The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPeking University
About this trial
This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 10 and 18 years;
Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as missing at most one symptom from either the PTSD or DSO clusters;
Possess sufficient literacy and language skills to complete writing-based tasks;
Be able to understand the study procedures and complete the required assessments;
Disqualifiers
Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
Presence of a severe physical illness that would impair the ability to engage in the intervention;
Assessed as being at high suicidal risk (e.g., current suicidal ideation with intent or plan, recent suicide attempt within the past 12 months, or severe self-harm behaviors);
Ongoing exposure to traumatic events;
Trial design
Design model
Parallel
Treatments tested in this trial
Group Guided Written Exposure Therapy for CPTSD (GWE-C)
BehavioralGroup Guided Written Exposure Therapy for CPTSD (GWE-C) is a manualized, exposure-based therapeutic program consisting of 7 to 10 sequential sessions. The intervention follows a structured sequence of trauma processing that addresses trauma details, associated emotions, cognitions, and impacts. Writing tasks incorporate imagery dialogues, self-compassion exercises, and resource identification to help participants alleviate C-PTSD symptoms. The interval between two consecutive sessions ranges from 0 to 2 days, with participants expected to complete all sessions within 1 to 2 weeks. The first and last sessions are scheduled to last 1.5 hours each, while the intermediate sessions are 60 minutes in duration. Each group will consist of 6 to 10 participants and will be facilitated by one counselor and one assistant.
Supportive Group
BehavioralSupportive group, the comparator intervention, is a non-trauma-focused treatment based on the Rogerian psychotherapy model and has been used as an active comparator in previous trials of trauma-focused therapies. The program comprises seven sessions: the first two employ group activities such as card games and interactive drawing to build a sense of belonging; sessions three to six focus on stress management and emotion regulation skills through methods including expressive drawing, relaxation training, and resource identification; the final session emphasizes reflection and sharing. Throughout, counsellors provide supportive guidance to encourage emotional expression, mutual listening, and peer support, while discussions deliberately exclude participants' individual traumatic experiences.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: GWE-CExperimental treatment 1 intervention
Group B: Supportive groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
CPTSD Symptom Severity (self-report)
International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA ) is a self-report measure that assesses ICD-11 PTSD and CPTSD. The measure includes 6 core items of PTSD symptom clusters (ie. re-experiencing, avoidance, sense of threat), 6 core items of Disturbances in Self-Organization (DSO) clusters (ie affective dysregulation, negative self-concept, disturbed relationships). Each item is rated from 0(not at all) to 4(extremely). The Chinese version has been demonstrated good psychometric properties (Ho et al., 2022).
Time frame
baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)2
CPTSD Symptom Severity (interview)
The Child CPTSD Symptom Interview (CCSI) is a 12-item semi-structured interview developed by adapting items from the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I) and the International Trauma Interview (ITI).The PTSD section of the CCSI includes two items for each of the three PTSD symptom clusters, following the structure of the CPSS-5-I: re-experiencing (Re), characterized by flashbacks or nightmares; avoidance (Av), referring to avoidance of internal or external reminders of the traumatic event; and a sense of current threat (Th), expressed through hypervigilance or exaggerated startle reactions.The second part assesses Disturbances in Self-Organization (DSO) symptoms, based on the structure of the ITI , with two items per DSO symptom cluster.
Time frame
baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)Secondary outcomes
1
PTSD Checklist-5 (PCL-5)
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)2
Patient Health Questionnaire 9-item
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)3
Generalized Anxiety Disorder 7-item
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)4
The Strengths and Difficulties Questionnaire
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.
Time frame
baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)Sponsors and contacts
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Source ClinicalTrials.gov