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

November 12, 2010
July 14, 2014
January 2011
February 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01259596 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
Behavioral: psychotherapy
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Other Name: therapy
  • 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
    Intervention: Behavioral: psychotherapy
  • 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
    Intervention: Behavioral: psychotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01259596
1R01MH083664, R01MH083664
Yes
Gretchen Brenes, Wake Forest Baptist Health
Wake Forest Baptist Health
National Institute of Mental Health (NIMH)
Principal Investigator: Gretchen A. Brenes, Ph.D. Wake Forest School of Medicine
Wake Forest Baptist Health
July 2014

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