Generalized Anxiety DisorderNCT01702220
Calmer Life: Testing the Effectiveness of a Treatment for Anxiety
A study testing CBT and ECC in people with Generalized Anxiety Disorder and Anxiety Disorder NOS, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, Anxiety Disorder NOS
- What is being tested?
- CBT and ECC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2015
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 and older
- Principal or Co-principal diagnosis of GAD or ADNOS
- Must speak English
- Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider
- Must live, work, worship, attend community functions, and/or receive health care in target geographic areas
Who cannot join
- Active suicidal intent
- Current psychosis
- Mania or substance abuse within the last month
- Cognitive impairment according to a Mini Cog screener score of 3 or lower
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, 77030
About this study
Official title: Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.
Read the detailed description
Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format.
Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months.
Participants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.
Participants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention.
Outcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.
- Conditions
- Generalized Anxiety Disorder, Anxiety Disorder NOS
- Being tested
- CBT, ECC
- Keywords
- Generalized Anxiety Disorder, Geriatric
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called Cognitive Behavior Treatment, Cognitive Behavior Therapy
6-12 sessions of CBT in person or over the phone
ECCOther
Also called Enhanced Community Care
6 biweekly sessions of ECC over the telephone
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Behavioral: CBT |
| Enhanced Community Care (ECC) | Active comparator | Not described Receives: Other: ECC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Anxiety Inventory
Measured: 3 months
Penn State Worry Questionnaire (PSWQ-A)
Measured: 3 months
Generalized Anxiety Disorder-7
Measured: 3 months
Secondary outcomes (11)
Patient Health Questionnaire-9
Measured: 3 months
Insomnia Severity Index
Measured: 3 months
Late-Life Functional Disability Index
Measured: 3 months
SF-12 Health Survey
Measured: 3 months
Client Satisfaction Questionnaire
Measured: 3 months
Brief RCOPE
Religious coping
Measured: 3 months
Health services use
Measured: 3 months
Use of psychotropic medication
Measured: 3 months
Brief Multidimensional Measure of Religiousness and Spirituality
Measured: 3 months
Satisfaction with Life Scale
Measured: 3 months
Geriatric Depression Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation, Archstone Foundation
- 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
- NCT01702220
- Sponsor's protocol ID
- H30928
- Status last verified
- Jan 2016
- First submitted
- 4 Oct 2012
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stanley MA, Wilson N, Shrestha S, Amspoker AB, Armento M, Cummings JP, Evans-Hudnall G, Wagener P, Kunik ME. Calmer Life: A Culturally Tailored Intervention for Anxiety in Underserved Older Adults. Am J Geriatr Psychiatry. 2016 Aug;24(8):648-658. doi: 10.1016/j.jagp.2016.03.008. Epub 2016 Mar 29.
PubMed 27426212
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults
- ClinicalTrials.gov ID
- NCT01702220
- Acronym / sponsor ID
- H30928
- Conditions
- Generalized Anxiety Disorder, Anxiety Disorder NOS
- Keywords
- Generalized Anxiety Disorder, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Retirement Research Foundation, Archstone Foundation
- Study start
- Oct 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Oct 2012 (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.
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.
Detailed description
Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format.
Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months.
Participants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.
Participants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention.
Outcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: CBT |
| Enhanced Community Care (ECC) | Active comparator | Other: ECC |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 and older
- Principal or Co-principal diagnosis of GAD or ADNOS
- Must speak English
- Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider
- Must live, work, worship, attend community functions, and/or receive health care in target geographic areas
Key exclusion criteria (4 listed)
- Active suicidal intent
- Current psychosis
- Mania or substance abuse within the last month
- Cognitive impairment according to a Mini Cog screener score of 3 or lower
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 |
|---|---|---|
| CBTAlso: Cognitive Behavior Treatment, Cognitive Behavior Therapy6-12 sessions of CBT in person or over the phone | Behavioural | CBT |
| ECCAlso: Enhanced Community Care6 biweekly sessions of ECC over the telephone | Other | Enhanced Community Care (ECC) |
Primary outcome
Geriatric Anxiety Inventory
Time frame: 3 months
Penn State Worry Questionnaire (PSWQ-A)
Time frame: 3 months
Generalized Anxiety Disorder-7
Time frame: 3 months
11 secondary outcomes
Patient Health Questionnaire-9
Time frame: 3 months
Insomnia Severity Index
Time frame: 3 months
Late-Life Functional Disability Index
Time frame: 3 months
SF-12 Health Survey
Time frame: 3 months
Client Satisfaction Questionnaire
Time frame: 3 months
Brief RCOPE
Time frame: 3 months
Health services use
Time frame: 3 months
Use of psychotropic medication
Time frame: 3 months
Brief Multidimensional Measure of Religiousness and Spirituality
Time frame: 3 months
Satisfaction with Life Scale
Time frame: 3 months
Geriatric Depression Scale
Time frame: 3 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 12 Jan 2016.
- Derived from this study: PubMed 27426212Stanley MA, Wilson N, Shrestha S, Amspoker AB, Armento M, Cummings JP, Evans-Hudnall G, Wagener P, Kunik ME. Calmer Life: A Culturally Tailored Intervention for Anxiety in Underserved Older Adults. Am J Geriatr Psychiatry. 2016 Aug;24(8):648-658. doi: 10.1016/j.jagp.2016.03.008. Epub 2016 Mar 29.
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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 CBT and ECC in people with Generalized Anxiety Disorder and Anxiety Disorder NOS, 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 5 inclusion and 4 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 12 Jan 2016. 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?
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?
Geriatric Anxiety Inventory (time frame: 3 months). The study lists 3 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 NCT01702220, which also lists 1 linked publication.
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 12 Jan 2016.