713-20. doi: 10.1097/PSY.0b013e31829def54. Epub 2013 Jul 25.
PubMed 23886736Roy-Byrne P, Sullivan MD, Sherbourne CD, Golinelli D, Craske MG, Sullivan G, Stein MB. Effects of pain and prescription opioid use on outcomes in a collaborative care intervention for anxiety. Clin J Pain. 2013 Sep;29(9):800-6. doi: 10.1097/AJP.0b013e318278d475.
PubMed 23370069Bomyea J, Lang AJ, Craske MG, Chavira D, Sherbourne CD, Rose RD, Golinelli D, Campbell-Sills L, Welch SS, Sullivan G, Bystritsky A, Roy-Byrne P, Stein MB. Suicidal ideation and risk factors in primary care patients with anxiety disorders. Psychiatry Res. 2013 Aug 30;209(1):60-5. doi: 10.1016/j.psychres.2013.03.017. Epub 2013 Apr 19.
PubMed 23608160Glenn D, Golinelli D, Rose RD, Roy-Byrne P, Stein MB, Sullivan G, Bystritksy A, Sherbourne C, Craske MG. Who gets the most out of cognitive behavioral therapy for anxiety disorders? The role of treatment dose and patient engagement. J Consult Clin Psychol. 2013 Aug;81(4):639-649. doi: 10.1037/a0033403. Epub 2013 Jun 10.
PubMed 23750465Wetherell JL, Petkus AJ, Thorp SR, Stein MB, Chavira DA, Campbell-Sills L, Craske MG, Sherbourne C, Bystritsky A, Sullivan G, Roy-Byrne P. Age differences in treatment response to a collaborative care intervention for anxiety disorders. Br J Psychiatry. 2013 Jul;203(1):65-72. doi: 10.1192/bjp.bp.112.118547. Epub 2013 Apr 11.
PubMed 23580378
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
- ClinicalTrials.gov ID
- NCT00347269
- Acronym / sponsor ID
- 28630
- Conditions
- Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
- Keywords
- Anxiety Disorders, Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Stress, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.
Detailed description
Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manager assisted chronic disease management program for four common anxiety disorders (post-traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder) in the primary care setting. This approach has been shown to be effective for the treatment of depression.
Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALM Intervention | Experimental | Behavioral: Cognitive-behavioral therapy, Drug: Psychotropic medication optimizationParticipant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as UsualParticipants assigned to TAU with their primary care provider (PCP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
- Speak English or Spanish (English only at UAMS site)
Key exclusion criteria (26 listed)
- Diagnosis of Bipolar 1
- Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol
- Acute suicidality or homicidality
- Eligible subjects must be current patients at one of the participating primary care clinics which include:
- Harborview's Adult Medicine Clinic
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 |
|---|---|---|
| Cognitive-behavioral therapyParticipants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist. | Behavioural | CALM Intervention |
| Psychotropic medication optimizationAlso: SSRI, SNRI, Benzodiazepine,For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP. | Drug | CALM Intervention |
| Treatment as UsualParticipants in the control group will receive standard treatment from their PCP. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
BSI-12 (Anxiety and Somatization Subscales)
Time frame: Measured at Month 18
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
1 secondary outcome
Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9
Time frame: Measured at Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22460001Lang AJ, Wilkins K, Roy-Byrne PP, Golinelli D, Chavira D, Sherbourne C, Rose RD, Bystritsky A, Sullivan G, Craske MG, Stein MB. Abbreviated PTSD Checklist (PCL) as a guide to clinical response. Gen Hosp Psychiatry. 2012 Jul-Aug;34(4):332-8. doi: 10.1016/j.genhosppsych.2012.02.003. Epub 2012 Mar 27.
- Background: PubMed 19632667Craske MG, Roy-Byrne PP, Stein MB, Sullivan G, Sherbourne C, Bystritsky A. Treatment for anxiety disorders: Efficacy to effectiveness to implementation. Behav Res Ther. 2009 Nov;47(11):931-7. doi: 10.1016/j.brat.2009.07.012. Epub 2009 Jul 14.
- Background: PubMed 19264941Roy-Byrne P, Veitengruber JP, Bystritsky A, Edlund MJ, Sullivan G, Craske MG, Welch SS, Rose R, Stein MB. Brief intervention for anxiety in primary care patients. J Am Board Fam Med. 2009 Mar-Apr;22(2):175-86. doi: 10.3122/jabfm.2009.02.080078.
