Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder

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.

Study Overview

• Status: Withdrawn
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; All subjects enrolled received CBT for 10 weeks.	Behavioral: Cognitive Behavioral Therapy (CBT); weekly one on one video or telephone interviews with a study coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 11
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.	week 11
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.	Week 1
Feasibility-Intervention adherence	The percentage of completed sessions	Week 11
Feasibility-Number of participants who complete at least 75% of sessions		Week 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 6, week 11
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.	baseline, week 6, week 11
Feasibility-Client Satisfaction Questionnaire	Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction.	Week 11
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.	Week 11
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.	Week 11
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.	Baseline
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.	Week 6
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.	baseline
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.	week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization-Number of Outpatient encounters		Week 37
Healthcare Utilization-Number of ED visits		Week 37
Healthcare Utilization-Number of inpatient stays		Week 37
Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays		Week 37
Qualitative Interviews	Analyses will be primarily conducted by Q-PRO	Week 11

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Gretchen Brenes, PhD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: aging; cognitive-behavioral therapy; late-life anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB00084483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No