An interventional study of Cognitive Behavioral Therapy (CBT) in Generalized Anxiety Disorder, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
Browse Anxiety Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects enrolled received CBT for 10 weeks.
Behavioral: Cognitive Behavioral Therapy (CBT)
weekly one on one video or telephone interviews with a study coach
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 6
Healthcare Utilization-Number of Outpatient encounters
Time frame: Week 37
Healthcare Utilization-Number of ED visits
Time frame: Week 37
Healthcare Utilization-Number of inpatient stays
Time frame: Week 37
Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays
Time frame: Week 37
Qualitative Interviews
Analyses will be primarily conducted by Q-PRO
Time frame: Week 11
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences