Back to resultsCognitive Therapy for Recurrent Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Continuation phase cognitive therapy
Continuation phase fluoxetine
Continuation phase pill placebo
Acute phase cognitive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Cognitive therapy, Antidepressants, Psychotherapy
Eligibility Criteria
Inclusion Criteria: Recurrent unipolar major depressive disorder Have experienced at least two episodes of major depression Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes Willing and able to comply with all study requirements Able to speak and read English Exclusion Criteria: Active alcohol or other substance dependence within 6 months prior to study entry Currently at risk for suicide Mood disorders due to a medical condition or substance abuse Bipolar, schizoaffective, obsessive compulsive, or eating disorders Schizophrenia Unable to stop mood-altering medications Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis) Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac Pregnancy or plan to become pregnant in the next 11-12 months Unable to attend clinic twice weekly during business hours Unable to complete questionnaires
Sites / Locations
- University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
- University of Texas Southwestern Medical Center at Dallas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Participants received acute phase and continuation phase cognitive therapy
Participants received acute phase cognitive therapy and continuation phase pill placebo
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Outcomes
Primary Outcome Measures
Depressive Relapse or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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)
Depressive Relapse/Recurrence or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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)
Depressive Relapse/Recurrence or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00118404
First Posted
July 6, 2005
Last Updated
May 13, 2014
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00118404
Brief Title
Cognitive Therapy for Recurrent Depression
Official Title
Prophylactic Cognitive Therapy for Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.
Detailed Description
Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.
This study lasted approximately 36 months and comprised three phases. For the first 12 weeks, all participants received between 16 and 20 CT sessions. Participants were then randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Cognitive therapy, Antidepressants, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
523 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants received acute phase and continuation phase cognitive therapy
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants received acute phase cognitive therapy and continuation phase pill placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Intervention Type
Behavioral
Intervention Name(s)
Continuation phase cognitive therapy
Intervention Description
Continuation phase cognitive therapy included 10 sessions over 8 months.
Intervention Type
Drug
Intervention Name(s)
Continuation phase fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
The dosage of fluoxetine was increased to 40 mg over 8 months.
Intervention Type
Other
Intervention Name(s)
Continuation phase pill placebo
Intervention Description
The dosage of pill placebo was increased to 40 mg over 8 months.
Intervention Type
Behavioral
Intervention Name(s)
Acute phase cognitive therapy
Intervention Description
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Primary Outcome Measure Information:
Title
Depressive Relapse or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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
Title
Depressive Relapse/Recurrence or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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
Title
Depressive Relapse/Recurrence or MDD
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:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent unipolar major depressive disorder
Have experienced at least two episodes of major depression
Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
Willing and able to comply with all study requirements
Able to speak and read English
Exclusion Criteria:
Active alcohol or other substance dependence within 6 months prior to study entry
Currently at risk for suicide
Mood disorders due to a medical condition or substance abuse
Bipolar, schizoaffective, obsessive compulsive, or eating disorders
Schizophrenia
Unable to stop mood-altering medications
Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
Pregnancy or plan to become pregnant in the next 11-12 months
Unable to attend clinic twice weekly during business hours
Unable to complete questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin B. Jarrett, PhD
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20451668
Citation
Jarrett RB, Thase ME. Comparative efficacy and durability of continuation phase cognitive therapy for preventing recurrent depression: design of a double-blinded, fluoxetine- and pill placebo-controlled, randomized trial with 2-year follow-up. Contemp Clin Trials. 2010 Jul;31(4):355-77. doi: 10.1016/j.cct.2010.04.004. Epub 2010 May 6.
Results Reference
background
PubMed Identifier
21319902
Citation
Jarrett RB, Vittengl JR, Clark LA, Thase ME. Skills of Cognitive Therapy (SoCT): a new measure of patients' comprehension and use. Psychol Assess. 2011 Sep;23(3):578-86. doi: 10.1037/a0022485.
Results Reference
result
PubMed Identifier
21781377
Citation
Dunn TW, Vittengl JR, Clark LA, Carmody T, Thase ME, Jarrett RB. Change in psychosocial functioning and depressive symptoms during acute-phase cognitive therapy for depression. Psychol Med. 2012 Feb;42(2):317-26. doi: 10.1017/S0033291711001279. Epub 2011 Jul 25.
