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

Cognitive Therapy for Recurrent Depression

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: NCT00118404
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robin Jarrett, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Behavioral: Continuation phase cognitive therapy
Drug: Continuation phase fluoxetine
Other: Continuation phase pill placebo
Behavioral: Acute phase cognitive therapy
Enrollment 523
Recruitment Details Adult outpatients diagnosed with recurrent major depressive disorder (MDD) using the Structured Clinical Interview for Diagnostic and Statistical Manual-IV were recruited from January 2000-July 2008. The first diagnostic evaluation was completed in March 2000.
Pre-assignment Details Eligible patients (n=523) entered 12-14 weeks of acute phase cognitive therapy. Responders (no MDD & Hamilton Rating Scale for Depression [HRSD] ≤12) were divided by lower & higher risk based on the final 7 HRSD scores. Only consenting, higher risk patients (N=241) were randomized into the 3 arms below. See Jarrett &Thase (2010) for design details.
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Hide Arm/Group Description

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Period Title: Overall Study
Started 86 86 69
Completed 62 70 49
Not Completed 24 16 20
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo Total
Hide Arm/Group Description

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Total of all reporting groups
Overall Number of Baseline Participants 86 86 69 241
Hide Baseline Analysis Population Description
523 adults with recurrent major depressive disorder began acute phase cognitive therapy; only the 241 eligible higher-risk responders were randomized to the 3 arms above.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 69 participants 241 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
86
 100.0%
86
 100.0%
69
 100.0%
241
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 69 participants 241 participants
41.6  (11.8) 43.1  (11.5) 43.6  (12.3) 42.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 69 participants 241 participants
Female
57
  66.3%
63
  73.3%
42
  60.9%
162
  67.2%
Male
29
  33.7%
23
  26.7%
27
  39.1%
79
  32.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 86 participants 69 participants 241 participants
86 86 69 241
1.Primary Outcome
Title Depressive Relapse or MDD
Hide Description

Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment

LIFE-PSR Scale:

  1. = No residual symptoms, no current evidence of the disorder.
  2. = Mild symptoms
  3. = Considerably less psychopathology than full criteria with no more than moderate impairment
  4. = Does not meet full criteria but has major symptoms of impairment
  5. = Meets criteria without extreme impairment in functioning
  6. = Meets criteria with extreme impairment in functioning

The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)

Time Frame Measured at month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Hide Arm/Group Description:

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Overall Number of Participants Analyzed 86 86 69
Measure Type: Number
Unit of Measure: % patients who relapsed
18 18.3 32.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy
Comments The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .42
Comments [Not Specified]
Method Log Rank
Comments log-rank chi-square = 0.038, df = 1, p <=.42
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.079
Confidence Interval (2-Sided) 95%
0.50 to 2.34
Parameter Dispersion
Type: Standard Error of the mean
Value: .39
Estimation Comments Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Log Rank
Comments log-rank chi-square = 3.92, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .481
Confidence Interval (2-Sided) 95%
.23 to 1.01
Parameter Dispersion
Type: Standard Error of the mean
Value: .38
Estimation Comments Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Log Rank
Comments log-rank chi-square = 3.391, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.519
Confidence Interval (2-Sided) 95%
0.26 to 1.06
Parameter Dispersion
Type: Standard Error of the mean
Value: .36
Estimation Comments Hazard ratio for relapse in C-CT group compared to that in the placebo group.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method Log Rank
Comments log-rank chi-square = 5.06, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.501
Confidence Interval (2-Sided) 95%
0.27 to 0.93
Parameter Dispersion
Type: Standard Error of the mean
Value: .31
Estimation Comments Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.
2.Primary Outcome
Title Depressive Relapse/Recurrence or MDD
Hide Description

Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment

LIFE-PSR Scale:

  1. = No residual symptoms, no current evidence of the disorder.
  2. = Mild symptoms
  3. = Considerably less psychopathology than full criteria with no more than moderate impairment
  4. = Does not meet full criteria but has major symptoms of impairment
  5. = Meets criteria without extreme impairment in functioning
  6. = Meets criteria with extreme impairment in functioning

Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)

Time Frame Measured at month 20
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Hide Arm/Group Description:

