Pharmacologic Treatment of PTSD in Sexually Abused Children

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Other)
• Overall Status: Completed
• CT.gov ID: NCT00078767
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: Trauma-Focused Cognitive Behavioral Therapy; Drug: Sertraline Pill; Drug: Placebo Oral Tablet	Phase 3

Detailed Description

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacologic Treatment of PTSD in Sexually Abused Children
• Study Start Date: Apr 1, 2001
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TF-CBT + sertraline Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day	Behavioral: Trauma-Focused Cognitive Behavioral Therapy; 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent; Drug: Sertraline Pill; 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Active Comparator: TF-CBT +placebo Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)	Drug: Sertraline Pill; 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT; Drug: Placebo Oral Tablet; 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Outcome Measures

Primary Outcome Measures

1. Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD [Up to 39 months]

   Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.

Secondary Outcome Measures

1. Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms [Up to 39 months]

   Change in depressive symptoms as determined by change in score

2. Anxiety Symptoms [Up to 39 months]

   Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.

3. Global Impairment [Up to 39 months]

   Change in Children's Global Assessment Scale (CGAS) between the two groups

4. Incidence of Suicidality [Up to 39 months]

   Change in degree of suicidal ideation during study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion:

1. Ages 10-17 years, inclusive

2. Confirmed sexual abuse

3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)

4. Parent/primary caregiver available to participate in treatment

5. Assent with parental consent to participate

Exclusion:

1. Non-English speaking

2. schizophrenia or other severe psychotic disorder

3. MR (IQ<60) or PDD preventing CBT treatment

4. taking current psychotropic medication

5. documented substance dependence (substance abuse allowed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Judith A Cohen, M.D., Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• National Child Traumatic Stress Network

Publications

• Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9.

• Responsible Party: Judith Cohen, Principle Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• ClinicalTrials.gov Identifier: NCT00078767
• Other Study ID Numbers: K02MH001938; K02MH001938
• First Posted: Mar 8, 2004
• Last Update Posted: Apr 5, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Judith Cohen, Principle Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): PTSD; Depression; Anxiety
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic; Sertraline

Study Results

Participant Flow

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Period Title: Overall Study
STARTED	12	12
COMPLETED	11	11
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo	Total
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT	Total of all reporting groups
Overall Participants	11	11	22
Age (Count of Participants)
<=18 years	11 100%	11 100%	22 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	14	14	14
Sex: Female, Male (Count of Participants)
Female	11 100%	11 100%	22 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	6 54.5%	6 54.5%	12 54.5%
African American	5 45.5%	5 45.5%	10 45.5%
Region of Enrollment (participants) [Number]
United States	11 100%	11 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
Description	Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.
Time Frame	Up to 39 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Measure Participants	11	11
PTSD diagnosis at enrollment but no PTSD at end	8 72.7%	6 54.5%
PTSD at enrollment and PTSD at end	1 9.1%	5 45.5%
No PTSD diagnosis at enrollment and no PTSD at end	2 18.2%	0 0%

2. Secondary Outcome

Title	Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Description	Change in depressive symptoms as determined by change in score
Time Frame	Up to 39 months

Outcome Measure Data

Analysis Population Description

There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Measure Participants	11	11
Clinical symptoms CS at enrollment to no CS at end	8 72.7%	5 45.5%
No clinical symptoms at enrollment; no CS at end	3 27.3%	6 54.5%

3. Secondary Outcome

Title	Anxiety Symptoms
Description	Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.
Time Frame	Up to 39 months

Outcome Measure Data

Analysis Population Description

There were two categories of anxiety symptoms: participants that had clinical signs of anxiety at the time of enrollment as evidenced by their SCARED scores, and participants that did not have clinical signs of depression. Participants with clinical symptoms category were tested to see if their status changed during the trial.

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Measure Participants	11	11
Cinical at start to nonclinical at end of trial	8 72.7%	5 45.5%
Nonclinical at start of trial	2 18.2%	2 18.2%
Clinical at start and remained clinical	1 9.1%	4 36.4%

4. Secondary Outcome

Title	Global Impairment
Description	Change in Children's Global Assessment Scale (CGAS) between the two groups
Time Frame	Up to 39 months

Outcome Measure Data

Analysis Population Description

There were two categories of depression: participants that had clinical signs of impairment at the time of enrollment as evidenced by their CGAS scores, and participants that did not have clinical signs of depression. Participants clinical symptoms were tested to see if their status changed during the trial.

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Measure Participants	11	11
Clearly impaired to not clearly impaired	9 81.8%	6 54.5%
Remained clearly impaired	2 18.2%	5 45.5%

5. Secondary Outcome

Title	Incidence of Suicidality
Description	Change in degree of suicidal ideation during study
Time Frame	Up to 39 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT + Sertraline	TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Measure Participants	11	11
Suicigal ideation at start of trial	4 36.4%	1 9.1%
Suicidal ideation at end of trial	0 0%	0 0%
No suicidal ideation at start or end of trial	7 63.6%	10 90.9%

Adverse Events

Time Frame	39 months
Arm/Group Title	TF-CBT + Sertraline		TF-CBT +Placebo
Arm/Group Description	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT		Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
All Cause Mortality
	TF-CBT + Sertraline		TF-CBT +Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	TF-CBT + Sertraline		TF-CBT +Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	TF-CBT + Sertraline		TF-CBT +Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.