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Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Primary Purpose

Generalized Anxiety Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Generalized Anxiety Disorder focused on measuring late-life anxiety, aging, cognitive-behavioral therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants who have had an outpatient visit to an Atrium provider
  • at least one of the following: any diagnosis of an anxiety or depressive disorder; anxiety, depression, or sleep disturbance as a symptom in the problem list or in the note; and use of anxiolytic, anti-depressant, and sleep aide medications.

Exclusion Criteria:

  • diagnosis of dementia or cognitive impairment in the problem list

Sites / Locations

  • Atrium Health Wake Forest Baptist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT

Arm Description

All subjects enrolled received CBT for 10 weeks.

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder scale (GAD-7)
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.
Feasibility-Expectancy Rating Scale
Assesses beliefs in how logical the treatment received seems, confidence in undergoing treatment/recommending to others, and expectations for success. Used in anxiety treatment studies with older adults. Scores can range from 4 to 40; higher scores indicate more positive expectations.
Feasibility-Intervention adherence
The percentage of completed sessions
Feasibility-Number of participants who complete at least 75% of sessions

Secondary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS)
8-item measure of general anxiety symptoms; each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always); scores can range from 8 to 40; higher scores indicate greater severity of anxiety.
Insomnia Sleep Index
7-item self-report measure of type and severity of insomnia symptoms. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem); scores can range from 0 to 28 with higher scores indicating more severe insomnia.
Feasibility-Client Satisfaction Questionnaire
Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Feasibility-Working Alliance Inventory, Client
Assesses therapist-client working alliance. 12 items on a 7-point scale (1=never; 7=always); scores can range from 12 to 84 with higher scores indicating better working relationship.
Feasibility-Working Alliance Inventory, Therapist
Assesses therapist-client working alliance. 12 items on a 7-point scale (1=never; 7=always); scores can range from 12 to 84 with higher scores indicating better working relationship.
Generalized Anxiety Disorder scale (GAD-7)
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Generalized Anxiety Disorder scale (GAD-7)
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.

Full Information

First Posted
May 12, 2022
Last Updated
July 31, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05380115
Brief Title
Cognitive Behavioral Therapy (CBT) for Late Life Anxiety
Official Title
Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to assess the acceptability and feasibility of the implementation strategy and fidelity of cognitive-behavioral therapy (CBT) for older adults with Generalized Anxiety Disorder.
Detailed Description
All participants will receive CBT. Each subject will be given a workbook and each chapter in the workbook provides information about a different coping strategy for managing worry and anxiety. There will be a daily assignment in the workbook to complete before a call with the personal study coach. For 10 weeks, participants will have a 45-50 minute session (telephone or video) each week with their study coach. These calls will be confidential. The participant and the personal study coach will review the assigned chapter and completed homework during the weekly telephone sessions. Participants will also fill out questionnaires before starting sessions, when completing all 10 sessions, and 6 months after completing sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
late-life anxiety, aging, cognitive-behavioral therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
All subjects enrolled received CBT for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
weekly one on one video or telephone interviews with a study coach
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder scale (GAD-7)
Description
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Time Frame
Week 11
Title
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Description
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.
Time Frame
week 11
Title
Feasibility-Expectancy Rating Scale
Description
Assesses beliefs in how logical the treatment received seems, confidence in undergoing treatment/recommending to others, and expectations for success. Used in anxiety treatment studies with older adults. Scores can range from 4 to 40; higher scores indicate more positive expectations.
Time Frame
Week 1
Title
Feasibility-Intervention adherence
Description
The percentage of completed sessions
Time Frame
Week 11
Title
Feasibility-Number of participants who complete at least 75% of sessions
Time Frame
Week 11
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
8-item measure of general anxiety symptoms; each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always); scores can range from 8 to 40; higher scores indicate greater severity of anxiety.
Time Frame
baseline, week 6, week 11
Title
Insomnia Sleep Index
Description
7-item self-report measure of type and severity of insomnia symptoms. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem); scores can range from 0 to 28 with higher scores indicating more severe insomnia.
Time Frame
baseline, week 6, week 11
Title
Feasibility-Client Satisfaction Questionnaire
Description
Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Time Frame
Week 11
Title
Feasibility-Working Alliance Inventory, Client
Description
Assesses therapist-client working alliance. 12 items on a 7-point scale (1=never; 7=always); scores can range from 12 to 84 with higher scores indicating better working relationship.
Time Frame
Week 11
Title
Feasibility-Working Alliance Inventory, Therapist
Description
Assesses therapist-client working alliance. 12 items on a 7-point scale (1=never; 7=always); scores can range from 12 to 84 with higher scores indicating better working relationship.
Time Frame
Week 11
Title
Generalized Anxiety Disorder scale (GAD-7)
Description
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Time Frame
Baseline
Title
Generalized Anxiety Disorder scale (GAD-7)
Description
Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.
Time Frame
Week 6
Title
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Description
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.
Time Frame
baseline
Title
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Description
8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.
Time Frame
week 6
Other Pre-specified Outcome Measures:
Title
Healthcare Utilization-Number of Outpatient encounters
Time Frame
Week 37
Title
Healthcare Utilization-Number of ED visits
Time Frame
Week 37
Title
Healthcare Utilization-Number of inpatient stays
Time Frame
Week 37
Title
Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays
Time Frame
Week 37
Title
Qualitative Interviews
Description
Analyses will be primarily conducted by Q-PRO
Time Frame
Week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants who have had an outpatient visit to an Atrium provider at least one of the following: any diagnosis of an anxiety or depressive disorder; anxiety, depression, or sleep disturbance as a symptom in the problem list or in the note; and use of anxiolytic, anti-depressant, and sleep aide medications. Exclusion Criteria: diagnosis of dementia or cognitive impairment in the problem list
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gretchen Brenes, PhD
Phone
336-716-1103
Email
gbrenes@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD
Organizational Affiliation
Atrium Health Wake Forest Baptist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD
Phone
336-716-1103
Email
gbrenes@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

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