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Overall Number of Participants Analyzed 86 86 69
Measure Type: Number
Unit of Measure: % patients who relapsed/recurred
35.1 35.0 42.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .48
Comments [Not Specified]
Method Log Rank
Comments log-rank chi-square = 0.002, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.988
Confidence Interval (2-Sided) 95%
0.55 to 1.76
Parameter Dispersion
Type: Standard Error of the mean
Value: .30
Estimation Comments Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments [Not Specified]
Method Log Rank
Comments Chi-square = 1.19, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .717
Confidence Interval (2-Sided) 95%
.39 to 1.31
Parameter Dispersion
Type: Standard Error of the mean
Value: .31
Estimation Comments Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .13
Comments [Not Specified]
Method Log Rank
Comments chi-square = 1.262, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .715
Confidence Interval (2-Sided) 95%
.40 to 1.29
Parameter Dispersion
Type: Standard Error of the mean
Value: .30
Estimation Comments Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .10
Comments [Not Specified]
Method Log Rank
Comments Chi-square = 1.595, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .717
Confidence Interval (2-Sided) 95%
.43 to 1.20
Parameter Dispersion
Type: Standard Error of the mean
Value: .26
Estimation Comments Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.
3.Primary Outcome
Title Depressive Relapse/Recurrence or MDD
Hide Description

Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment

LIFE-PSR Scale:

  1. = No residual symptoms, no current evidence of the disorder.
  2. = Mild symptoms
  3. = Considerably less psychopathology than full criteria with no more than moderate impairment
  4. = Does not meet full criteria but has major symptoms of impairment
  5. = Meets criteria without extreme impairment in functioning
  6. = Meets criteria with extreme impairment in functioning

Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481).

Time Frame Measured at month 32
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Hide Arm/Group Description:

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Overall Number of Participants Analyzed 86 86 69
Measure Type: Number
Unit of Measure: % patients who relapsed/recurred
41.1 45.2 56.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .40
Comments [Not Specified]
Method Log Rank
Comments chi-square = .07, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.075
Confidence Interval (2-Sided) 95%
.63 to 1.84
Parameter Dispersion
Type: Standard Error of the mean
Value: .27
Estimation Comments Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .61
Comments [Not Specified]
Method Log Rank
Comments chi-square = 2.407, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .649
Confidence Interval (2-Sided) 95%
.37 to 1.13
Parameter Dispersion
Type: Standard Error of the mean
Value: .28
Estimation Comments Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .09
Comments [Not Specified]
Method Log Rank
Comments chi-square = 1.731, df = 1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .701
Confidence Interval (2-Sided) 95%
.41 to 1.19
Parameter Dispersion
Type: Standard Error of the mean
Value: .27
Estimation Comments Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Continuation Phase Fluoxetine, Continuation Phase Cognitive Therapy, Continuation Phase Pill Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method Log Rank
Comments chi-square = 2.705, df = 1
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value .676
Confidence Interval (2-Sided) 95%
.42 to 1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: .24
Estimation Comments Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.
Time Frame 32 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Hide Arm/Group Description

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

All-Cause Mortality
Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%)   0/69 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuation Phase Fluoxetine Continuation Phase Cognitive Therapy Continuation Phase Pill Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%)   0/69 (0.00%) 

To our knowledge in 2014 this is of the largest, cognitive therapy responders who presented with recurrent MDD and were followed longitudinally

Proficient therapists;competency measured.

Generalizability is limited by design characteristics.

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: Dr. Robin B. Jarrett, Professor of Psychiatry
Organization: The University of Texas Southwestern Medical Center
Phone: 214-648-5345
EMail: Robin.Jarrett@UTSouthwestern.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00118404    
Obsolete Identifiers: NCT00183664, NCT00218764
Other Study ID Numbers: R01MH058397 ( U.S. NIH Grant/Contract )
R01MH058397 ( U.S. NIH Grant/Contract )
R01MH069619 ( U.S. NIH Grant/Contract )
R01MH058356 ( U.S. NIH Grant/Contract )
R01MH069618 ( U.S. NIH Grant/Contract )
First Submitted: July 6, 2005
First Posted: July 11, 2005
Results First Submitted: December 12, 2013
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014