AnxietyNCT02391363
Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
A study testing Cognitive behavior treatment and Information and referral in people with Anxiety, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Cognitive behavior treatment and Information and referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Feb 2018
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSWQ greater than 22
Who cannot join
- PHQ score less than 20
- Active suicidal intent
- Active psychosis or bipolar disorder
- Substance abuse
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)
Houston, Texas, 77030
About this study
The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.
Read the detailed description
Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.
Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?
Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.
- Conditions
- Anxiety
- Being tested
- Cognitive behavior treatment, Information and referral
- Keywords
- anxiety, worry
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior treatmentBehavioural
Anxiety management skills with the option to included religious/spiritual beliefs and practices
Information and referralBehavioural
Resource counseling and follow-up for mental health and basic needs
| Study group | Role | What they receive |
|---|---|---|
| Calmer Life | Experimental | Cognitive behavior treatment for anxiety Receives: Behavioral: Cognitive behavior treatment |
| Enhanced Community Care | Active comparator | Enhanced information and referral services for mental health and basic needs Receives: Behavioral: Information and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Measured: Baseline, 6 months
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Measured: Baseline, 9 months
Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Measured: Baseline, 6 months
Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Measured: Baseline, 9 months
Secondary outcomes (26)
Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Measured: Baseline, 6 months
Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Measured: Baseline, 9 months
Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Measured: Baseline, 6 months
Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Measured: Baseline, 9 months
Geriatric Depression Scale Short Form (GDS) at 6 Months
Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Measured: Baseline, 6 months
Geriatric Depression Scale Short Form (GDS) at 9 Months
Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Measured: Baseline, 9 months
Insomnia Severity Index (ISI) at 6 Months
Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Measured: Baseline, 6 months
Insomnia Severity Index (ISI) at 9 Months
Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Measured: Baseline, 9 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Measured: Baseline, 6 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months
Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Measured: Baseline, 9 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Measured: Baseline, 6 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Measured: Baseline, 9 months
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months
Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Measured: Baseline, 6 months
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)
Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Measured: Baseline, 9 months
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months
Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Measured: Baseline, 6 months
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months
Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Measured: Baseline, 9 months
PTSD Checklist-5 (PCL-5) Total at 6 Months
Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Measured: Baseline, 6 months
PTSD Checklist-5 (PCL-5) Total at 9 Months
Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Measured: Baseline, 9 months
Health Service Use at 6 Months
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Measured: Baseline, 6 months
Health Service Use at 9 Months
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Measured: Baseline, 9 months
Hospital Admissions at 6 Months
Number of participants who were admitted to a hospital in the past 3 months.
Measured: Baseline, 6 months
Hospital Admissions at 9 Months
Number of participants who were admitted to a hospital in the past 3 months.
Measured: Baseline, 9 months
Social Service or Resource Use at 6 Months
Number of participants who received social services or resources over the past 3 months
Measured: Baseline, 6 months
Social Service or Resource Use at 9 Months
Number of participants who received social services or resources over the past 3 months
Measured: Baseline, 9 months
Psychological Service Use at 6 Months
Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Measured: Baseline, 6 months
Psychological Service Use at 9 Months
Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Measured: Baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2017
- Study completionFeb 2018
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 (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Melinda Stanley, Baylor College of Medicine
- Investigators
- Melinda A Stanley, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391363
- Sponsor's protocol ID
- AD-1310-06824
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2015
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stanley MA, Wilson NL, Shrestha S, Amspoker AB, Wagener P, Bavineau J, Turner M, Fletcher TL, Freshour J, Kraus-Schuman C, Kunik ME. Community-Based Outreach and Treatment for Underserved Older Adults With Clinically Significant Worry: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2018 Nov;26(11):1147-1162. doi: 10.1016/j.jagp.2018.07.011. Epub 2018 Aug 7.
PubMed 30224269Steiner AJ, Boulos N, Wright SM, Mirocha J, Smith K, Lopez E, Gohar SH, Ishak WW. Major Depressive Disorder in Patients With Doctoral Degrees: Patient-reported Depressive Symptom Severity, Functioning, and Quality of Life Before and After Initial Treatment in the STAR*D Study. J Psychiatr Pract. 2017 Sep;23(5):328-341. doi: 10.1097/PRA.0000000000000251.
PubMed 28961662Shrestha S, Wilson N, Kunik ME, Wagener P, Amspoker AB, Barrera T, Freshour J, Kraus-Schuman C, Bavineau J, Turner M, Stanley MA. Calmer Life: A Hybrid Effectiveness-implementation Trial for Late-life Anxiety Conducted in Low-income, Mental Health-Underserved Communities. J Psychiatr Pract. 2017 May;23(3):180-190. doi: 10.1097/PRA.0000000000000234.
