Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder

Sponsor
NYU Langone Health (Other)
Overall Status
Terminated
CT.gov ID
NCT00391430
Collaborator
National Institute of Mental Health (NIMH) (NIH)
39
Enrollment
1
Location
3
Arms
50
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that were once enjoyable, irritability, and sleep problems. Medication therapy, behavioral therapy, and a combination of both therapies are among the available treatment options for people with PTSD. Cognitive behavioral therapy (CBT), a type of talking therapy that has been shown to be effective in treating PTSD, teaches patients how to alter their thinking to, in turn, improve how they feel. A selective serotonin reuptake inhibitor (SSRI) is a type of medication that has also been effective in treating PTSD. Information about the comparative physiological effects of each of these treatments on people with PTSD is needed. This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI treatment in people with PTSD.

Participants with and without PTSD will be enrolled in this 12-week, open label study. Following a screening visit to determine eligibility, participants with PTSD will be offered a choice of either CBT or SSRI treatment. Those participants who choose CBT will attend 16 therapy sessions. The first phase of therapy will focus on the development of emotional and interpersonal regulation skills. The second phase will use a modified form of prolonged exposure therapy, which has been effective in reducing symptoms of PTSD. Participants who elect to receive medication will take sertraline, an SSRI that has been safe and effective in treating PTSD. These participants will attend 12 treatment sessions. Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels. All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning. Other outcomes will be assessed throughout the study using questionnaires.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00648375

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder
Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

ArmIntervention/Treatment
No Intervention: Control

Participants assigned to the control condition will receive no treatment

Active Comparator: Sertraline

Participants will receive treatment with sertraline

Drug: Sertraline
Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks

Active Comparator: CBT

Participants will receive cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy (CBT)
CBT consists of sixteen 1-hour sessions during a period of 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. Salivary Cortisol Levels (Measured Before, During, and After the fMRI) [Measured 3 days before and after treatment and 1 day during fMRI]

    Salivary cortisol levels (measured before, during, and after the fMRI)

  2. Fear Response (Measured During the fMRI) [Measured on 1 day during two MRIs]

    Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli

Secondary Outcome Measures

  1. Trauma History Inventory (THI) [Measured 30 minutes before and after treatment]

    Assesses the full range of traumatic stressor over lifetime

  2. Clinician-Administered PTSD Scale for DSM-IV (CAPS) [Measured 30 minutes before and after treatment]

    Assesses severity and frequency of PTSD symptoms and provides information for diagnosis

  3. Structured Clinical Interview for DSM-IV I and II (SCID I and II) [Measured 1 hour before and after treatment]

    Provides assessment of all anxiety and mood disorder diagnoses

  4. Panic Disorder Severity Scale (PDSS) [Measured 15 minutes before and after treatment]

    measure of frequency and severity of panic attacks

  5. Clinical Global Impressions Severity Scale [Measured weekly throughout the study]

    Assesses functional status of individual

  6. Clinical Global Impressions Improvement Scale [Measured weekly throughout the study]

    Assesses improvement in functioning

  7. Sociodemographic Questionnaire [Measured at baseline]

    social and demographic characteristics of the individual

  8. Penn State Worry Questionnaire (PSWQ) [Measured 10 minutes, before, during, and after treatment]

    assesses worry and rumination

  9. Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR) [Measured 10 times throughout study]

    self-report measure of PTSD symptoms

  10. Brief Symptom Inventory (BSI) [Measured 10 times throughout study]

    assesses a wide range of symptoms regarding the distress they cause

  11. General Expectancy for Negative Mood Regulation (NMR) [Measured 3 times throughout study]

    assesses ability to regulate mood states

  12. State-Trait Anger Expression (STAXI) [Measured 10 times throughout study]

    assess experience of anger as both a state and trait like phenomenon

  13. Toronto Alexithymia Scale (TAS) [Measured 2 times throughout study]

    assesses difficulty in identifying and naming feelings

  14. The State-Trait Anxiety Inventory (STAI) [Measured 10 times throughout study]

    assesses types and severity of anxiety

  15. Beck Depression Inventory (BDI) [Measured 3 times throughout study]

    assesses type and severity of depression

  16. The Inventory of Interpersonal Problems (IIP) [Measured 2 times throughout study]

    assesses type and severity of interpersonal problems

  17. The Social Adjustment Scale - Self Report (SAS-SR) [Measured 2 times throughout study]

    assesses social adjustment

  18. fMRI Safety Information Checklist [Measured 2 times throughout study]

    review safety information related to fMRI procedure

  19. Medical History 12 Months (MH) [Measured throughout study]

    assessment of medical problems in past 12 months

  20. Health Services Utilization Form-12 Months (HSUF) [Measured throughout study]

    assessment of type and frequency of use of medical services

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
For people with PTSD:
  • Meets DSM-IV criteria for PTSD

