Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

NCT05380115 | Withdrawn

• 1 other identifier: IRB00084483
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Anxiety Disorder

Keywords

late-life anxiety; aging; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (9)

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  baseline, week 6, week 11

• 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

Other Outcomes (5)

• Healthcare Utilization-Number of Outpatient encounters

  Week 37

• Healthcare Utilization-Number of ED visits

  Week 37

• Healthcare Utilization-Number of inpatient stays

  Week 37

Study Arms (1)

CBT

EXPERIMENTAL

All subjects enrolled received CBT for 10 weeks.

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

weekly one on one video or telephone interviews with a study coach

CBT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• diagnosis of dementia or cognitive impairment in the problem list

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gretchen Brenes, PhD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share