Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Wake Forest University Health Sciences

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

weekly one on one video or telephone interviews with a study coach

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Week 1

Feasibility-Intervention adherence

The percentage of completed sessions

Time frame: Week 11

Feasibility-Number of participants who complete at least 75% of sessions

Time frame: Week 11

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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