Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late-life anxiety, aging, cognitive-behavioral therapy