No registrations found.
ID
Source
Brief title
Health condition
Post-traumatic stress disorder (PTSD), major depressive disorder (MDD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD: PTSD Checklist for DSM-5 (PCL-5; Weathers, et.al., 2013)
Secondary outcome
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Rumination: Brooding subscale of the ruminative response scale (RRS; Treynor et al., 2003)
Self-efficacy: General self-efficacy scale (GSES; Schwarzer & Jerusalem, 1995)
Acceptability of treatment: 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
The primary aim of this study is to study the effectiveness of online EMDR+CT (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.
Secondary aims are (i) to assess the effectiveness of online CT, (ii) to assess the effectiveness of online EMDR+CT compared to online CT, (iii) to examine rumination and self-efficacy as correlates of change, and (iv) to assess the acceptability of online treatment.
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.
Eligible for participation are people who have been involved in a traffic accident at least one month prior to participating and are currently experiencing clinically relevant levels of PTSD (as indicated by the PCL-5 questionnaire)
Study objective
We expect that people allocated to the EMDR+CT condition will show lower symptom-levels of PTSD and depression post-treatment compared with waitlist controls post-waiting (Hypothesis 1).
Additionally, we expect that people allocated to the waitlist followed by online CT will show lower PTSD and depression levels post-treatment compared to their own post-waiting symptom-levels (within-person; Hypothesis 2), that people allocated to the online EMDR+CT group will show lower symptom-levels of PTSD and depression post-treatment than those allocated to the online CT group post-treatment (Hypothesis 3), and that that a reduction in rumination and improvement in self-efficacy will be related to reductions in PTSD and depression symptom-levels post-treatment in both intervention condition (Hypothesis 4).
Study design
Online EMDR+CT condition: pre-treatment and 6 weeks post-allocation
Online CT: pre-treatment, 6 weeks and 12 weeks post-allocation
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 cognitive therapy (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.
Control group: The control group will be allocated to a (no-treatment) waiting period, in weeks 1-6. After these six weeks, participants in the control group will get access to the online cognitive therapy (CT) module of Therapieland. Similar to online EMDR and online CT (the experimental intervention), the CT module is a six week intervention. It includes writing assignment focused on identifying and altering maladaptive cognitions and evidence-based writing assignments focused on processing memories associated with the accident (cf. Dawson et al., 2020). No EMDR is included in this CT module.
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 post-traumatic stress disorder (PTSD) based on self-report questionnaires.
Exclusion criteria
Does not master the Dutch language; Does not have access to Internet; Cannot participate in an online intervention due to medical complaints (e.g., neck complaints due to the accident).
Design
Recruitment
IPD sharing statement
Plan description
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 |
|---|---|
| NTR-new | NL9641 |
| Other | METC UMCU : 21-271/D |