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Trial record 1 of 5463 for:    "Depressive Disorder" [DISEASE] AND Behavioral
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Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

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ClinicalTrials.gov Identifier: NCT01922219
Recruitment Status : Completed
First Posted : August 14, 2013
Results First Posted : March 1, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Behavioral: Cognitive Behavioral Therapy
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Period Title: Overall Study
Started 37
Completed 28
Not Completed 9
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  97.3%
>=65 years
1
   2.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
36  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
24
  64.9%
Male
13
  35.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
6
  16.2%
Not Hispanic or Latino
27
  73.0%
Unknown or Not Reported
4
  10.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  10.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   8.1%
White
22
  59.5%
More than one race
3
   8.1%
Unknown or Not Reported
5
  13.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
 100.0%
1.Primary Outcome
Title Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10
Hide Description The primary outcome of this study is remission from depression at the conclusion of 12 weeks of cognitive behavioral therapy for depression. This will be assessed using the Beck Depression Inventory, a self-report questionnaire of symptoms of depression that will be administered at every treatment visit. Remission is defined by a final Beck Depression Inventory score less than or equal to 10.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description:

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
13
  35.1%
2.Secondary Outcome
Title Post-Treatment Beck Depression Inventory
Hide Description

The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression.

The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex.

We report the total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale’s manual:

0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression

Time Frame Post-Treatment, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description:

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: Score on a scale
15.4  (9.5)
3.Secondary Outcome
Title Final Score on the Hamilton Depression Rating Scale
Hide Description

Final score on the Hamilton Depression Rating Scale (HDRS) was calculated for 37 patients who were treated with Cognitive Behavioral Therapy.

The 17-item HDRS is a clinician-administered scale that quantifies depression severity, and includes items assessing mood, suicidal thinking, insomnia, feelings of guilt, work and activities, somatic symptoms, and insight. It is a well-characterized scale with excellent psychometric properties. The total score is the sum of the individual scores of the 17 scale items. Higher scores indicate greater depression severity. When using this outcome measure, we covary for baseline HDRS scores. Published norms for interpretation of the 17-item HDRS use a different version of the scale with a total possible score of 52, and are listed below. Interpretation is comparable (but not identical) with the 17-item HDRS version used in this study, which has a maximum score is 51.

None: 0-7 Mild: 8-13 Moderate: 14-19 Severe: 20-25 Very Severe: 26-52

Time Frame Post-Treatment, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description:

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.41  (6.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Therapy
Hide Arm/Group Description

Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).

Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

All-Cause Mortality
Cognitive Behavioral Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Therapy
Affected / at Risk (%) # Events
Total   0/37 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioral Therapy
Affected / at Risk (%) # Events
Total   1/37 (2.70%)    
Injury, poisoning and procedural complications   
Knee Pain during MRI * [1]  1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
[1]
During an MRI, a subject developed mild unilateral knee pain similar to pain she had experienced in the past, and subsequently developed some stiffness and swelling in this knee. The IRB concluded that the event was neither serious nor study related.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Miller, M.D.
Organization: NYSPI
Phone: 646-774-7613
EMail: jm2233@cumc.columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01922219     History of Changes
Other Study ID Numbers: #6127
5K08MH085061 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2013
First Posted: August 14, 2013
Results First Submitted: December 22, 2016
Results First Posted: March 1, 2017
Last Update Posted: September 19, 2017