  • Medically healthy

  • Right handed

  • Learned English prior to age 5

  • Agrees to use an effective form of contraception throughout the study

For healthy controls:
  • Medically healthy

  • Right handed

  • Has experienced a qualifying traumatic event

  • Does not meet DSM-IV criteria for present or past PTSD

  • Learned English prior to age 5

  • Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:
For people with PTSD:
  • Meets DSM-IV criteria for panic disorder within 6 months prior to study entry

  • Current suicide risk

  • History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar mood disorder, obsessive compulsive disorder (including trichotillomania), or eating disorder

  • Meets DSM-IV criteria for substance use or dependence within the 6 months prior to study entry

  • Any substance abuse within 2 weeks prior to study entry

  • Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) with depressive symptoms secondary to PTSD

  • Current participation in cognitive behavioral psychotherapy that is specifically designed to treat PTSD

  • Concomitant psychoactive medications

  • History of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems

  • Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS

  • Unstable general medical illness requiring intervention (e.g., HIV infection)

  • Pregnant, breastfeeding, or plans to become pregnant

  • Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins

  • History of gastric bypass surgery

For healthy controls:
  • Any history of generalized anxiety disorder or panic disorder

  • Any history of psychotic disorder, bipolar disorder, or cyclothymia

  • Any history of substance abuse or dependence within the 6 months prior to study entry

  • Any substance use within 2 weeks prior to study entry

  • Any other Axis I disorder within the year prior to study entry, including obsessive-compulsive disorder and trichotillomania

  • Unstable general medical illness requiring intervention (e.g., HIV infection)

  • Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins

  • Concomitant psychoactive medications

  • Patients with a history of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems

  • Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS

  • Cognitive impairment or severe Axis II disorder that will likely affect participation in the study

  • Pregnant, breastfeeding, or plans to become pregnant

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1NYU Institute for Trauma & ResilienceNew YorkNew YorkUnited States10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Marylene Cloitre, PhD, NYU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT00391430
Other Study ID Numbers:
  • P50MH058911
  • P50MH058911
  • DATR A3-NSC
First Posted:
Oct 24, 2006
Last Update Posted:
Jul 21, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by NYU Langone Health
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleSertralineControlCognitive Behavioral Therapy
Arm/Group DescriptionParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants assigned to the control condition will receive no treatmentParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Period Title: Overall Study
STARTED8031
COMPLETED5019
NOT COMPLETED3012

Baseline Characteristics

Arm/Group TitleControlSertralineCognitive Behavioral TherapyTotal
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.Total of all reporting groups
Overall Participants083139
Age (years) [Mean (Full Range) ]
Sex: Female, Male (Count of Participants)
Female
0
NaN
0
0%
0
0%
0
0%
Male
0
NaN
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleSalivary Cortisol Levels (Measured Before, During, and After the fMRI)
DescriptionSalivary cortisol levels (measured before, during, and after the fMRI)
Time FrameMeasured 3 days before and after treatment and 1 day during fMRI

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
2. Primary Outcome
TitleFear Response (Measured During the fMRI)
DescriptionFear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Time FrameMeasured on 1 day during two MRIs

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
3. Secondary Outcome
TitleTrauma History Inventory (THI)
DescriptionAssesses the full range of traumatic stressor over lifetime
Time FrameMeasured 30 minutes before and after treatment

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
4. Secondary Outcome
TitleClinician-Administered PTSD Scale for DSM-IV (CAPS)
DescriptionAssesses severity and frequency of PTSD symptoms and provides information for diagnosis
Time FrameMeasured 30 minutes before and after treatment

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
5. Secondary Outcome
TitleStructured Clinical Interview for DSM-IV I and II (SCID I and II)
DescriptionProvides assessment of all anxiety and mood disorder diagnoses
Time FrameMeasured 1 hour before and after treatment

