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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259596
First Posted: December 14, 2010
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gretchen Brenes, Wake Forest University Health Sciences
November 12, 2010
December 14, 2010
January 7, 2016
October 3, 2017
October 3, 2017
January 2011
February 2015   (Final data collection date for primary outcome measure)
  • Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13 [ Time Frame: baseline to 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 [ Time Frame: baseline to 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.
  • Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: week 13 ]
    worry
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: week 13 ]
    interviewer-rated anxiety symptoms
Complete list of historical versions of study NCT01259596 on ClinicalTrials.gov Archive Site
  • Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks [ Time Frame: baseline to week 13 ]
    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) [ Time Frame: week 13 ]
    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.
  • Form (36) Health Survey (SF-36) to Week 13 [ Time Frame: 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) [ Time Frame: week 13 ]
    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 [ Time Frame: baseline 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
  • Beck Depression Inventory (BDI) [ Time Frame: week 13 ]
    depression
  • Pepper Center Tool for Disability (PCT-D) [ Time Frame: week 13 ]
    disability
  • Short Form (36) Health Survey (SF-36) [ Time Frame: week 13 ]
    quality of life
  • Insomnia Severity Index (ISI) [ Time Frame: week 13 ]
    sleep
  • GAD-7 [ Time Frame: week 13 ]
    DSM-IV symptoms
Not Provided
Not Provided
 
Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)
A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)
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).
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Behavioral: cognitive behavioral therapy
    weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
    Other Name: CBT
  • Behavioral: nondirective supportive therapy
    weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
    Other Name: NST
  • Active Comparator: Cognitive behavioral therapy
    Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
    Intervention: Behavioral: cognitive behavioral therapy
  • Active Comparator: Nondirective supportive therapy
    Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
    Intervention: Behavioral: nondirective supportive therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
February 2015
February 2015   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01259596
1R01MH083664( U.S. NIH Grant/Contract )
R01MH083664 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Gretchen Brenes, Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Institute of Mental Health (NIMH)
Principal Investigator: Gretchen A. Brenes, Ph.D. Wake Forest University Health Sciences
Wake Forest University Health Sciences
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP