Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

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.
 
ClinicalTrials.gov Identifier: NCT00223652
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 17, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depressive Disorder
Depression
Intervention Behavioral: Telephone cognitive behavioral therapy
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Period Title: T-CBT 12 Weeks, TAU 20 Weeks
Started 41 44
Completed 40 41
Not Completed 1 3
Period Title: T-CBT 20 Weeks, TAU 20 Weeks
Started 40 41
Completed 40 41
Not Completed 0 0
Period Title: T-CBT and TAU 6 Month Follow-up
Started 40 41
Completed 39 37
Not Completed 1 4
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual Total
Hide Arm/Group Description

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control. Total of all reporting groups
Overall Number of Baseline Participants 41 44 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 44 participants 85 participants
56.83  (10.81) 54.98  (10.42) 55.9  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 85 participants
Female
3
   7.3%
5
  11.4%
8
   9.4%
Male
38
  92.7%
39
  88.6%
77
  90.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 85 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
0
   0.0%
0
   0.0%
0
   0.0%
White
33
  80.5%
34
  77.3%
67
  78.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
  19.5%
10
  22.7%
18
  21.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 44 participants 85 participants
41 44 85
1.Primary Outcome
Title Change in Severity of Depression Using Hamilton Depression Rating Scale
Hide Description

Evaluators administered the Hamilton Depression Rating Scale(Ham-D).

Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D).

Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.

Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Time Frame Baseline, 12 weeks, 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 41 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n = 41, n = 44, respectively 20.83  (3.96) 19.23  (3.72)
Week 12, n = 40, n = 41 respectively 16.71  (6.42) 17.27  (5.29)
Week 20, n = 40, n =41, respectively 15.43  (5.51) 17.00  (5.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Change in Severity of Depression Using the Patient Health Questionnaire-9
Hide Description

Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9).

Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.

PHQ-9 score ranges from 0-27, higher values indicate more severe depression.

Time Frame Baseline, Week 12, Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 41 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n = 41, n = 44, respectively 17.12  (5.10) 17.39  (4.79)
Week 12, n = 40, n = 41, respectively 12.19  (5.96) 14.35  (6.05)
Week 20, n = 40, n = 41, respectively 11.15  (6.46) 12.90  (5.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Meeting Criteria for Major Depressive Disorder
Hide Description Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.
Time Frame Baseline to week 12, and week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 41 44
Measure Type: Number
Unit of Measure: participants
number of particpants with MDE at Baseline 41 44
number of particpants with MDE Week 12 20 29
number of particpants with MDE Week 20 19 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Generalized estimating equations models
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Generalized estimating equations models
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Generalized estimating equations models
Comments [Not Specified]
4.Secondary Outcome
Title Maintenance of Treatment Effect
Hide Description

Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.

Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Time Frame 6 month follow-up (week 44)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.62  (6.36) 14.81  (5.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone-administered Cognitive-Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.37
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Maintenance of Treatment Effect
Hide Description

6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9).

Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9.

PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.

Time Frame 6-month post treatment follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Cognitive Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.25  (6.67) 12.26  (5.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone Cognitive Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.37
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up
Hide Description

Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE).

A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.

Time Frame 6-month follow up at week 44 post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Cognitive Behavioral Therapy Treatment as Usual
Hide Arm/Group Description:

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
Overall Number of Participants Analyzed 39 37
Measure Type: Number
Unit of Measure: participants
16 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone Cognitive Behavioral Therapy, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.37
Comments [Not Specified]
Method Generalized estimating equations models
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Hide Arm/Group Description

Telephone cognitive behavioral therapy

Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Treatment as usual control.
All-Cause Mortality
Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telephone-administered Cognitive-Behavioral Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/44 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: David C. Mohr
Organization: Northwestern University
Phone: 312- 503-1403
EMail: d-mohr@northwestern.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00223652    
Other Study ID Numbers: IIR 03-069
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: September 9, 2014
Results First Posted: December 17, 2014
Last Update Posted: April 24, 2015