PubMed 28492456
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
- ClinicalTrials.gov ID
- NCT02391363
- Acronym / sponsor ID
- AD-1310-06824
- Conditions
- Anxiety
- Keywords
- anxiety, worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Nov 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.
Detailed description
Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.
Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?
Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calmer Life | Experimental | Behavioral: Cognitive behavior treatmentCognitive behavior treatment for anxiety |
| Enhanced Community Care | Active comparator | Behavioral: Information and referralEnhanced information and referral services for mental health and basic needs |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PSWQ greater than 22
Key exclusion criteria (5 listed)
- PHQ score less than 20
- Active suicidal intent
- Active psychosis or bipolar disorder
- Substance abuse
- Cognitive impairment
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 behavior treatmentAnxiety management skills with the option to included religious/spiritual beliefs and practices | Behavioural | Calmer Life |
| Information and referralResource counseling and follow-up for mental health and basic needs | Behavioural | Enhanced Community Care |
Primary outcome
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
Time frame: Baseline, 6 months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
Time frame: Baseline, 9 months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
Time frame: Baseline, 6 months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
Time frame: Baseline, 9 months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
26 secondary outcomes
Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
Time frame: Baseline, 6 months
Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
Time frame: Baseline, 9 months
Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
Time frame: Baseline, 6 months
Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
Time frame: Baseline, 9 months
Geriatric Depression Scale Short Form (GDS) at 6 Months
Time frame: Baseline, 6 months
Geriatric Depression Scale Short Form (GDS) at 9 Months
Time frame: Baseline, 9 months
Insomnia Severity Index (ISI) at 6 Months
Time frame: Baseline, 6 months
Insomnia Severity Index (ISI) at 9 Months
Time frame: Baseline, 9 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
Time frame: Baseline, 6 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months
Time frame: Baseline, 9 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
Time frame: Baseline, 6 months
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
Time frame: Baseline, 9 months
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months
Time frame: Baseline, 6 months
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)
Time frame: Baseline, 9 months
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months
Time frame: Baseline, 6 months
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months
Time frame: Baseline, 9 months
PTSD Checklist-5 (PCL-5) Total at 6 Months
Time frame: Baseline, 6 months
PTSD Checklist-5 (PCL-5) Total at 9 Months
Time frame: Baseline, 9 months
Health Service Use at 6 Months
Time frame: Baseline, 6 months
Health Service Use at 9 Months
Time frame: Baseline, 9 months
Hospital Admissions at 6 Months
Time frame: Baseline, 6 months
Hospital Admissions at 9 Months
Time frame: Baseline, 9 months
Social Service or Resource Use at 6 Months
Time frame: Baseline, 6 months
Social Service or Resource Use at 9 Months
Time frame: Baseline, 9 months
Psychological Service Use at 6 Months
Time frame: Baseline, 6 months
Psychological Service Use at 9 Months
Time frame: Baseline, 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30224269Stanley MA, Wilson NL, Shrestha S, Amspoker AB, Wagener P, Bavineau J, Turner M, Fletcher TL, Freshour J, Kraus-Schuman C, Kunik ME. Community-Based Outreach and Treatment for Underserved Older Adults With Clinically Significant Worry: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2018 Nov;26(11):1147-1162. doi: 10.1016/j.jagp.2018.07.011. Epub 2018 Aug 7.
- Derived from this study: PubMed 28961662Steiner AJ, Boulos N, Wright SM, Mirocha J, Smith K, Lopez E, Gohar SH, Ishak WW. Major Depressive Disorder in Patients With Doctoral Degrees: Patient-reported Depressive Symptom Severity, Functioning, and Quality of Life Before and After Initial Treatment in the STAR*D Study. J Psychiatr Pract. 2017 Sep;23(5):328-341. doi: 10.1097/PRA.0000000000000251.
- Derived from this study: PubMed 28492456Shrestha S, Wilson N, Kunik ME, Wagener P, Amspoker AB, Barrera T, Freshour J, Kraus-Schuman C, Bavineau J, Turner M, Stanley MA. Calmer Life: A Hybrid Effectiveness-implementation Trial for Late-life Anxiety Conducted in Low-income, Mental Health-Underserved Communities. J Psychiatr Pract. 2017 May;23(3):180-190. doi: 10.1097/PRA.0000000000000234.
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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.
Melinda A Stanley, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior treatment and Information and referral in people with Anxiety, run by Baylor College of Medicine 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 1 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 31 May 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). 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?
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months (time frame: Baseline, 6 months). The study lists 4 primary outcomes in all. 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 NCT02391363, which also lists 3 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 31 May 2019.