Our primary objective is to investigate whether EMDR and Imagery Rescripting are effective for individual patients who experience intrusions: patients with PTSD, patients with depression, and patients with PTSD and a comorbid depression. To this end…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
PTSS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a brief measure of characteristics of intrusions
(specifically, the frequency, uncontrollability, and degree of interference
with daily life), which will be assessed twice daily via an online link.
Additionally, process measures indexing possible mediators concern brief
questionnaires on emotion regulation, self-compassion, rumination, positive
affect, and the vividness, distress, and related meaning of intrusions, which
also serve as our primary outcome measures. These questionnaires will be
assessed daily. All primary outcome measures will be administered during the
baseline, experimental, and withdrawal phase.
Secondary outcome
Secondary outcome measures concern questionnaires on quality of life,
depression symptoms, and PTSD symptoms which are endorsed at baseline,
post-treatment (i.e., 4 weeks after the last intervention session, at the end
of the withdrawal phase), and at 6-month follow-up. A questionnaire about
outcome expectancies will be administered at baseline, and weekly during the
treatment phase.
Background summary
Patients with post-traumatic stress disorder (PTSD) experience highly frequent
and distressing intrusive images depicting earlier aversive experiences. Not
only patients with PTSD experience these intrusions; they are also very common
in depression. Therefore, trauma treatments that target these intrusions may
also benefit patients with depression.
Additionally, comorbid depression in patients with PTSD reduces the effects of
trauma treatment. It is currently unknown which treatment for traumatic
intrusions is most effective for patients who meet criteria for PTSD,
depression, or both, and treatment selection is often a process of trial and
error. The mechanisms of action of trauma treatments may inform us how to
select the most appropriate treatment for a particular individual.
Study objective
Our primary objective is to investigate whether EMDR and Imagery Rescripting
are effective for individual patients who experience intrusions: patients with
PTSD, patients with depression, and patients with PTSD and a comorbid
depression. To this end, we will examine the patterns of the reduction in the
severity of intrusions (i.e., frequency, uncontrollability, and degree of
interference with daily life) within each individual and within each of the six
groups (i.e., three patient groups and two interventions). In this way, we want
to gain more insight into the mechanisms of action of both treatments. We will
specifically investigate the potential mediating roles of self-compassion,
emotion regulation, positive affect, rumination, the vividness and distress of
intrusions, and intrusion-related beliefs about oneself.
Our second objective is to investigate the effect of EMDR and IR on quality of
life, PTSD and depression symptoms in each individual and within each group.
Our third objective is to explore the patients* and therapists* perspectives on
deciding factors in treatment selection, by asking them about preferences and
expectations concerning EMDR and IR.
Study design
The present study uses a single-case experimental design with a baseline phase,
an experimental or treatment phase, and a withdrawal of treatment phase, as
well as a 6-month follow-up.
Intervention
Patients will be randomly assigned to EMDR or IR. In each condition, patients
will receive two 75-minute sessions of EMDR or IR each week, as well as an
additional coaching session each week. Treatment length depends on patients*
needs and varies between 2.5 and 6 weeks.
Study burden and risks
There is a regular procedure for patients who are referred to the *Kortdurende
Intensieve Trauma Traject* (KITT) of GGzE, which involves assessment as well as
treatment (EMDR or IR). Participation in the study requires completing
additional questionnaires for research purposes at baseline, post-treatment,
and follow-up (18 min each time), as well as daily measures during the
baseline, treatment, and withdrawal phases. There are two daily measures. Once
every week, questions about Outcome Expectancies will be added, which will take
an additional 2 minutes to complete. One of the daily measures indexes
intrusions only and will take 2 minutes to complete. The second daily measure
assesses intrusions as well as the potential mediators and will take 7 minutes
to complete. There are no known risks associated with the completion of the
questionnaires for the study. The total study duration (baseline up to and
including the withdrawal phase but excluding the 6-month follow-up) is a
minimum of 8.5 weeks and a maximum of 12 weeks, depending on the number of
intervention sessions patients receive. In addition to the time required for
the study, a potential burden for patients is the fact that they are randomized
to one of two interventions and, therefore, cannot choose their preferred
treatment. The benefits of the study include a better understanding of the
effectiveness of EMDR and IR for different patient groups, and the mechanisms
underlying the treatment effects. In addition, patients may benefit from
self-monitoring through completion of questionnaires throughout the study
period. Patients who have completed the study will be offered a feedback
session on their questionnaires and changes in scores after the 6-month
follow-up, which may help to guide any further treatment of the patients.
Patients will receive a financial compensation varying from ¤60 to ¤80 in
VVV-vouchers, depending on their time investment in the study.
Dr. Poletlaan 39
Eindhoven 5626 NC
NL
Dr. Poletlaan 39
Eindhoven 5626 NC
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 70 years;
- Experiencing intrusions and/or nightmares;
- Meet criteria for unipolar depressive disorder, PTSD, or both disorders;
- Past aversive events still cause considerable distress;
- Be available for trauma treatment twice a week, with an additional coaching
session each week;
- Be proficient in the Dutch language.
Exclusion criteria
- A dissociative identity disorder;
- Acute suicide risk;
- Acute psychosis;
- Substance use disorder;
- Bipolar disorder type 1 and 2.
Design
Recruitment
Medical products/devices used
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 | NL85848.068.23 |