Optimizing inhibitory learning will enhance treatment efficacy for PTSD.
ID
Bron
Verkorte titel
Aandoening
Posttraumatic stress disorder
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main outcome will be change from baseline to one week follow-up in subjective fear (i.e. Subjective Units of Distress; SUDs) and physiological fear responses (i.e. heart rate and skin conductance) during a trauma imagery procedure.
Achtergrond van het onderzoek
Posttraumatic stress disorder (PTSD) is a disruptive disorder, with a large psychological, social and economic impact. Exposure therapy is a first-line treatment for PTSD. Although it has proven to be an effective treatment for PTSD, fifty percent of people remain symptomatic after treatment. Extinction learning is thought to be the most important mechanism of action of exposure therapy. Extinction is based on the learning non-threat inhibitory associations. Pre-clinical studies have established strategies to enhance inhibitory learning and thereby improve treatment effects. These strategies are summarized within Inhibitory Learning Theory (ILT). This current project examines ILT-based strategies and techniques to improve exposure treatment outcome in PTSD.
The project comprises three separate randomized controlled trials (RCTs), with identical study designs and consecutive participant enrolment. Per study, patients suffering from PTSD will randomly allocated to standard exposure or ILT-enhanced exposure. ILT enhancement strategies include maximizing expectancy violation, increasing fear and stimulus variability and increasing context variability.
Doel van het onderzoek
Optimizing inhibitory learning will enhance treatment efficacy for PTSD.
Onderzoeksopzet
Data will be collected prior to the exposure session (T1), during the exposure session (T2), one week after the exposure session (T3) and at 3-month follow-up (T4).
Onderzoeksproduct en/of interventie
Irrespective of group allocation, participants will receive one 90-minute exposure session. The control group will receive ‘standard exposure’, that is, exposure as it is currently delivered in routine clinical practice. The experimental group will receive ILT-enhanced exposure, such as 1) maximizing expectancy violation, 2) increasing fear and stimulus variability and 3) increasing context variability.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
• Diagnosed with current PTSD and satisfying DSM-5 defined criteria for Post-Traumatic
Stress Disorder as established by SCID-5-SV interview
• Self-reported PTSD symptoms above clinical cut-off (i.e. PCL-5 score > 31)
• Index trauma is related to physical or sexual violence
• One specific memory related to the index trauma
• Age between 18 and 70 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential participant who meets any of the following criteria will be excluded from participation in this study:
• Current trauma-focused treatment (e.g. exposure; EMDR)
• Patients with significant suicidal ideations/serious self-injurious behaviour or who have enacted suicidal behaviours or serious self-injurious behaviour within 3 months prior to intake will be excluded from participation
• Mental retardation
• Substance or alcohol dependence
• Somatic illness that interfere with exposure interventions or planned assessments (e.g. cardiac conditions)
• Pregnancy
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL8864 |
CCMO | NL73480.058.20 |
OMON | NL-OMON54936 |