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Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy
nondirective supportive therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring anxiety, rural, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years GAD Reside in rural county Proficient in English

Exclusion Criteria:

Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive behavioral therapy

Nondirective supportive therapy

Arm Description

Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention

Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings

Outcomes

Primary Outcome Measures

Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.

Secondary Outcome Measures

Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks
self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.
Pepper Center Tool for Disability (PCT-D)
self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.
Short Form (36) Health Survey (SF-36) to Week 13
physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.
Insomnia Severity Index (ISI)
self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes
Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13
Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome

Full Information

First Posted
November 12, 2010
Last Updated
July 30, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01259596
Brief Title
Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)
Official Title
A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive therapy delivered by telephone are effective for reducing worry and anxiety in rural older adults with Generalized Anxiety Disorder (GAD).
Detailed Description
Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered in a workbook format and by telephone, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults ≥ 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy. The 2 primary treatment outcomes are anxiety symptoms as assessed by the Hamilton Anxiety Rating Scale, and worry symptoms as assessed by the Penn State Worry Questionnaire-Abbreviated. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
anxiety, rural, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
Arm Title
Nondirective supportive therapy
Arm Type
Active Comparator
Arm Description
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Other Intervention Name(s)
CBT
Intervention Description
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Intervention Type
Behavioral
Intervention Name(s)
nondirective supportive therapy
Other Intervention Name(s)
NST
Intervention Description
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Primary Outcome Measure Information:
Title
Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
Description
self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Time Frame
baseline to week 13
Title
Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
Description
interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.
Time Frame
baseline to week 13
Secondary Outcome Measure Information:
Title
Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks
Description
self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.
Time Frame
baseline to week 13
Title
Pepper Center Tool for Disability (PCT-D)
Description
self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.
Time Frame
week 13
Title
Short Form (36) Health Survey (SF-36) to Week 13
Description
physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.
Time Frame
week 13
Title
Insomnia Severity Index (ISI)
Description
self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes
Time Frame
week 13
Title
Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13
Description
Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome
Time Frame
baseline to week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 years GAD Reside in rural county Proficient in English Exclusion Criteria: Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen A. Brenes, Ph.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26244854
Citation
Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Telephone-Delivered Cognitive Behavioral Therapy and Telephone-Delivered Nondirective Supportive Therapy for Rural Older Adults With Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Oct;72(10):1012-20. doi: 10.1001/jamapsychiatry.2015.1154.
Results Reference
derived
PubMed Identifier
24506950
Citation
Brenes GA, Danhauer SC, Lyles MF, Miller ME. Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial. BMC Psychiatry. 2014 Feb 8;14:34. doi: 10.1186/1471-244X-14-34.
Results Reference
derived

Learn more about this trial

Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)

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