Jishishan County Resettlement Middle School
Linxia, Gansu, 731700, China
NCT Number: NCT06403449
The study aims to examine the effectiveness of group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD in Chinese adolescents through a randomized controlled trial. A total of 50 participants will be recruited, with 25 randomized to the GWE group and 25 to the waiting-list (WL) group. The GWE intervention will consist of 5 to 8 group sessions. The primary outcome, PTSD and CPTSD symptom severity, will be assessed at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Linxia, Gansu, 731700, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group-Delivered guided written exposure therapy (GWE) is a manualized exposure-based therapy program consisting of 5-8 sequential sessions. The interval between every 2 consecutive sessions is 0-2 days. There will be 5-8 group-delivered sessions in total (only one index trauma will be discussed), and 1-2 weeks to complete.The first and last sessions are scheduled to last for 1.5 hours each, while the other sessions will be 50 minutes in duration.
Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the waitting period. After the one-month follow-up of the GWE group, they will receive the same treatment.WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.
Time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
PCL-5 was a 20-item self-report scale that assesses PTSD DSM-5 diagnosis and symptom severity in the past month. Items were rated on a 5-point Likert scale from 0 ("not at all") to 4("extremely").The Chinese version of PCL-5 has shown good psychometric properties in trauma-affected Chinese adolescents.
Time frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
CPTSD symptoms include two parts: PTSD symptoms were assessed using six PCL-5 items mapped to ICD-11 domains: re-experiencing (items 2 and 3), avoidance (items 6 and 7), and sense of current threat (items 17 and 18). Disturbances in self-organization (DSO) were measured using the 6-item DSO subscale of the International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA), which has demonstrated good validity in Chinese adolescent samples. The resulting 12-item composite yielded total scores ranging from 0 to 48, consistent with ITQ-CA scoring conventions.
Time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Patient Health Questionnaire 9-item (PHQ-9), a self-report measure for depressive symptoms in past two weeks, comprises 9 items rated from 0 (not at all) to 3 (nearly every day). The PHQ-9 has good psychometric properties in Chinese adolescents.
Time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7- item self-report measure assess anxiety symptoms in past two weeks. Each item is rated from 0 (not at all) to 3 (nearly every day).The Chinese version GAD-7 score has good psychometric properties among adolescents.
Time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report questionnaire assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour .The response scale ranges from 0 ( not true) to 2 (certainly true). Chinese version has been demonstrated to have good internal consistency.
Peking University
Other
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial
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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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