Results Reference
result
PubMed Identifier
22398963
Citation
Smits JA, Minhajuddin A, Thase ME, Jarrett RB. Outcomes of acute phase cognitive therapy in outpatients with anxious versus nonanxious depression. Psychother Psychosom. 2012;81(3):153-60. doi: 10.1159/000334909. Epub 2012 Mar 3.
Results Reference
result
PubMed Identifier
22306232
Citation
Renner F, Jarrett RB, Vittengl JR, Barrett MS, Clark LA, Thase ME. Interpersonal problems as predictors of therapeutic alliance and symptom improvement in cognitive therapy for depression. J Affect Disord. 2012 May;138(3):458-67. doi: 10.1016/j.jad.2011.12.044. Epub 2012 Feb 4.
Results Reference
result
PubMed Identifier
22445946
Citation
Jarrett RB, Minhajuddin A, Borman PD, Dunlap L, Segal ZV, Kidner CL, Friedman ES, Thase ME. Cognitive reactivity, dysfunctional attitudes, and depressive relapse and recurrence in cognitive therapy responders. Behav Res Ther. 2012 May;50(5):280-6. doi: 10.1016/j.brat.2012.01.008. Epub 2012 Feb 21.
Results Reference
result
PubMed Identifier
23305218
Citation
Brandon AR, Minhajuddin A, Thase ME, Jarrett RB. Impact of reproductive status and age on response of depressed women to cognitive therapy. J Womens Health (Larchmt). 2013 Jan;22(1):58-66. doi: 10.1089/jwh.2011.3427.
Results Reference
result
PubMed Identifier
23485420
Citation
Jarrett RB, Minhajuddin A, Kangas JL, Friedman ES, Callan JA, Thase ME. Acute phase cognitive therapy for recurrent major depressive disorder: who drops out and how much do patient skills influence response? Behav Res Ther. 2013 May;51(4-5):221-30. doi: 10.1016/j.brat.2013.01.006.
Results Reference
result
PubMed Identifier
24005123
Citation
Jarrett RB, Minhajuddin A, Gershenfeld H, Friedman ES, Thase ME. Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo. JAMA Psychiatry. 2013 Nov;70(11):1152-60. doi: 10.1001/jamapsychiatry.2013.1969.
Results Reference
result
PubMed Identifier
23627652
Citation
Vittengl JR, Clark LA, Thase ME, Jarrett RB. Nomothetic and idiographic symptom change trajectories in acute-phase cognitive therapy for recurrent depression. J Consult Clin Psychol. 2013 Aug;81(4):615-26. doi: 10.1037/a0032879. Epub 2013 Apr 29.
Results Reference
result
PubMed Identifier
23786268
Citation
Vittengl JR, Clark LA, Thase ME, Jarrett RB. Replication and extension: separate personality traits from states to predict depression. J Pers Disord. 2014 Apr;28(2):225-46. doi: 10.1521/pedi_2013_27_117. Epub 2013 Jun 20.
Results Reference
result
PubMed Identifier
30824246
Citation
Callan JA, Kazantzis N, Park SY, Moore CG, Thase ME, Minhajuddin A, Kornblith S, Siegle GJ. A Propensity Score Analysis of Homework Adherence-Outcome Relations in Cognitive Behavioral Therapy for Depression. Behav Ther. 2019 Mar;50(2):285-299. doi: 10.1016/j.beth.2018.05.010. Epub 2018 Jun 5.
Results Reference
derived
PubMed Identifier
26348032
Citation
Brown GK, Thase ME, Vittengl JR, Borman PD, Clark LA, Jarrett RB. Assessing cognitive therapy skills comprehension, acquisition, and use by means of an independent observer version of the Skills of Cognitive Therapy (SoCT-IO). Psychol Assess. 2016 Feb;28(2):205-13. doi: 10.1037/pas0000080. Epub 2015 Sep 7.
Results Reference
derived
PubMed Identifier
24643964
Citation
Horner MS, Siegle GJ, Schwartz RM, Price RB, Haggerty AE, Collier A, Friedman ES. C'mon get happy: reduced magnitude and duration of response during a positive-affect induction in depression. Depress Anxiety. 2014 Nov;31(11):952-60. doi: 10.1002/da.22244. Epub 2014 Mar 18.
Results Reference
derived
Links:
URL
http://www.utsouthwestern.edu/utsw/home/research/prdc/indec.html
Description
Psychosocial Research and Depression Clinic
Learn more about this trial
Cognitive Therapy for Recurrent Depression
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