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The investigators were running out of time on a 1 year pilot grant and had to prioritize other parts of the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT | Experimental | All subjects enrolled received CBT for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | weekly one on one video or telephone interviews with a study coach |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Brenes, PhD | Atrium Health Wake Forest Baptist | Principal Investigator |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| 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 |