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

NCT02391363 | Completed Results DMC

• 1 other identifier: AD-1310-06824
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

anxiety; worry

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 9 months

Secondary Outcomes (26)

• Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months

  Baseline, 6 months

• Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months

  Baseline, 9 months

• Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months

  Baseline, 6 months

• Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months

  Baseline, 9 months

• Geriatric Depression Scale Short Form (GDS) at 6 Months

  Baseline, 6 months

Study Arms (2)

Calmer Life

EXPERIMENTAL

Cognitive behavior treatment for anxiety

Behavioral: Cognitive behavior treatment

Enhanced Community Care

ACTIVE COMPARATOR

Enhanced information and referral services for mental health and basic needs

Behavioral: Information and referral

Interventions

Cognitive behavior treatment BEHAVIORAL

Anxiety management skills with the option to included religious/spiritual beliefs and practices

Calmer Life

Information and referral BEHAVIORAL

Resource counseling and follow-up for mental health and basic needs

Enhanced Community Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSWQ greater than 22

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 30224269 DERIVED

• Steiner 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.

  PMID: 28961662 DERIVED

• Shrestha 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.

  PMID: 28492456 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Melinda A. Stanley, PhD
• Organization: Baylor College of Medicine

mstanley@bcm.edu

713-794-8841

Study Officials

• Melinda A Stanley, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Division of Psychology

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 18, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-02

Locations

US (1)