Trial Outcomes & Findings for Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression (NCT NCT01922219)

NCT ID: NCT01922219

Last Updated: 2017-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy 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 Study STARTED	37
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy n=37 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=37 Participants 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
Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10	13 Participants

SECONDARY outcome

Timeframe: Post-Treatment, up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=37 Participants 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
Post-Treatment Beck Depression Inventory	15.4 Score on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Post-Treatment, up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=37 Participants 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
Final Score on the Hamilton Depression Rating Scale	13.41 units on a scale Standard Deviation 6.61

Adverse Events

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cognitive Behavioral Therapy n=37 participants at risk 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
Injury, poisoning and procedural complications Knee Pain during MRI	2.7% 1/37 • Number of events 1

Additional Information

Jeffrey Miller, M.D.

NYSPI

Phone: 646-774-7613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place