Generalized Anxiety Disorder
Conditions
Keywords
late-life anxiety, aging, cognitive-behavioral therapy
Brief 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.
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
BEHAVIORALCognitive Behavioral Therapy (CBT)
weekly one on one video or telephone interviews with a study coach
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility-Expectancy Rating Scale | 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. |
| Generalized Anxiety Disorder scale (GAD-7) | 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) | 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-Number of participants who complete at least 75% of sessions | Week 11 | — |
| Feasibility-Intervention adherence | Week 11 | The percentage of completed sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder scale (GAD-7) | Baseline | 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) | 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. |
| Feasibility-Working Alliance Inventory, Client | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | 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 | 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 | Week 11 | Assesses satisfaction with treatment. Scores can range from 8 to 32; higher scores indicate more satisfaction. |
| Feasibility-Working Alliance Inventory, Therapist | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization-Number of Outpatient encounters | Week 37 | — |
| Qualitative Interviews | Week 11 | Analyses will be primarily conducted by Q-PRO |
| Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays | Week 37 | — |
| Healthcare Utilization-Number of inpatient stays | Week 37 | — |
| Healthcare Utilization-Number of ED visits | Week 37 | — |
Outcome results
None listed