Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Overview

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.

Full Title of Study: “Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: CBT
    • All subjects enrolled received CBT for 10 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Generalized Anxiety Disorder scale (GAD-7)
    • Time Frame: Week 11
    • 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)
    • Time Frame: week 11
    • 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
    • Time Frame: Week 1
    • 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
    • Time Frame: Week 11
    • The percentage of completed sessions
  • Feasibility-Number of participants who complete at least 75% of sessions
    • Time Frame: Week 11

Secondary Measures

  • Patient-Reported Outcomes Measurement Information System (PROMIS)
    • Time Frame: baseline, week 6, week 11
    • 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
    • Time Frame: baseline, week 6, week 11
    • 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
    • Time Frame: Week 11
    • Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction.
  • Feasibility-Working Alliance Inventory, Client
    • Time Frame: Week 11
    • 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
    • Time Frame: Week 11
    • 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)
    • Time Frame: Baseline
    • 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)
    • Time Frame: Week 6
    • 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)
    • Time Frame: baseline
    • 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)
    • Time Frame: week 6
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gretchen Brenes, PhD, Principal Investigator, Atrium Health Wake Forest Baptist
  • Overall Contact(s)
    • Gretchen Brenes, PhD, 336-716-1103, gbrenes@wakehealth.edu

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