| ID | Type | Description | Link |
|---|---|---|---|
| R01MH058397 | U.S. NIH Grant/Contract | View source | |
| R01MH069619 | U.S. NIH Grant/Contract | View source | |
| R01MH058356 | U.S. NIH Grant/Contract | View source | |
| R01MH069618 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants received acute phase and continuation phase cognitive therapy |
|
| 2 | Placebo Comparator | Participants received acute phase cognitive therapy and continuation phase pill placebo |
|
| 3 | Active Comparator | Participants received acute phase cognitive therapy and continuation phase fluoxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuation phase cognitive therapy | Behavioral | Continuation phase cognitive therapy included 10 sessions over 8 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) | Measured at month 8 |
| 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:
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) | Measured at month 20 |
| 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:
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin B. Jarrett, PhD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20451668 | Background | 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. | |
| 21319902 | Result | 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. |
| Label | URL |
|---|---|
| Psychosocial Research and Depression Clinic | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuation Phase Fluoxetine | 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. |
| FG001 | Continuation Phase Cognitive Therapy | 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. |
| FG002 | Continuation Phase Pill Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuation Phase Fluoxetine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) | Intention to treat analysis | Posted | Number | % patients who relapsed | Measured at month 8 |
|
32 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuation Phase Fluoxetine | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin B. Jarrett, Professor of Psychiatry | The University of Texas Southwestern Medical Center | 214-648-5345 | Robin.Jarrett@UTSouthwestern.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Continuation phase fluoxetine | Drug | The dosage of fluoxetine was increased to 40 mg over 8 months. |
|
|
| Continuation phase pill placebo | Other | The dosage of pill placebo was increased to 40 mg over 8 months. |
|
| Acute phase cognitive therapy | Behavioral | For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. |
|
| Measured at month 32 |
| University of Texas Southwestern Medical Center at Dallas |
| Dallas |
| Texas |
| 75390 |
| United States |
| 21781377 | Result | 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. |
| 22398963 | Result | 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. |
| 22306232 | Result | 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. |
| 22445946 | Result | 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. |
| 23305218 | Result | 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. |
| 23485420 | Result | 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. |
| 24005123 | Result | 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. |
| 23627652 | Result | 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. |
| 23786268 | Result | 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. |
| 30824246 | Derived | 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. |
| 26348032 | Derived | 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. |
| 24643964 | Derived | 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. |
| BG001 |
| Continuation Phase Cognitive Therapy |
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. |
| BG002 | Continuation Phase Pill Placebo | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
| OG001 | Continuation Phase Cognitive Therapy | 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. |
| OG002 | Continuation Phase Pill Placebo | 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. |
|
|
|
| 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:
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) | Intention to treat analysis | Posted | Number | % patients who relapsed/recurred | Measured at month 20 |
|
|
|
|
| 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:
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481). | Intention to treat analysis | Posted | Number | % patients who relapsed/recurred | Measured at month 32 |
|
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Continuation Phase Cognitive Therapy | 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. | 0 | 86 | 0 | 86 |
| EG002 | Continuation Phase Pill Placebo | 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. | 0 | 69 | 0 | 69 |
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| Log Rank |
Chi-square = 1.19, df = 1 |
| .14 |
| Hazard Ratio (HR) |
| .717 |
| Standard Error of the Mean |
| .31 |
| 2-Sided |
| 95 |
| .39 |
| 1.31 |
Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm. |
| No |
| Superiority or Other |
| Log Rank | chi-square = 1.262, df = 1 | .13 | Hazard Ratio (HR) | .715 | Standard Error of the Mean | .30 | 2-Sided | 95 | .40 | 1.29 | 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. | No | Superiority or Other |
| Log Rank | Chi-square = 1.595, df = 1 | .10 | Hazard Ratio (HR) | .717 | Standard Error of the Mean | .26 | 2-Sided | 95 | .43 | 1.20 | Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm. | No | Superiority or Other |
| Log Rank |
chi-square = 2.407, df = 1 |
| .61 |
| Hazard Ratio (HR) |
| .649 |
| Standard Error of the Mean |
| .28 |
| 2-Sided |
| 95 |
| .37 |
| 1.13 |
Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported. |
| No |
| Superiority or Other |
| Log Rank | chi-square = 1.731, df = 1 | .09 | Hazard Ratio (HR) | .701 | Standard Error of the Mean | .27 | 2-Sided | 95 | .41 | 1.19 | Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported. | No | Superiority or Other |
| Log Rank | chi-square = 2.705, df = 1 | .05 | Hazard Ratio, log | .676 | Standard Error of the Mean | .24 | 2-Sided | 95 | .42 | 1.08 | Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported. | No | Superiority or Other |