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)
• Enrollment: 39
• Location: 1
• Arms: 3
• Duration (Months): 50
• Patients Per Site Per Month: 0.8

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 Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Drug: Sertraline; Behavioral: Cognitive behavioral therapy (CBT)	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	NYU Institute for Trauma & Resilience	New York	New York	United States	10016

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: PTSD; Trauma; Sexual Abuse; Sexual Assault
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Sertraline

Study Results

Participant Flow

Arm/Group Title	Sertraline	Control	Cognitive Behavioral Therapy
Arm/Group Description	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants assigned to the control condition will receive no treatment	Participants 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
STARTED	8	0	31
COMPLETED	5	0	19
NOT COMPLETED	3	0	12

Baseline Characteristics

Arm/Group Title	Control	Sertraline	Cognitive Behavioral Therapy	Total
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants 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 Participants	0	8	31	39
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

Title	Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Description	Salivary cortisol levels (measured before, during, and after the fMRI)
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

2. Primary Outcome

Title	Fear Response (Measured During the fMRI)
Description	Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

3. Secondary Outcome

Title	Trauma History Inventory (THI)
Description	Assesses the full range of traumatic stressor over lifetime
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

4. Secondary Outcome

Title	Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Description	Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Description	Provides assessment of all anxiety and mood disorder diagnoses
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Panic Disorder Severity Scale (PDSS)
Description	measure of frequency and severity of panic attacks
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

7. Secondary Outcome

Title	Clinical Global Impressions Severity Scale
Description	Assesses functional status of individual
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

8. Secondary Outcome

Title	Clinical Global Impressions Improvement Scale
Description	Assesses improvement in functioning
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

9. Secondary Outcome

Title	Sociodemographic Questionnaire
Description	social and demographic characteristics of the individual
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

10. Secondary Outcome

Title	Penn State Worry Questionnaire (PSWQ)
Description	assesses worry and rumination
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

11. Secondary Outcome

Title	Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
Description	self-report measure of PTSD symptoms
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

12. Secondary Outcome

Title	Brief Symptom Inventory (BSI)
Description	assesses a wide range of symptoms regarding the distress they cause
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

13. Secondary Outcome

Title	General Expectancy for Negative Mood Regulation (NMR)
Description	assesses ability to regulate mood states
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

14. Secondary Outcome

Title	State-Trait Anger Expression (STAXI)
Description	assess experience of anger as both a state and trait like phenomenon
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

15. Secondary Outcome

Title	Toronto Alexithymia Scale (TAS)
Description	assesses difficulty in identifying and naming feelings
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

16. Secondary Outcome

Title	The State-Trait Anxiety Inventory (STAI)
Description	assesses types and severity of anxiety
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

17. Secondary Outcome

Title	Beck Depression Inventory (BDI)
Description	assesses type and severity of depression
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

18. Secondary Outcome

Title	The Inventory of Interpersonal Problems (IIP)
Description	assesses type and severity of interpersonal problems
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

19. Secondary Outcome

Title	The Social Adjustment Scale - Self Report (SAS-SR)
Description	assesses social adjustment
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

20. Secondary Outcome

Title	fMRI Safety Information Checklist
Description	review safety information related to fMRI procedure
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

21. Secondary Outcome

Title	Medical History 12 Months (MH)
Description	assessment of medical problems in past 12 months
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

22. Secondary Outcome

Title	Health Services Utilization Form-12 Months (HSUF)
Description	assessment of type and frequency of use of medical services
Time Frame	Measured 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 Title	Control	Sertraline	Cognitive Behavioral Therapy
Arm/Group Description	Participants assigned to the control condition will receive no treatment	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks	Participants will receive cognitive behavioral therapy Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Measure Participants	0	0	0

Adverse Events

Time Frame	Up to 4 years
Adverse Event Reporting Description	0 participants completed in control arm; therefore 0 participants at risk for adverse events
Arm/Group Title	Sertraline		Control		Cognitive Behavioral Therapy
Arm/Group Description	Participants will receive treatment with sertraline Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks		Participants assigned to the control condition will receive no treatment		Participants 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
	Sertraline		Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)		0/12 (0%)
Serious Adverse Events
	Sertraline		Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Sertraline		Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (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.