The primary aim of this study is to study the effectiveness of online CT+EMDR (vs. waitlist controls), in terms of reduction in PTSD and depression symptom-levels, for people who have been involved in a traffic accident. We expect that people…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are symptom-levels of PTSD and depression.
PTSD: PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013)
Depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Secondary outcome
Secondary outcomes are rumination, self-efficacy, and the acceptibility of
online treatment.
Rumination: Ruminative Response Scale (RRS; Treynor et al., 2003)
Self-efficacy: General Self-efficacy Scale (GSES; Schwarzer et al., 1995)
The acceptability of online treatment will be measured using two open-ended
qualitative questions (i.e., *which aspects of the treatment were you satisfied
with?*, *which aspects of the treatment were you dissatisfied with?*)
Background summary
Eye movement desensitization and reprocessing (EMDR) combined with cognitive
therapy (CT) is a treatment of choice for post-traumatic stress disorder
(PTSD). In the current Covid-19 pandemic, many therapies have necessarily
switched to an online format. Promisingly, studies investigating online
cognitive therapy (CT) indicate the positive effects of this treatment for PTSD
and depression. However, to data only one (uncontrolled) study has been
conducted to assess the effects of online EMDR. This means that the scientific
basis for online EMDR for PTSD is currently lacking. As online EMDR is already
being used by many therapists within the Netherlands, it is important to
investigate what the effects of online EMDR treatment for PTSD are. Therefore,
we aim to investigate whether online EMDR is an effective therapy that should
be used in clinical practice.
Study objective
The primary aim of this study is to study the effectiveness of online CT+EMDR
(vs. waitlist controls), in terms of reduction in PTSD and depression
symptom-levels, for people who have been involved in a traffic accident. We
expect that people allocated to a condition with online EMDR+CT will show lower
PTSD and depression symptom-levels post-treatment than people allocated to a
waitlist, while taking baseline symptom-levels into account.
Study design
A two-arm (online EMDR+CT vs. waitlist followed by online CT) open label
parallel randomized controlled trial will be conducted. Self-report measures
will be completed by participants at pre-treatment and post-treatment.
Intervention
This investigational treatment is an online EMDR+CT treatment targeted at
people with clinically relevant levels of PTSD who have been involved in a
traffic accident. The online CT consists of six weekly sessions.
Intervention: Six weeks of online EMDR combined with online CT. In week
1, participants will get an explanation of the online platform (Therapieland),
psychoeducation about PTSD, a questionnaire on what they would like to achieve
in treatment and an introductory meeting with their therapist. In week 2,
participants will learn about different forms of exposure and will perform a
writing assignment. Weeks 3-5 will consist of the online EMDR treatment. The
first two EMDR sessions will last 75 minutes each and the third EMDR session
will last 90 minutes to give therapist and participant the chance to discuss
the therapy and form a conclusion. In week 6, therapy will be concluded by
writing a letter to a loved one about the impact of the event and an evaluation
of goals that were set in week 1. During the weeks with no EMDR the participant
will have no contact with the therapist and will focus on the unguided therapy
sessions in Therapieland that they can finish in their own time. In weeks 7-12
participants will have no treatment.
Control group: The control group will consist of a waiting list in
weeks 1-6. After the six weeks are over, participants will get access to the
online cognitive module of Therapieland. This module will be the same as the
online EMDR+CT group, expect for weeks 9-11. In these three weeks (where the
online EMDR+CT group receives EMDR treatment), online EMDR will be replaced
with imaginal exposure including writing assignments, which is a science-based
treatment (Dawson et al., 2020).
Study burden and risks
Answering the survey questions could evoke painful thoughts or feelings related
to the traffic accident. The treatment could lead to a temporary increase in
PTSD symptoms. However, there are no indications based on prior research that
EMDR or CT results in an unacceptable risk of exacerbation of complaints.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
Have experienced at least 1 traffic accident at least one month prior to
participating;
Being >=18 years of age;
Reporting clinically relevant symptom-levels of PTSD based on self-report
questionnaires.
Exclusion criteria
Does not master the Dutch language;
Does not have access to Internet;
Can not participate in an online intervention due to medical complaints (e.g.,
neck complaints due to the accident).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77219.041.21 |