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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gretchen Brenes, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01259596
First received: November 12, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 Baptist Health:

Primary Outcome Measures:
  • Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    worry

  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    interviewer-rated anxiety symptoms


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    depression

  • Pepper Center Tool for Disability (PCT-D) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    disability

  • Short Form (36) Health Survey (SF-36) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    quality of life

  • Insomnia Severity Index (ISI) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    sleep

  • GAD-7 [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    DSM-IV symptoms


Enrollment: 141
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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 ClinicalTrials.gov identifier: NCT01259596

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Gretchen A. Brenes, Ph.D. Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest Baptist Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gretchen Brenes, Associate Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT01259596     History of Changes
Other Study ID Numbers: 1R01MH083664, R01MH083664
Study First Received: November 12, 2010
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
anxiety
rural
elderly

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014