The primary aim of this study is to evaluate the effectiveness of face-to-face and online CBT (vs. waitlist) in reducing PCBD, depression and posttraumatic stress complaints in people bereaved by a traffic accident. The second aim is to study to…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PCBD, depression and PTSD.
PCBD: Traumatic Grief Inventory - Self Report (TGI - SR) (Boelen & Smid,
2017b).
PTSD: PTSS Checklist for DSM-5PCL-5 (Weathers, et.al., 2013)
depression: depression subscale of the Depression Hospital Anxiety and
Depression Scale (HADS-D; Zigmond & Snaith, 1983).
Secondary outcome
Secondary study parameters are the possibly mediating/moderating effect of
avoidance, maladaptive thoughts, anger, and accident-related stressors
Avoidance - Depressive and Anxious Avoidance in Prolonged Grief Questionnaire
(DAAGPQ; Boelen & van den Bout, 2010)
Maladaptive thoughts - Grief Cognitions questionnaire (Boelen &
Lensvelt-Mulders, 2005)
Anger - anger subscale of the State-Trait Anger Expression Inventory-2
(STAXI-2; Lievaart, Franken, & Hovens, 2016)
Accident-related stressors - Questions related to the accident (e.g.,
experiencing single or multiple loss(es))
Background summary
The Groningen-Utrecht research group of the applicants has been researching
grief and loss for a long time. With the support of FSH, research has been
conducted into the consequences of the loss for the left behind of various
forms of loss. In these studies in relatives of murder and the MH17 disaster
and relatives of missing persons, the nature and coping with problems is
combined with a treatment study for those relatives with a lot of psychological
problems and a need for help. The treatments are performed by a selected and
trained network of BIG-registered therapists who are spread throughout the
Netherlands. The so-called network therapists work locally together with the
case manager of Slachtofferhulp NL under the supervision of the applicants.
This creates a regional link that guarantees that the treatments can be offered
adequately to help requesting surviving relatives at the end of the research.
Recent reports on the position of road casualties and survivors in the
Netherlands (see: 1. Investigation report Criminal law response to traffic
offenses, Van der Aa et al, 2017, 2. Zwartboek, VVS, 2016) clarifies which
obstacles for traffic accident victims and NVD face. They have a lot of
problems with additional stressors, such as long procedures with the police,
justice, problems with insurers, (too) low compensation and penalties for
offenders. NVD with a high level of complaints will be offered a face-to-face
treatment or an online psychological treatment. These treatments effects are
compared with a wait-list control condition.
Question: What is the effect of a face-to-face (vs. waitlist controls) and
online treatment (vs. waitlist controls) in terms of reduction in
symptom-levels of PCBD, depression, and PTSD in bereaved people after a traffic
accident?
Based on intervention research at other groups of surviving relatives, we
expect that a targeted psychological face-to-face and online treatment is more
effective than no treatment (participation in the waiting list group, Boelen &
Smid, 2017a).
Additional questions: To what extent is the effect of the treatments
mediated/moderated by factors such as avoidance, negative thinking, anger, and
accident-related stressors?
Study objective
The primary aim of this study is to evaluate the effectiveness of face-to-face
and online CBT (vs. waitlist) in reducing PCBD, depression and posttraumatic
stress complaints in people bereaved by a traffic accident. The second aim is
to study to what extent the treatment effect is mediated/moderated by
avoidance, negative thinking, anger, and accident-related stressors.
Study design
People bereaved by a traffic accident who meet the criteria of PCBD, depression
and / or PTSD at least one year after death are eligible for participation. A
psychological treatment focused on traumatic grief (face-to-face or online)
will be offered and the effect of this treatment is investigated. The
psychological treatment (face-to-face or online) will be compared with a
waiting list control group (see below: interventions).
Earlier grief research shows that between 10-20% cooperates. It is expected
that over the period of 5 years, (per year 600 x 7 years = 3000 x 4 bereaved
people = 12,000, of this 15% cooperate =) potential 180 people can be included.
Bereaved people with clinically significant scores on questionnaires for PTSD,
PCBD and/or depression and a request for help (estimate: at least 10%) receive
a treatment indication. Within this group of at least 180 bereaved people
random allocation takes place a) face-to-face cognitive behavioral therapy b)
an online cognitive behavioral therapy or c) a waiting list control group. For
among others ethical reasons, persons from the waiting list control group will
receive face-to-face or online treatment at random after a waiting period of 20
weeks. The intervention groups start immediately after a pre-measurement with
the intervention. The required participation in the intervention groups to
answer the key questions is at least 146 people. Based on prior work, we expect
that this required number is achievable.
Measurement occasions face-to-face and online treatment conditions: T1 =
baseline measurement; T2 = post-intervention measurement (12 weeks), T3:
follow-up (20 weeks).
Measurement occasionswaitlist control condition: T1 = baseline measurement; T1a
= 12 weeks post waiting period, T1b = 20 week post-waiting period, T2 =
post-intervention (12 weeks after starting treatment), T3: follow-up (20 weeks
after starting treatment).
Midtreatment one brief assessment (12 item questionnaire about therapeutic
alliance) takes place.
Intervention
The starting point of both interventions offered is the cognitive behavioral
model of PCBD (Boelen, van den Hout, & van den Bout, 2007). This model states
that normal mourning, even after a long period of time persists through three
influencing mechanisms, namely 1) problems with elaborating and integrating the
loss; 2) negative cognitions and catastrophic misinterpretations of one's own
grieving reactions; 3) anxious and depressive avoidance behavior. Recent review
studies (Boelen & Smid, 2017a; Doering & Eisma, 2016) show that cognitive
behavioral therapy (CBT) is an effective form of treatment. Online CBT (Eisma
et al., 2015), in which a client is accompanied by a therapist via the
internet, also appears to be effective.
CBT usually consists of the following parts:
* Psycho-education contributes to the normalization of grief reactions. The
surviving relative understands that certain reactions to the loss, although
often new to themselves, are normal.
* Exposure helps break through fearful avoidance. Identifying and changing
non-helping thoughts contributes to a better interpretation of grief reactions
and more positive thinking about their own possibilities for loss processing
and about the future.
* Picking up and continuing meaningful activities helps to break down
inactivity and depressive avoidance of activities. All components together
strengthen the elaboration and thus the integration of the loss in the
autobiographical memory and thereby reduce the PCBD.
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 Grote Kruisstraat 2
Groningen 9712 TS
NL
Grote Kruisstraat 2 Grote Kruisstraat 2
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 a traffic accident
- * 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 do not master the Dutch language and do
not have access to Internet.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL69035.042.19 |
Other | Trial NL7497 |
OMON | NL-OMON20115 |