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
6. Secondary Outcome
TitlePanic Disorder Severity Scale (PDSS)
Descriptionmeasure of frequency and severity of panic attacks
Time FrameMeasured 15 minutes before and after treatment

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
7. Secondary Outcome
TitleClinical Global Impressions Severity Scale
DescriptionAssesses functional status of individual
Time FrameMeasured weekly throughout the study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
8. Secondary Outcome
TitleClinical Global Impressions Improvement Scale
DescriptionAssesses improvement in functioning
Time FrameMeasured weekly throughout the study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
9. Secondary Outcome
TitleSociodemographic Questionnaire
Descriptionsocial and demographic characteristics of the individual
Time FrameMeasured at baseline

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
10. Secondary Outcome
TitlePenn State Worry Questionnaire (PSWQ)
Descriptionassesses worry and rumination
Time FrameMeasured 10 minutes, before, during, and after treatment

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
11. Secondary Outcome
TitlePost Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
Descriptionself-report measure of PTSD symptoms
Time FrameMeasured 10 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
12. Secondary Outcome
TitleBrief Symptom Inventory (BSI)
Descriptionassesses a wide range of symptoms regarding the distress they cause
Time FrameMeasured 10 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
13. Secondary Outcome
TitleGeneral Expectancy for Negative Mood Regulation (NMR)
Descriptionassesses ability to regulate mood states
Time FrameMeasured 3 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
14. Secondary Outcome
TitleState-Trait Anger Expression (STAXI)
Descriptionassess experience of anger as both a state and trait like phenomenon
Time FrameMeasured 10 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
15. Secondary Outcome
TitleToronto Alexithymia Scale (TAS)
Descriptionassesses difficulty in identifying and naming feelings
Time FrameMeasured 2 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
16. Secondary Outcome
TitleThe State-Trait Anxiety Inventory (STAI)
Descriptionassesses types and severity of anxiety
Time FrameMeasured 10 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
17. Secondary Outcome
TitleBeck Depression Inventory (BDI)
Descriptionassesses type and severity of depression
Time FrameMeasured 3 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
18. Secondary Outcome
TitleThe Inventory of Interpersonal Problems (IIP)
Descriptionassesses type and severity of interpersonal problems
Time FrameMeasured 2 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
19. Secondary Outcome
TitleThe Social Adjustment Scale - Self Report (SAS-SR)
Descriptionassesses social adjustment
Time FrameMeasured 2 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
20. Secondary Outcome
TitlefMRI Safety Information Checklist
Descriptionreview safety information related to fMRI procedure
Time FrameMeasured 2 times throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
21. Secondary Outcome
TitleMedical History 12 Months (MH)
Descriptionassessment of medical problems in past 12 months
Time FrameMeasured throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000
22. Secondary Outcome
TitleHealth Services Utilization Form-12 Months (HSUF)
Descriptionassessment of type and frequency of use of medical services
Time FrameMeasured throughout study

Outcome Measure Data

Analysis Population Description
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Arm/Group TitleControlSertralineCognitive Behavioral Therapy
Arm/Group DescriptionParticipants assigned to the control condition will receive no treatmentParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants000

Adverse Events

Time FrameUp to 4 years
Adverse Event Reporting Description 0 participants completed in control arm; therefore 0 participants at risk for adverse events
Arm/Group TitleSertralineControlCognitive Behavioral Therapy
Arm/Group DescriptionParticipants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeksParticipants assigned to the control condition will receive no treatmentParticipants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
All Cause Mortality
SertralineControlCognitive Behavioral Therapy
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/3 (0%) 0/0 (NaN) 0/12 (0%)
Serious Adverse Events
SertralineControlCognitive Behavioral Therapy
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/3 (0%) 0/0 (NaN) 0/12 (0%)
Other (Not Including Serious) Adverse Events
SertralineControlCognitive Behavioral Therapy
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/3 (0%) 0/0 (NaN) 0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

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

Name/TitleMarylene Cloitre
OrganizationNYU Langone
Phone2122632471
Emailmarylene.cloitre@nyulangone.org
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT00391430
Other Study ID Numbers:
  • P50MH058911
  • P50MH058911
  • DATR A3-NSC
First Posted:
Oct 24, 2006
Last Update Posted:
Jul 21, 2021
Last Verified:
Jun 1, 2021