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Clinical Trials/NCT05380115
NCT05380115
Withdrawn
N/A

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

Overview

Phase
N/A
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Wake Forest University Health Sciences
Primary Endpoint
Feasibility-Number of participants who complete at least 75% of sessions
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
February 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Feasibility-Number of participants who complete at least 75% of sessions

Time Frame: Week 11

Penn State Worry Questionnaire-Abbreviated (PSWQ-A)

Time Frame: 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-Expectancy Rating Scale

Time Frame: 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)

Time Frame: Week 11

Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.

Feasibility-Intervention adherence

Time Frame: Week 11

The percentage of completed sessions

Secondary Outcomes

  • Patient-Reported Outcomes Measurement Information System (PROMIS)(baseline, week 6, week 11)
  • Generalized Anxiety Disorder scale (GAD-7)(Week 6)
  • Insomnia Sleep Index(baseline, week 6, week 11)
  • Feasibility-Client Satisfaction Questionnaire(Week 11)
  • Feasibility-Working Alliance Inventory, Client(Week 11)
  • Feasibility-Working Alliance Inventory, Therapist(Week 11)
  • Penn State Worry Questionnaire-Abbreviated (PSWQ-A)(week 6)

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