A Phase 3 interventional study of Trauma-Focused Cognitive Behavioral Therapy and Sertraline Pill in Stress Disorders, Post-Traumatic, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Phase 3, Interventional, and Treatment
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).
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 42 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
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 · Drug: Sertraline Pill
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 · Drug: Placebo Oral Tablet
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
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
Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Change in depressive symptoms as determined by change in score
Time frame: Up to 39 months
Anxiety Symptoms
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
Global Impairment
Change in Children's Global Assessment Scale (CGAS) between the two groups
Time frame: Up to 39 months
Incidence of Suicidality
Change in degree of suicidal ideation during study
Time frame: Up to 39 months
| Milestone | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| Started | 12 | 12 |
| Completed | 11 | 11 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Participants | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| PTSD diagnosis at enrollment but no PTSD at end | 8 | 6 |
| PTSD at enrollment and PTSD at end | 1 | 5 |
| No PTSD diagnosis at enrollment and no PTSD at end | 2 | 0 |
Change in depressive symptoms as determined by change in score
| Participants | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| Clinical symptoms CS at enrollment to no CS at end | 8 | 5 |
| No clinical symptoms at enrollment; no CS at end | 3 | 6 |
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.
| Participants | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| Cinical at start to nonclinical at end of trial | 8 | 5 |
| Nonclinical at start of trial | 2 | 2 |
| Clinical at start and remained clinical | 1 | 4 |
Change in Children's Global Assessment Scale (CGAS) between the two groups
| Participants | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| Clearly impaired to not clearly impaired | 9 | 6 |
| Remained clearly impaired | 2 | 5 |
Change in degree of suicidal ideation during study
| Participants | TF-CBT + Sertraline | TF-CBT +Placebo |
|---|---|---|
| Suicigal ideation at start of trial | 4 | 1 |
| Suicidal ideation at end of trial | 0 | 0 |
| No suicidal ideation at start or end of trial | 7 | 10 |
Collected over 39 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TF-CBT + Sertraline | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| TF-CBT +Placebo | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| <=18 years | 11 | 11 | 22 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| Mean | 14 (10 to 17) | 14 (10 to 17) | 14 (10 to 17) |
| Sex: Female, Male(Participants) | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| White | 6 | 6 | 12 |
| African American | 5 | 5 | 10 |
| Region of Enrollment(participants) | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)