Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05380115
• Other study ID #: IRB00084483
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2023
• Source: Wake Forest University Health Sciences
• Contact: Gretchen Brenes, PhD
• Phone: 336-716-1103
• Email: gbrenes[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
weekly one on one video or telephone interviews with a study coach

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare Utilization-Number of Outpatient encounters		Week 37
Other	Healthcare Utilization-Number of ED visits		Week 37
Other	Healthcare Utilization-Number of inpatient stays		Week 37
Other	Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays		Week 37
Other	Qualitative Interviews	Analyses will be primarily conducted by Q-PRO	Week 11
Primary	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
Primary	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
Primary	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
Primary	Feasibility-Intervention adherence	The percentage of completed sessions	Week 11
Primary	Feasibility-Number of participants who complete at least 75% of sessions		Week 11
Secondary	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
Secondary	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
Secondary	Feasibility-Client Satisfaction Questionnaire	Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction.	Week 11
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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