Emotion Regulation Selection Flexibility Training for PTSD Patients
ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTel Aviv University
About this trial
This clinical study will examine the efficacy of a novel intervention aimed at improving Regulatory Selection Flexibility and PTSD symptoms among adult individuals with PTSD symptoms, compared to a tight active control group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
native Hebrew speakers
age between 18 - 65
normal or corrected to normal vision
computer and internet access
Disqualifiers
Complex PTSD
Psychotic disorders
substance dependence or abuse other than nicotine
Neurological condition
Trial design
Design model
Parallel
Treatments tested in this trial
Emotion Regulation Selection Flexibility Training
Behavioral7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on days without sessions. Psychoeducation includes information on selection of appropriate strategy according to the regulatory selection flexibility rule (i.e., distraction for high intensity vs reappraisal in low intensity). In the computerized task participants are exposed to emotional words and are asked to select a regulatory strategy in a flexible matter according to the regulatory selection flexibility rule, and receive feedback on whether they chose flexibly or not. Following , they are instructed to implement the chosen strategy. Homework includes choosing two daily events one of high intensity and a second one of low intensity, and describe which strategy they selected and how they implemented their chosen strategy according to the flexibility rule.
Emotion Regulation Active control Training
BehavioralAll the interventional sections are similar to the experimental group except that in the control group we omit the regulatory selection rule that defines which strategy is compatible with which emotional situation. 7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on the days without sessions. Psychoeducation explicitly included information on regulatory strategies (without the regulatory selection flexibility rule). In the computerized task participants are exposed to the same emotional words and are asked to choose freely a regulatory strategy (without the regulatory selection flexibility rule or feedback), and implement it. Homework includes choosing two daily events and selecting and implementing a regulatory strategy (without the regulatory selection flexibility rule).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Regulatory selection Flexibility TrainingExperimental treatment 1 intervention
Group B: Tight Active control TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pre to Post improvement of emotion regulatory selection flexibility
regulatory selection flexibility is calculated by subtracting adaptive choice from the maladaptive choice specifically by subtracting the proportion of distraction selection in the low intensity stimuli (maladaptive choice) from the proportion of distraction selection in the high intensity stimuli (adaptive choice).
Time frame
Measurements at Baseline and immidiately post treatment2
Change from baseline of the total score of the PTSD Checklist (PCL-5)
The PCL-5, is a 20-item PTSD Checklist for DSM-5. Scores can range from 0 to 80, with higher scores reflecting more PTSD symptoms.
Time frame
Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatmentOther outcomes
1
Change from baseline of the total score of the Sheehan Disabilities Scale (SDS)
A composite of three self-rated items measuring the extent to which three domains in participants lives are impaired. Each scale ranges between 0 ("not at all") to 10 ("very much"). The three items are averaged into a single dimensional measure of global functional impairment with scores ranging 0-10.
Time frame
Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment2
Change from baseline of the total score of the Beck Depression Inventory (BDI)
A composite score of the 20 items (omitted suicidally item) thus ranging from 0-60
Time frame
Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment3
Change from baseline of the total score of the Perceived Ability to Cope With Trauma (PACT) Scale
a 20-item self-report measure of one's beliefs about their capabilities in managing post-trauma sequelae. Two scale scores have been derived: trauma focus (perceived ability to process the trauma), and forward focus (perceived ability to move beyond the trauma). A flexibility score may also be derived, which represents an individual's ability to adaptively use both types of focus.
Time frame
Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatmentSponsors and contacts
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Source ClinicalTrials.gov