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Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities

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ClinicalTrials.gov Identifier: NCT02391363
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Cognitive behavior treatment Behavioral: Information and referral Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
Study Start Date : November 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Calmer Life
Cognitive behavior treatment for anxiety
Behavioral: Cognitive behavior treatment
Anxiety management skills with the option to included religious/spiritual beliefs and practices

Active Comparator: Enhanced Community Care
Enhanced information and referral services for mental health and basic needs
Behavioral: Information and referral
Resource counseling and follow-up for mental health and basic needs




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months [ Time Frame: Baseline, 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.

  2. Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months [ Time Frame: Baseline, 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.

  3. Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months [ Time Frame: Baseline, 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.

  4. Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months [ Time Frame: Baseline, 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.

  5. Geriatric Depression Scale Short Form (GDS) at 6 Months [ Time Frame: Baseline, 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.

  6. Geriatric Depression Scale Short Form (GDS) at 9 Months [ Time Frame: Baseline, 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.

  7. Insomnia Severity Index (ISI) at 6 Months [ Time Frame: Baseline, 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.

  8. Insomnia Severity Index (ISI) at 9 Months [ Time Frame: Baseline, 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.

  9. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months [ Time Frame: Baseline, 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.

  10. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months [ Time Frame: Baseline, 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.

  11. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months [ Time Frame: Baseline, 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.

  12. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation [ Time Frame: Baseline, 9 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.

  13. Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months [ Time Frame: Baseline, 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.

  14. Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) [ Time Frame: Baseline, 9 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.

  15. Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months [ Time Frame: Baseline, 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.

  16. Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months [ Time Frame: Baseline, 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.

  17. PTSD Checklist-5 (PCL-5) Total at 6 Months [ Time Frame: Baseline, 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.

  18. PTSD Checklist-5 (PCL-5) Total at 9 Months [ Time Frame: Baseline, 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.

  19. Health Service Use at 6 Months [ Time Frame: Baseline, 6 months ]
    Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.

  20. Health Service Use at 9 Months [ Time Frame: Baseline, 9 months ]
    Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.

  21. Hospital Admissions at 6 Months [ Time Frame: Baseline, 6 months ]
    Number of participants who were admitted to a hospital in the past 3 months.

  22. Hospital Admissions at 9 Months [ Time Frame: Baseline, 9 months ]
    Number of participants who were admitted to a hospital in the past 3 months.

  23. Social Service or Resource Use at 6 Months [ Time Frame: Baseline, 6 months ]
    Number of participants who received social services or resources over the past 3 months

  24. Social Service or Resource Use at 9 Months [ Time Frame: Baseline, 9 months ]
    Number of participants who received social services or resources over the past 3 months

  25. Psychological Service Use at 6 Months [ Time Frame: Baseline, 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

  26. Psychological Service Use at 9 Months [ Time Frame: Baseline, 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PSWQ greater than 22

Exclusion Criteria:

  • PHQ score less than 20
  • Active suicidal intent
  • Active psychosis or bipolar disorder
  • Substance abuse
  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391363


Locations
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United States, Texas
VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Melinda A Stanley, PhD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Melinda Stanley, Baylor College of Medicine:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melinda Stanley, Professor and Head, Division of Psychology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02391363     History of Changes
Other Study ID Numbers: AD-1310-06824
First Posted: March 18, 2015    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: February 2019
Keywords provided by Melinda Stanley, Baylor College of Medicine:
anxiety
worry