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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: December 8, 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):
Wake Forest University Health Sciences
Results First Submitted: January 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Behavioral: cognitive behavioral therapy
Behavioral: nondirective supportive therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

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

psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions


Participant Flow:   Overall Study
    Cognitive-behavioral Therapy   Nondirective Supportive Therapy
STARTED   70   71 
COMPLETED   66   65 
NOT COMPLETED   4   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

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

psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Total Total of all reporting groups

Baseline Measures
   Cognitive-behavioral Therapy   Nondirective Supportive Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   71   141 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      41  58.6%      34  47.9%      75  53.2% 
>=65 years      29  41.4%      37  52.1%      66  46.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      58  82.9%      57  80.3%      115  81.6% 
Male      12  17.1%      14  19.7%      26  18.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      70 100.0%      71 100.0%      141 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   5.7%      2   2.8%      6   4.3% 
White      64  91.4%      64  90.1%      128  90.8% 
More than one race      2   2.9%      5   7.0%      7   5.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   70   71   141 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13   [ Time Frame: baseline to week 13 ]

2.  Primary:   Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13   [ Time Frame: baseline to week 13 ]

3.  Secondary:   Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks   [ Time Frame: baseline to week 13 ]

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

5.  Secondary:   Short Form (36) Health Survey (SF-36) to Week 13   [ Time Frame: week 13 ]

6.  Secondary:   Insomnia Severity Index (ISI)   [ Time Frame: week 13 ]

7.  Secondary:   Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13   [ Time Frame: baseline to week 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gretchen A. Brenes, Ph.D.
Organization: Wake Forest School of Medicine
phone: 336-716-4551
e-mail: gbrenes@wakehealth.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01259596     History of Changes
Other Study ID Numbers: 1R01MH083664 ( U.S. NIH Grant/Contract )
R01MH083664 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2010
First Posted: December 14, 2010
Results First Submitted: January 7, 2016
Results First Posted: October 3, 2017
Last Update Posted: December 8, 2017