The primary aim of this study is to evaluate the effectiveness of CBT and EMDR in reducing PCBD, depression and posttraumatic stress complaints in relatives of the Plane Crash Ukraine victims. The second aim is to study to what extent the treatment…
ID
Source
Brief title
Condition
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the difference in severity of
PCBD-complaints, depression and posttraumatic stress complaints of the
intervention after 18 months group compared to the intervention after 21 months
group (c.q. the waitlistgroup) at the post measurement.
Secondary outcome
The secondary study parameters are the possibly mediating effect of reduction
of maladaptive thoughts, avoidance behavior and intrusive memories in reducing
PCBD of the immediate intervention group compared to the delayed intervention
group at the post treatment assessment and the long-term effects of the
treatment in terms of reductions in PCBD, PTSD and MDD.
Background summary
Almost 300 people died after the Plane Crash in Ukraine on the 17th of
July 2014. Acute grief complaints are the expected response to the loss of a
loved one. Acute grief reactions decrease to an acceptable level after 6 months
for the vast majority (Bonanno, et al., 2002; Bonanno, Wortman, & Nesse, 2004).
When grief reactions persist or increase it can be defined as Persistent
Complex Bereavement Disorder (PCBD) (Shear, et al., 2011). Approximately 5 to
10% of bereaved individuals develop PCBD (Middleton, Raphael, Burnett, &
Martinek, 1998; Prigerson, et al., 2009). For those who lost a loved one due to
a disaster, estimated percentages of PCBD range from 40 to 70% (Ghaffari-Nejad,
Ahmadi-Mousavi, Gandomkar, & Reihani-Kermani, 2007; Neria, et al., 2007). PCBD
is associated with, yet distinct from Posttraumatic Stress Disorder (PTSD) and
major depressive disorder (MDD) (Boelen, van de Schoot, van den Hout, de
Keijser & van den Bout, 2010; Prigerson, et. al., 1996).
Various interventions are developed for those who experience a distorted
grieving process. However, many intervention-studies lacked a strong design and
results are unstable (Currier, Holland & Neimeyer, 2010). More robust research
into the effectiveness of grief treatments is needed to adequately support
bereaved persons who develop psychopathology.
The effectiveness of cognitive behavioral therapy (CBT) and eye movement
desensitization and reprocessing (EMDR) in the treatment of PTSD and related
disorders has been studied in diverse populations (see for example the review
of Ponniah & Hollon, 2009). Preliminary results of an intervention study among
homicidally bereaved persons with PCBD show the beneficial effect of CBT
combined with EMDR (van Denderen, de Keijser, & Boelen, in preparation). The
CBT-part of the latter study aims at changing maladaptive thoughts and
diminishing avoidance behavior, while EMDR aims at integrating intrusive
memories that are related to the loss. We hypothesize, based on previous
studies, that CBT and EMDR are effective in reducing PCBD as well as PTSD and
MDD among bereaved persons who lost a relative due to the Plane Crash Ukraine.
Study objective
The primary aim of this study is to evaluate the effectiveness of CBT and EMDR
in reducing PCBD, depression and posttraumatic stress complaints in relatives
of the Plane Crash Ukraine victims. The second aim is to study to what extent
the treatment effect is mediated by reduction of maladaptive thoughts,
avoidance behavior and/or intrusive memories.
Study design
By conducting a two-arm (intervention after 18 months versus intervention after
21 months) randomized controlled trial, we aim to fulfill both study
objectives. The participants are asked to fill in questionnaires prior to the
treatment and within one week, 12 and 24 weeks post treatment.
Intervention
The intervention consists of eight sessions: Session 1 is an introductory
session, in session 2 mourning in the family is discussed. In session 3, 4, and
5 eye movement disensitization and reproccessing (EMDR) is applied, which take
up to 90 minutes. In session 6, 7, and 8, cognitive behavioral therapy (CBT) is
used. These sessions last up to 45 minutes.
By handing out a manual (based on the manual of the homicide-study) the
participant will receive psycho-education and learn how to handle maladaptive
thoughts.
Study burden and risks
Filling in the questionnaires could evoke painful thoughts or feelings related
to the death of the loved one(s). The treatment could lead to a temporary
increase in distress. Different studies with trauma victims and bereaved
individuals showed that CBT and/or EMDR does not lead to increase of
psychological distress after treatment (Currier, Holland, & Neimeyer, 2010;
Ponniah & Hollon, 2009).
Grote Kruisstraat 2/1 Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1 Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
- First, second and third degree (adoption- or step) familymembers, and spouses or friends of persons who died at the Plane Crash Ukraine;
- >= 18 years of age
- meet the criteria for Persistant Complex Bereavement Disorder (PCBD), Posttraumatic Stress Disorder (PTSD) and/or Major Depressive Disorder (MDD) based on questionnaire scores.
Exclusion criteria
Participants will be excluded when they suffer from a substance use disorder, psychotic disorder or mental retardation and when they are suicidal.
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 | NL52722.042.15 |
Other | registratie under review bij Nederlands Trial Register |