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ID
Source
Brief title
Health condition
Posttraumatic stress disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the difference scores on the two VAS scales that are determined at the beginning (pre-measurement) and the end post measurement) of each intervention block. These blocks takes four minutes. Each patient is exposed to the three different conditions (P, N,O). Total of 12 minutes.The patients are exposed to the three conditions two times. Total duration of intervention is 24 minutes.We also have measurements between the blocks. These difference scores within and between the blocks will be tested per variable, brightness/living condition and emotionality/unpleasantness with three-way.
Secondary outcome
We expect that patients with a relative greater working memory will benefit more from the treatment compared to patients with less working memory capacity when the impact of the trauma is high.We also expect that patients with a relative limited working memory capacity will benefit when the impact of the trauma is light.
Afterwards we investigate whether the relationship between the experienced impact of the traumatic memory and the capacity of the working memory is different in the positive condition compared to the neutral condition. We also investigate whether the amount of self-esteem is a predictor of the effectiveness of dual tasking in both treatment conditions.
Background summary
This study with patients with PTSD primarily seeks to examine working mechanisms of dual tasking by investigating whether the emotional valence of the distractor or the working memory load is of importance. The primary hypotheses is that a positive task will be more effective in distracting compared to distraction with a neutral or an exposure only task. We also assume that patients with a relative greater working memory will benefit more from the treatment compared to patients with less working memory capacity when the impact of the trauma is high. We expect that patients with a relative limited working memory capacity will benefit more when the impact of the trauma is light. This hypothesis is based on the so-called inverted U model (Van den Hout, & Engelhard, 2012). Possibly there exists an optimised interaction between maximum load, working memory capacity and the experienced impact of the traumatic experience. To ultimately optimize trauma treatment, research into these aspects is warranted.
Study objective
Primary hypothesis is whether patients with a PTSD the distraction of a positive emotional valence will be more effective in decreasing the vividness and emotionality of a traumatic memory compared to distraction with a neutral task or exposure only condition.
Study design
We suppose to end our study when we have included thirty patients. We expect to end the inclusion of patients in November of 2020
Intervention
In this study we use a cross over design. Patients are exposed to three different conditions namely distraction with a positieve (P), neutral (N) or exposure only (O) condition. The draw for all six possible orders is masked and balanced and takes place by an independent researcher after inclusion.
Inclusion criteria
In order to be eligible to participate in this study a subject must meet all of the following inclusion criteria: (1) Patients have a posttraumatic stress disorder, according DSM-5 criteria. This is determined by the Dutch translation of the PTSD diagnostic Scale for DSM-5 (PDS-5) (Foa, 2013). (2) Patients are indicated for a treatment with EMDR or TF cognitive therapy and (3) the treatment is at the point of beginning or has begun until a maximum of three months and (4) the patients has not been treated for these the current complaints with TF cognitive therapy or EMDR in the last two years. (5) Age between 18 and 65 years old (6) being able to understand and speak Dutch (7) A stable use of psychotropic medication (8) informed consent to participate in the study.
Exclusion criteria
Patients were excluded when they suffered from severe emotional or psychosocial problems defined as: acute crisis, suicidality, psychosis or addiction to alcohol or drugs.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8384 |
| Other | Ethical board of the Leiden University medical centre, : This study received ethical board approval :P15.072 |