AnxietyNCT00932178
Calmer Life: A Worry Reduction Program for Older Adults
A study testing Calmer Life in people with Anxiety, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Calmer Life is a research study for older adults with anxiety. In the program participants will have the opportunity to learn skills that may help cope with anxiety. Participants have the option of including religion and spirituality into the skill. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Calmer Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2016
- 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+;
- A principal or co-principal diagnosis of General Anxiety Disorder;
- Interest in receiving CBT for anxiety/depression with the option of including religion and spirituality;
- Must be English speaking
Who cannot join
- Active suicidal intent;
- Current psychosis or bipolar disorder;
- Substance abuse within the last month
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Calmer Life is a research study for older adults with anxiety. In the program participants will have the opportunity to learn skills that may help cope with anxiety. Participants have the option of including religion and spirituality into the skill. Skills participants can learn include: how to relax, how to change the way you think about things, and how to solve problems more effectively.
Read the detailed description
Preliminary work in a related study (H-22763) suggests that a significant percentage of older patients think that incorporating religion and/or spirituality into counseling is important. Based on data from this study, available scholarly literature, and input from consultants, we have developed an initial version of Calmer Life that is sufficiently flexible to incorporate a range of religious and spiritual beliefs and coping skills based on each patient's unique values and beliefs. The manual for this treatment includes intervention components from evidence-based treatment for late-life anxiety (H-23798; H-15958), suggested strategies for incorporating religion or spirituality into the coping skills for anxiety and depression, and spiritually-based interventions (e.g., forgiveness, gratitude). Patients have a choice to include or not include religious or spiritually based components. The proposed project will begin to test this broad spiritually based CBT for older adults (Calmer Life) with Generalized Anxiety Disorder (GAD) with or without depression. Further modifications to the Calmer Life manual and in the treatment approach will be made based on patient, clinician, and consultant input.
- Conditions
- Anxiety
- Being tested
- Calmer Life
- Keywords
- Anxiety, Worry, nervousness, Older Adult
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calmer LifeBehavioural
Calmer Life is a modified version of an existing Cognitive Behavioral Treatment manual. Participants have the option of including religion and spirituality into coping skills taught as a way of treating anxiety with or without depression in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Calmer Life | Experimental | Skills-based intervention to reduce anxiety and worry in adults age 50+. Receives: Behavioral: Calmer Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI)
Measured: Baseline, 1-month, 2-month, 3-month, and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2016
- Study completionFeb 2016
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Stanley, Baylor College of Medicine
- Investigators
- Melinda A. Stanley, PhD, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932178
- Sponsor's protocol ID
- MIRECC006
- Other IDs
- VA ID Number: 09E02.H
- Status last verified
- Jan 2018
- First submitted
- 1 Jul 2009
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jameson JP, Shrestha S, Escamilla M, Clark S, Wilson N, Kunik M, Zeno D, Harris TB, Peters A, Varner IL, Scantlebury C, Scott-Gurnell K, Stanley M. Establishing community partnerships to support late-life anxiety research: lessons learned from the Calmer Life project. Aging Ment Health. 2012;16(7):874-83. doi: 10.1080/13607863.2012.660621. Epub 2012 Mar 15.
PubMed 22416908
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calmer Life: A Worry Reduction Program for Older Adults
- ClinicalTrials.gov ID
- NCT00932178
- Acronym / sponsor ID
- MIRECC006
- Conditions
- Anxiety
- Keywords
- Anxiety, Worry, nervousness, Older Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Jul 2009 (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.
Calmer Life is a research study for older adults with anxiety. In the program participants will have the opportunity to learn skills that may help cope with anxiety. Participants have the option of including religion and spirituality into the skill. Skills participants can learn include: how to relax, how to change the way you think about things, and how to solve problems more effectively.
Detailed description
Preliminary work in a related study (H-22763) suggests that a significant percentage of older patients think that incorporating religion and/or spirituality into counseling is important. Based on data from this study, available scholarly literature, and input from consultants, we have developed an initial version of Calmer Life that is sufficiently flexible to incorporate a range of religious and spiritual beliefs and coping skills based on each patient's unique values and beliefs. The manual for this treatment includes intervention components from evidence-based treatment for late-life anxiety (H-23798; H-15958), suggested strategies for incorporating religion or spirituality into the coping skills for anxiety and depression, and spiritually-based interventions (e.g., forgiveness, gratitude). Patients have a choice to include or not include religious or spiritually based components. The proposed project will begin to test this broad spiritually based CBT for older adults (Calmer Life) with Generalized Anxiety Disorder (GAD) with or without depression. Further modifications to the Calmer Life manual and in the treatment approach will be made based on patient, clinician, and consultant input.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calmer Life | Experimental | Behavioral: Calmer LifeSkills-based intervention to reduce anxiety and worry in adults age 50+. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50+;
- A principal or co-principal diagnosis of General Anxiety Disorder;
- Interest in receiving CBT for anxiety/depression with the option of including religion and spirituality;
- Must be English speaking
Key exclusion criteria (3 listed)
- Active suicidal intent;
- Current psychosis or bipolar disorder;
- Substance abuse within the last month
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 |
|---|---|---|
| Calmer LifeCalmer Life is a modified version of an existing Cognitive Behavioral Treatment manual. Participants have the option of including religion and spirituality into coping skills taught as a way of treating anxiety with or without depression in older adults. | Behavioural | Calmer Life |
Primary outcome
Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 1-month, 2-month, 3-month, and 6-month
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 23 Jan 2018.
- Background: PubMed 22416908Jameson JP, Shrestha S, Escamilla M, Clark S, Wilson N, Kunik M, Zeno D, Harris TB, Peters A, Varner IL, Scantlebury C, Scott-Gurnell K, Stanley M. Establishing community partnerships to support late-life anxiety research: lessons learned from the Calmer Life project. Aging Ment Health. 2012;16(7):874-83. doi: 10.1080/13607863.2012.660621. Epub 2012 Mar 15.
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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
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calmer Life 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 4 inclusion and 3 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 23 Jan 2018. 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 Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI) (time frame: Baseline, 1-month, 2-month, 3-month, and 6-month). 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 NCT00932178, 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 23 Jan 2018.