Cognitive Therapy for Recurrent Depression

Depression Clinical Trial

Official title:

Prophylactic Cognitive Therapy for Depression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118404
• Other study ID #: R01MH058397
• Secondary ID: R01MH058397R01MH
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2005
• Last updated: May 13, 2014
• Start date: March 2000
• Est. completion date: July 2008

Study information

• Verified date: May 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

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

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

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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 — View 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 — View 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. JAM — View 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. — View 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. — View 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. — View 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.2011.1 — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Measured at month 8	No
Primary	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)	Measured at month 20	No
Primary	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).	Measured at month 32	No

External Links

•   Psychosocial Research and Depression Clinic