The Efficacy of Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in Clinical Global Impression-Severity (CGI-S) Score
Study Overview
Brief Summary
This study looks at a treatment program for children and teens who have post-traumatic stress disorder (PTSD) after sexual abuse. The program is called II-TF-CBT. It is a special version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a type of cognitive behavioral therapy that helps people process trauma. II-TF-CBT is used with patients who stay in the hospital during treatment.
Researchers want to know if II-TF-CBT helps young patients recover as well as, or better than, standard outpatient treatment. Outpatient treatment means patients visit the clinic but do not stay overnight.
The study compares two groups. One group of 42 patients received II-TF-CBT during a hospital stay. The other group of 33 patients received standard outpatient treatment. Patients needing inpatient care were placed on an admission waiting list and admitted as their turn came; the remaining patients continued outpatient follow-up. Group placement therefore happened naturally, without researcher intervention.
Doctors measured each patient's PTSD symptoms and related problems before treatment, after treatment, and at a follow-up visit. This will help show whether inpatient TF-CBT-based care can help children and teens recover from trauma.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 11-17 years.
- •Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria following sexual abuse.
- •Admitted for inpatient treatment in the hospital's child and adolescent psychiatry inpatient unit within the 18-month enrollment period (II-TF-CBT group), or placed on the inpatient admission waiting list and followed in the outpatient clinic during the same period (outpatient control group).
- •Patients meeting all eligibility criteria during the enrollment period were included.
- •Assignment to the inpatient or outpatient control group was determined by clinical prioritization and admission order rather than by investigators.
Exclusion Criteria
- •Age younger than 11 years or older than 17 years.
- •Refusal to participate in the study.
- •Schizophrenia or another active psychotic disorder.
- •Current manic episode.
- •Intellectual disability.
- •Pervasive developmental disorder.
Arms & Interventions
II-TF-CBT (Inpatient)
Patients hospitalized for treatment who received the II-TF-CBT protocol - an inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) that includes an added Intake phase prior to the standard TF-CBT components. Patients were admitted from a waiting list of children and adolescents requiring inpatient care for post-traumatic stress disorder (PTSD) following sexual abuse. Group assignment occurred naturally based on bed availability and admission order, not by researcher allocation. N=42.
Intervention: II-TF-CBT (Behavioral)
Outpatient Follow-up (Control)
Patients who continued standard outpatient treatment for PTSD following sexual abuse, without hospitalization. These patients remained on outpatient follow-up because they did not require or were not admitted for inpatient care. Group assignment occurred naturally based on clinical need, not by researcher allocation. N=33.
Outcomes
Primary Outcomes
Change in Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Baseline, Week 2, and Week 4)
The CGI-S is a clinician-rated scale assessing the overall severity of the patient's psychiatric symptoms on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Change in CGI-S score over the course of treatment reflects overall clinical improvement in trauma-related symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater illness severity (worse outcome).
Secondary Outcomes
- Change in Children's Depression Inventory (CDI) Score(Baseline, Week 2, and Week 4)
- Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Score(Baseline, Week 2, and Week 4)
- Change in National Stressful Events Survey-PTSD Short Scale (Child Version) Score(Baseline, Week 2, and Week 4)
- Change in Children's Depression Inventory (CDI) Total Score(Baseline, Week 2, and Week 4)
- Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score(Baseline, Week 2, and Week 4)
- Change in National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) Total Score(Baseline, Week 2, and Week 4)
Investigators
sevda dabak
Resident Physician, Child and Adolescent Psychiatry
Ankara City Hospital Bilkent