Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gretchen Brenes, Wake Forest Baptist Health Identifier:
First received: November 12, 2010
Last updated: June 15, 2015
Last verified: June 2015
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).

Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: psychotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: week 13 ]

  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: week 13 ]
    interviewer-rated anxiety symptoms

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: week 13 ]

  • Pepper Center Tool for Disability (PCT-D) [ Time Frame: week 13 ]

  • Short Form (36) Health Survey (SF-36) [ Time Frame: week 13 ]
    quality of life

  • Insomnia Severity Index (ISI) [ Time Frame: week 13 ]

  • GAD-7 [ Time Frame: week 13 ]
    DSM-IV symptoms

Enrollment: 141
Study Start Date: January 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
Behavioral: psychotherapy
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Other Name: therapy
Active Comparator: NST
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
Behavioral: psychotherapy
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Other Name: therapy

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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01259596

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Mental Health (NIMH)
Principal Investigator: Gretchen A. Brenes, Ph.D. Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gretchen Brenes, Associate Professor, Wake Forest Baptist Health Identifier: NCT01259596     History of Changes
Other Study ID Numbers: 1R01MH083664 ( US NIH Grant/Contract Award Number )
R01MH083664 ( US NIH Grant/Contract Award Number )
Study First Received: November 12, 2010
Last Updated: June 15, 2015

Keywords provided by Wake Forest University Health Sciences:

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders processed this record on May 22, 2017