Clinical trial NCT05380115: Cognitive Behavioral Therapy (CBT) for Late Life Anxiety
Official title: Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: late-life anxiety
aging
cognitive-behavioral therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Week 11
measure: Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
timeFrame: week 11
measure: Feasibility-Expectancy Rating Scale
timeFrame: Week 1
measure: Feasibility-Intervention adherence
timeFrame: Week 11
measure: Feasibility-Number of participants who complete at least 75% of sessions
timeFrame: Week 11
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: baseline, week 6, week 11
measure: Insomnia Sleep Index
timeFrame: baseline, week 6, week 11
measure: Feasibility-Client Satisfaction Questionnaire
timeFrame: Week 11
measure: Feasibility-Working Alliance Inventory, Client
timeFrame: Week 11
measure: Feasibility-Working Alliance Inventory, Therapist
timeFrame: Week 11
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Baseline
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Week 6
measure: Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
timeFrame: baseline
measure: Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
timeFrame: week 6
Other outcomes:
measure: Healthcare Utilization-Number of Outpatient encounters
timeFrame: Week 37
measure: Healthcare Utilization-Number of ED visits
timeFrame: Week 37
measure: Healthcare Utilization-Number of inpatient stays
timeFrame: Week 37
measure: Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays
timeFrame: Week 37
measure: Qualitative Interviews
timeFrame: Week 11
Locations:
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Gretchen Brenes, PhD
role: PRINCIPAL_INVESTIGATOR
References: