- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07769996
Imagery Rescripting for Traumatic Panic Attack Memories
Investigation of Traumatic Components of Panic Attack Memories and Imagery Rescripting Intervention for Traumatic Panic Attack Memories
The current project consists of two studies investigating the phenomenological characteristics, centrality levels, and traumatic symptoms of panic attack memories, while testing the effectiveness of the Imagery Rescripting (ImRs) intervention in the treatment of panic disorder.
The first study investigates whether panic attack memories share similar phenomenological features, centrality levels, and physiological responses with classic traumatic memories and general negative life event memories in a sample of 152 participants.
The second study is a randomized controlled trial (RCT) involving 32 participants diagnosed with panic disorder based on DSM-5 criteria. Participants are randomly assigned to either an Imagery Rescripting (ImRs) intervention group or a control group. The primary objective is to evaluate the clinical effectiveness of a 6-session ImRs protocol in reducing panic disorder symptoms and physiological arousal associated with panic attack memories.
Přehled studie
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Bağcılar
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Istanbul, Bağcılar, Turecko (Türkiye)
- Bağcılar Eğitim ve Araştırma Hastanesi
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Being aged between 18 and 65 years. Voluntarily agreeing to participate in the study and providing informed consent.
Being fluent in written and spoken Turkish. Having a current diagnosis of Panic Disorder according to DSM-5 criteria, confirmed by a psychiatrist.
Answering "No" to the traumatic event screening question regarding the index panic memory (i.e., the panic memory does not involve exposure to actual or threatened death, serious injury, or physical threat).
Exclusion Criteria:
Being under 18 or over 65 years of age. Inability or unwillingness to provide informed consent. Insufficient Turkish literacy. Absence of a current psychiatric diagnosis of Panic Disorder according to DSM-5 criteria.
Having a lifetime diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria.
Answering "Yes" to the traumatic event screening question (i.e., presence of an explicit Criterion A traumatic event/physical threat in the index memory).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Imagery Rescripting Group
Participants in this arm receive a structured 6-session Imagery Rescripting (ImRs) protocol targeting traumatic panic attack memories.
The intervention incorporates psychoeducation regarding panic symptoms and autobiographical memory, breathing exercises, and imagery rescripting techniques aimed at modifying the traumatic components of panic memories and developing a healthy adult perspective.
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The protocol consists of a 6-session Imagery Rescripting (ImRs) intervention followed by a 1-month follow-up assessment.
Session 1 involves introduction, study orientation and baseline assessments (physiological recordings during memory writing and psychological scales).
Session 2 covers psychoeducation on panic disorder, breathing exercises, and the Safe Place exercise.
Session 3 introduces Healthy Adult Imagery to foster adaptive coping mechanisms.
Sessions 4 and 5 consist of core ImRs applications targeting traumatic panic attack memories and related early memories, utilizing therapist- or client-led adult interventions to fulfill unmet emotional needs.
Session 6 evaluates the intervention outcomes, future concerns and collects post-intervention measurements.
Session 7 serves as a 1-month follow-up evaluation with no active intervention.
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Žádný zásah: Control Group
Participants in this arm are assigned to the control group and do not receive the Imagery Rescripting intervention during the active study phase.
Assessment data (physiological measurements and psychological scales) are collected at parallel time points corresponding to the baseline, post-intervention, and 1-month follow-up of the intervention group.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from Baseline in DSM-5 Panic Disorder Symptom Severity at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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The DSM-5 Panic Disorder Scale (American Psychiatric Association, 2013; Turkish validation by Balıkçı et al., 2017) was used to measure the severity of panic disorder symptoms over the past 7 days.
The scale is a 10-item, single-factor measure.
The internal consistency coefficient (Cronbach's alpha) for the Turkish version was reported as .96.
Higher scores reflect greater severity of panic disorder symptoms.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in Physiological Reactivity (Heart Rate) During Panic Attack Memory Recall at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed by recording Heart Rate (beats per minute, BpM) an indicator of autonomic nervous system arousal during the panic attack memory writing/recall task.
Data are recorded using NeuLog Heart Rate & Pulse Logger Sensor (NUL-208) attached to the ring finger of the non-dominant hand.
Higher values of heart rate reflect greater autonomic arousal and physiological reactivity during traumatic memory recall.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in Physiological Reactivity (Skin Conductance Level) During Panic Attack Memory Recall at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed by recording Skin Conductance (microSiemens) as indicators of autonomic nervous system arousal during the panic attack memory writing/recall task.
Data are recorded using NeuLog NeuLog GSR Logger Sensor (NUL-217) attached to the index finger of the non-dominant hand.
Higher values of the skin conductance reflect greater autonomic arousal and physiological reactivity during traumatic memory recall.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from Baseline in Phenomenological Characteristics of Autobiographical Memory at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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To assess the phenomenological properties of autobiographical memories, the 63-item Autobiographical Memory Characteristics Questionnaire (Boyacıoğlu & Akfırat, 2015) was utilized.
The questionnaire comprises 8 subscales: narrative coherence, reliving, vividness, perceptual detail, field perspective, observer perspective, emotional valence, and emotional intensity.
Together, these subscales account for 72% of the total scale variance.
In the original validation study, the internal consistency coefficients (Cronbach's alpha) for the subscales ranged from .66 to .97.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in Event Centrality Score at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed using the 7-item short form of the Centrality of Event Scale (CES) (Berntsen & Rubin, 2006; Turkish adaptation by Boyacıoğlu & Aktaş, 2018) to measure the extent to which the traumatic panic memory is integrated into the participant's identity and life story (Cronbach alpha = .89
for negative memories).
Items are rated on a 5-point Likert scale, with total scores ranging from 7 to 35.
Higher scores reflect greater event centrality.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in Traumatic Stress Symptom Severity at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed using the 22-item Turkish version of the Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997; Turkish adaptation by Çorapçıoğlu et al., 2006) to evaluate traumatic stress symptoms associated with panic memories over the past week.
The scale consists of 3 subscales: Intrusion, Avoidance, and Hyperarousal.
Internal consistency values range from .88 to .94.
Total scores range from 0 to 88, with higher scores indicating greater severity of post-traumatic stress symptoms.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in General Self-Efficacy Score at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed using the 17-item Turkish version of the General Self-Efficacy Scale (Sherer et al., 1982; Turkish adaptation by Yıldırım & Özgür İlhan, 2010) to evaluate individuals' belief in their ability to cope with challenging life events.
The scale demonstrates a three-factor structure accounting for 41.47% of the total variance, with an internal consistency coefficient of Cronbach alpha = .80.
Higher scores indicate higher levels of perceived general self-efficacy.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Change from Baseline in Perceived Panic Self-Efficacy Score at Post-Intervention and 1-Month Follow-Up
Časové okno: Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Assessed using a single-item question rated on a 6-point Likert scale (ranging from 0 = "Not confident at all" to 5 = "Completely confident"), adapted based on the work by Helbig-Lang (2012).
The item asks: "How confident do you feel in your ability to cope with a potential panic attack in the future?"
Higher scores reflect greater perceived self-efficacy in managing future panic attacks.
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Baseline, 6 weeks (post-treatment, following six weekly 50-minute sessions), and 1-month post-treatment follow-up
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 224K508 (Jiné číslo grantu/financování: TÜBİTAK 1002-A Project)
- 26.12.2023 10/12 (Jiný identifikátor: Ethics Committee Approval No)
- 23.05.2024 2024/09 (Jiný identifikátor: Turkish Ministry of Health)
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