- Background: PubMed 18486238Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.
- Background: PubMed 17888803Sullivan G, Craske MG, Sherbourne C, Edlund MJ, Rose RD, Golinelli D, Chavira DA, Bystritsky A, Stein MB, Roy-Byrne PP. Design of the Coordinated Anxiety Learning and Management (CALM) study: innovations in collaborative care for anxiety disorders. Gen Hosp Psychiatry. 2007 Sep-Oct;29(5):379-87. doi: 10.1016/j.genhosppsych.2007.04.005.
- Results publication: PubMed 25272965Brown LA, Krull JL, Roy-Byrne P, Sherbourne CD, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. An examination of the bidirectional relationship between functioning and symptom levels in patients with anxiety disorders in the CALM study. Psychol Med. 2015 Feb;45(3):647-61. doi: 10.1017/S0033291714002062. Epub 2014 Oct 2.
- Results publication: PubMed 24619599Brown LA, Wiley JF, Wolitzky-Taylor K, Roy-Byrne P, Sherbourne C, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. Changes in self-efficacy and outcome expectancy as predictors of anxiety outcomes from the CALM study. Depress Anxiety. 2014 Aug;31(8):678-89. doi: 10.1002/da.22256. Epub 2014 Mar 11.
- Results publication: PubMed 24660674Chavira DA, Golinelli D, Sherbourne C, Stein MB, Sullivan G, Bystritsky A, Rose RD, Lang AJ, Campbell-Sills L, Welch S, Bumgardner K, Glenn D, Barrios V, Roy-Byrne P, Craske M. Treatment engagement and response to CBT among Latinos with anxiety disorders in primary care. J Consult Clin Psychol. 2014 Jun;82(3):392-403. doi: 10.1037/a0036365. Epub 2014 Mar 24.
- Results publication: PubMed 24338947Dour HJ, Wiley JF, Roy-Byrne P, Stein MB, Sullivan G, Sherbourne CD, Bystritsky A, Rose RD, Craske MG. Perceived social support mediates anxiety and depressive symptom changes following primary care intervention. Depress Anxiety. 2014 May;31(5):436-42. doi: 10.1002/da.22216. Epub 2013 Dec 12.
- Results publication: PubMed 23801589Joesch JM, Golinelli D, Sherbourne CD, Sullivan G, Stein MB, Craske MG, Roy-Byrne PP. Trajectories of change in anxiety severity and impairment during and after treatment with evidence-based treatment for multiple anxiety disorders in primary care. Depress Anxiety. 2013 Nov;30(11):1099-106. doi: 10.1002/da.22149. Epub 2013 Jun 25.
- Results publication: PubMed 23886736Campbell-Sills L, Stein MB, Sherbourne CD, Craske MG, Sullivan G, Golinelli D, Lang AJ, Chavira DA, Bystritsky A, Rose RD, Welch SS, Kallenberg GA, Roy-Byrne P. Effects of medical comorbidity on anxiety treatment outcomes in primary care. Psychosom Med. 2013 Oct;75(8):713-20. doi: 10.1097/PSY.0b013e31829def54. Epub 2013 Jul 25.
- Results publication: PubMed 23370069Roy-Byrne P, Sullivan MD, Sherbourne CD, Golinelli D, Craske MG, Sullivan G, Stein MB. Effects of pain and prescription opioid use on outcomes in a collaborative care intervention for anxiety. Clin J Pain. 2013 Sep;29(9):800-6. doi: 10.1097/AJP.0b013e318278d475.
- Individual participant dataSharing planned: Yes. Limited access datasets are available through the National Database for Clinical Trials Related to Mental Illness (NDCT), part of the NIMH Data Archive: https://data-archive.nimh.nih.gov/ndct/.
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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.
Peter P. Roy-Byrne, MD principal investigator
University of Washington
Cathy D. Sherbourne, PhD principal investigator
RAND Corporation, Santa Monica, CA
Michelle G. Craske, PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive-behavioral therapy, Psychotropic medication optimization and Treatment as Usual in people with Post-traumatic Stress Disorder and Generalized Anxiety Disorder, run by University of Washington at 4 sites 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 2 inclusion and 26 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BSI-12 (Anxiety and Somatization Subscales) (time frame: Measured at Month 18). 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 NCT00347269, which also lists 35 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 19 May 2017.