Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD, Depression, Anxiety
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).
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.
Interventions
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
DRUGSertraline Pill
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
DRUGPlacebo Oral Tablet
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Sponsors
National Institute of Mental Health (NIMH)
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | Up to 39 months | Change in depressive symptoms as determined by change in score |
| 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. |
| Global Impairment | Up to 39 months | Change in Children's Global Assessment Scale (CGAS) between the two groups |
| Incidence of Suicidality | Up to 39 months | Change in degree of suicidal ideation during study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 11 |
| 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)
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 | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | TF-CBT + Sertraline | TF-CBT +Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14 years | 14 years | 14 years |
| Race/Ethnicity, Customized African American | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TF-CBT + Sertraline | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | PTSD diagnosis at enrollment but no PTSD at end | 8 Participants |
| TF-CBT + Sertraline | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | PTSD at enrollment and PTSD at end | 1 Participants |
| TF-CBT + Sertraline | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | No PTSD diagnosis at enrollment and no PTSD at end | 2 Participants |
| TF-CBT +Placebo | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | PTSD diagnosis at enrollment but no PTSD at end | 6 Participants |
| TF-CBT +Placebo | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | PTSD at enrollment and PTSD at end | 5 Participants |
| TF-CBT +Placebo | Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | No PTSD diagnosis at enrollment and no PTSD at end | 0 Participants |
Secondary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TF-CBT + Sertraline | Anxiety Symptoms | Cinical at start to nonclinical at end of trial | 8 Participants |
| TF-CBT + Sertraline | Anxiety Symptoms | Nonclinical at start of trial | 2 Participants |
| TF-CBT + Sertraline | Anxiety Symptoms | Clinical at start and remained clinical | 1 Participants |
| TF-CBT +Placebo | Anxiety Symptoms | Cinical at start to nonclinical at end of trial | 5 Participants |
| TF-CBT +Placebo | Anxiety Symptoms | Nonclinical at start of trial | 2 Participants |
| TF-CBT +Placebo | Anxiety Symptoms | Clinical at start and remained clinical | 4 Participants |
Secondary
Global Impairment
Change in Children's Global Assessment Scale (CGAS) between the two groups
Time frame: Up to 39 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TF-CBT + Sertraline | Global Impairment | Clearly impaired to not clearly impaired | 9 Participants |
| TF-CBT + Sertraline | Global Impairment | Remained clearly impaired | 2 Participants |
| TF-CBT +Placebo | Global Impairment | Clearly impaired to not clearly impaired | 6 Participants |
| TF-CBT +Placebo | Global Impairment | Remained clearly impaired | 5 Participants |
Secondary
Incidence of Suicidality
Change in degree of suicidal ideation during study
Time frame: Up to 39 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TF-CBT + Sertraline | Incidence of Suicidality | Suicidal ideation at end of trial | 0 Participants |
| TF-CBT + Sertraline | Incidence of Suicidality | No suicidal ideation at start or end of trial | 7 Participants |
| TF-CBT + Sertraline | Incidence of Suicidality | Suicigal ideation at start of trial | 4 Participants |
| TF-CBT +Placebo | Incidence of Suicidality | Suicigal ideation at start of trial | 1 Participants |
| TF-CBT +Placebo | Incidence of Suicidality | Suicidal ideation at end of trial | 0 Participants |
| TF-CBT +Placebo | Incidence of Suicidality | No suicidal ideation at start or end of trial | 10 Participants |
Secondary
Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Change in depressive symptoms as determined by change in score
Time frame: Up to 39 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TF-CBT + Sertraline | Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | Clinical symptoms CS at enrollment to no CS at end | 8 Participants |
| TF-CBT + Sertraline | Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | No clinical symptoms at enrollment; no CS at end | 3 Participants |
| TF-CBT +Placebo | Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | Clinical symptoms CS at enrollment to no CS at end | 5 Participants |
| TF-CBT +Placebo | Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | No clinical symptoms at enrollment; no CS at end | 6 Participants |