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Completed

NCT Number: NCT07732335

Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT) for Adolescents With PTSD Following Sexual Abuse

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.

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Key information

Conditions

Child Sexual Abuse Combat Disorders Mental Disorders Post-Traumatic Stress Disorder, PTSD Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Yenimahalle Training and Research Hospital

Ankara, 06370, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

II-TF-CBT

Behavioral

An inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for children and adolescents with post-traumatic stress disorder following sexual abuse. The protocol follows the standard TF-CBT components (psychoeducation, relaxation, affect regulation, cognitive coping, trauma narrative, in vivo mastery, conjoint sessions, and safety enhancement), delivered during inpatient hospitalization.

Primary outcomes

  1. 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

  1. Change in Children's Depression Inventory (CDI) Total Score

    Time frame: Baseline, Week 2, and Week 4

    The CDI is a self-report scale assessing the severity of depressive symptoms in children and adolescents. Change in CDI score reflects change in depressive symptom severity over the course of treatment. The Children's Depression Inventory (CDI) total score ranges from 0 to 54. Higher scores indicate more severe depressive symptoms (worse outcome).

  2. Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score

    Time frame: Baseline, Week 2, and Week 4

    The SCARED is a self-report scale assessing symptoms of anxiety disorders in children and adolescents. Change in SCARED score reflects change in anxiety symptom severity over the course of treatment. The Screen for Child Anxiety Related Emotional Disorders (SCARED) total score ranges from 0 to 82. Higher scores indicate more severe anxiety symptoms (worse outcome).

  3. Change in National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) Total Score

    Time frame: Baseline, Week 2, and Week 4

    The National Stressful Events Survey-PTSD Short Scale, Child Version (NSESSS), is a self-report scale assessing the severity of PTSD symptoms in children and adolescents following exposure to a traumatic event. Change in NSESSS score reflects change in PTSD symptom severity over the course of treatment. The National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) total score ranges from 0 to 36. Higher scores indicate more severe PTSD symptoms (worse outcome).

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Efficacy of Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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