We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Treatment for Generalized Anxiety Disorder (GAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620776
First Posted: February 21, 2008
Last Update Posted: February 16, 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):
Paul Crits-Christoph, University of Pennsylvania
Results First Submitted: October 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Behavioral: Cognitive Behavioral Therapy
Drug: Venlafaxine XR

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Three hundred thirty four patients enrolled in the first phase (6-month open-label) of a parent medication trial for GAD (NCT00183274) were recruited and seen in one of four primary care practices or a psychopharmacology clinic in a university setting from 2005 to 2009. The current study was conducted from October, 2006 to March, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 334 patients who consented to the parent trial, 66 did not receive study drug (64 withdrew consent and 2 were protocol violators), leaving 268 who received at least one dose of open-label venlafaxine XR. For this study, 77 patients were randomly assigned to be offered CBT and 40 patients to not be offered CBT.

Reporting Groups
  Description
Combined Treatment Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
Medication Alone Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.

Participant Flow:   Overall Study
    Combined Treatment   Medication Alone
STARTED   29 [1]   40 [2] 
Received at Least One Session/Dose   26 [3]   35 [4] 
COMPLETED   17 [5]   24 [6] 
NOT COMPLETED   12   16 
Did not receive treatment                3                5 
Adverse Event                2                3 
Lack of Efficacy                2                1 
Lost to Follow-up                2                5 
Withdrawal by Subject                3                2 
[1] 29 patients (of the 77 that were randomly assigned to add on CBT) consented to this option.
[2] All 40 patients that were randomly assigned to not be offered CBT consented to this option.
[3] 26 out of 29 that consented to the combined treatment option received at least one session of CBT.
[4] 35 out of 40 that consented to receive medication alone received at least one dose of medication.
[5] 17 out of 26 attended the week 24 (last) assessment.
[6] 24 out of 35 attended the week 24 (last) assessment.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
26 out of 29 patients who consented to receive combined treatment received at least one session of CBT. 35 out of 40 patients who consented to received medication only received at least one dose of medication.

Reporting Groups
  Description
Combined Treatment Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
Medication Alone Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
Total Total of all reporting groups

Baseline Measures
   Combined Treatment   Medication Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   35   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.5  (16.0)   46.6  (19.8)   47.0  (18.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      17  65.4%      18  51.4%      35  57.4% 
Male      9  34.6%      17  48.6%      26  42.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   7.7%      0   0.0%      2   3.3% 
Not Hispanic or Latino      24  92.3%      35 100.0%      59  96.7% 
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      1   3.8%      0   0.0%      1   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  30.8%      10  28.6%      18  29.5% 
White      17  65.4%      25  71.4%      42  68.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   26   35   61 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Anxiety Rating Scale (HAM-A)   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

2.  Secondary:   Hospital Anxiety Depression Scale (HAD)-Anxiety Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

3.  Secondary:   Hospital Anxiety Depression Scale (HAD)-Depression Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

4.  Secondary:   Hamilton Rating Scale for Depression (HAM-D)-17-item Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]

5.  Secondary:   Clinical Global Impression (CGI)-Severity Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Clinical Global Impression (CGI)-Improvement Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

7.  Secondary:   Quality of Life Subscale of the General Health Questionnaire (GHQ)   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]

8.  Secondary:   Penn State Worry Questionnaire (PSWQ)   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]

9.  Secondary:   Physical Component Score of the 12-Item Short Form Survey (SF-12)   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]

10.  Secondary:   Mental Component Score of the 12-item Short Form Survey (SF-12)   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]

11.  Secondary:   Clinical Response Rate   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24 ]

12.  Secondary:   50 Percent or Greater Reduction in PSWQ Score   [ Time Frame: Data collected as part of protocol 709012 at baseline, week 12, and week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Only one-third of those approached to add on CBT were interested in this option. Strict exclusion criteria reduces the generalizability of the study results. Possible that other forms of CBT treatment may produce different results.


  More Information
  Hide More Information

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: Dr. Paul Crits-Christoph
Organization: University of Pennsylvania
phone: (215) 662-7993
e-mail: crits@mail.med.upenn.edu



Responsible Party: Paul Crits-Christoph, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00620776     History of Changes
Other Study ID Numbers: 802307
5R34MH072678-02 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2008
First Posted: February 21, 2008
Results First Submitted: October 31, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017