NCT01702220

Brief 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 implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

October 4, 2012

Last Update Submit

January 11, 2016

Conditions

Generalized Anxiety DisorderAnxiety Disorder NOS

Keywords

Generalized Anxiety DisorderGeriatric

Outcome Measures

Primary Outcomes (3)

  • Geriatric Anxiety Inventory

    3 months

  • Penn State Worry Questionnaire (PSWQ-A)

    3 months

  • Generalized Anxiety Disorder-7

    3 months

Secondary Outcomes (11)

  • Patient Health Questionnaire-9

    3 months

  • Insomnia Severity Index

    3 months

  • Late-Life Functional Disability Index

    3 months

  • SF-12 Health Survey

    3 months

  • Client Satisfaction Questionnaire

    3 months

  • +6 more secondary outcomes

Study Arms (2)

CBT

EXPERIMENTAL
Behavioral: CBT

Enhanced Community Care (ECC)

ACTIVE COMPARATOR
Other: ECC

Interventions

CBTBEHAVIORAL

6-12 sessions of CBT in person or over the phone

Also known as: Cognitive Behavior Treatment, Cognitive Behavior Therapy
CBT
ECCOTHER

6 biweekly sessions of ECC over the telephone

Also known as: Enhanced Community Care
Enhanced Community Care (ECC)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 27426212DERIVED

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melinda A Stanley, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 8, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)