Generalized Anxiety DisorderNCT05380115
Cognitive Behavioral Therapy (CBT) for Late Life Anxiety
A study testing Cognitive Behavioral Therapy (CBT) in people with Generalized Anxiety Disorder, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- diagnosis of dementia or cognitive impairment in the problem list
About this study
Official title: Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT)
- Keywords
- late-life anxiety, aging, cognitive-behavioral therapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
weekly one on one video or telephone interviews with a study coach
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | All subjects enrolled received CBT for 10 weeks. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 1
Feasibility-Intervention adherence
The percentage of completed sessions
Measured: Week 11
Feasibility-Number of participants who complete at least 75% of sessions
Measured: Week 11
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: The investigators were running out of time on a 1 year pilot grant and had to prioritize other parts of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen Brenes, PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380115
- Sponsor's protocol ID
- IRB00084483
- Status last verified
- May 2024
- First submitted
- 12 May 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05380115
- Acronym / sponsor ID
- IRB00084483
- Conditions
- Generalized Anxiety Disorder
- Keywords
- late-life anxiety, aging, cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators were running out of time on a 1 year pilot grant and had to prioritize other parts of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)All subjects enrolled received CBT for 10 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- diagnosis of dementia or cognitive impairment in the problem list
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)weekly one on one video or telephone interviews with a study coach | Behavioural | CBT |
Primary outcome
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.
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.
Feasibility-Intervention adherence
Time frame: Week 11
The percentage of completed sessions
Feasibility-Number of participants who complete at least 75% of sessions
Time frame: Week 11
9 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: baseline, week 6, week 11
Insomnia Sleep Index
Time frame: baseline, week 6, week 11
Feasibility-Client Satisfaction Questionnaire
Time frame: Week 11
Feasibility-Working Alliance Inventory, Client
Time frame: Week 11
Feasibility-Working Alliance Inventory, Therapist
Time frame: Week 11
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Week 6
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Time frame: baseline
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
Time frame: week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Brenes, PhD principal investigator
Atrium Health Wake Forest Baptist
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Generalized Anxiety Disorder, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder scale (GAD-7) (time frame: Week 11). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.