The primary goal of this study is to compare the effectiveness of an exposure therapy module with a behavioral activation module and a control group in reducing rumination and complicated grief symptoms. A secondary goal of this study is to compareā¦
ID
Source
Brief title
Condition
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are (grief) rumination and complicated grief symptoms.
Secondary outcome
Secondary outcome measures are depressive rumination and symptoms of anxiety,
depression and posttraumatic stress disorder. Control variables are demographic
variables (i.e. age, gender, education level), loss-related variables (time
since loss, relationship with deceased, gender deceased, expectations about the
loss) and medication use. Moreover, the therapist(s) will fill out a
registration form on therapeutic adherence and motivation of the participant.
Background summary
The loss of a loved one is one of the most stressful events a person can
experience. Although most people adjust to the loss of a loved one without
professional intervention, some people develop physical and mental problems and
or grief complications. An important, potentially changeable risk factor in the
development of grief complications is rumination. Rumination has been defined
as recurrent, self-focused thinking about negative events and/or negative
feelings. Rumination after bereavement has been associated with, and is a
predictor of, complicated grief symptoms. Because rumination is a risk factor
in the grief process, therapeutic treatment for complicated grief can focus on
altering levels of rumination. By lowering levels of rumination, a reduction of
grief symptoms can be achieved.
Chronic rumination is presumed to be maladaptive because it plays a role in
avoidance processes. First, continuous rumination may serve to avoid painful
aspects of the reality of the loss and the emotions linked with it, thereby
interfering with the acceptance of, and adjustment to, the loss. Second,
chronic rumination may play a role in stimulating inactivity, because it takes
up time and strengthens the idea that all is hopeless after the loss and
nothing can be done to change this situation. As a consequence, bereaved
ruminators have less positive experiences that could invalidate their negative
thoughts, thereby fueling negative mood.
Because rumination in the context of bereavement appears to be inherently
linked with anxious avoidance of the reality of the loss and depressive
avoidance of activities, rumination could be reduced by influencing these
avoidance processes. First, exposure techniques could be used to confront
bereaved ruminators with the reality of the loss, which could increase the
acceptance of the loss and the integration of the loss in the autobiographical
knowledge base. Exposure could also diminish rumination, because confronting
the painful aspects of the reality of the loss would reduce the need to rely on
rumination to avoid this reality. Second, behavioral activation could be used
to reduce inactivity. Behavioral activation could also reduce rumination,
because bereaved individuals who are more active have less time to ruminate.
Furthermore, they may also have less reasons to ruminate, because negative
affect, an important cause of rumination is the experience of negative affect.
Since exposure therapy has repeatedly been found effective in the treatment of
complicated grief , while there is currently no conclusive evidence that
behavioral activation may be effective in reducing complicated grief symptoms,
we expect exposure to be a more effective treatment of rumination and
complicated grief symptoms than behavioral activation.
In the proposed intervention study the effects of short, internet based
exposure and behavioral activation will be compared with each other and an
internet control group. We expect that exposure and behavioral activation will
reduce rumination and symptoms of complicated grief more strongly than the
control group. Furthermore, we expect exposure to be more effective than
behavioral activation in reducing rumination and symptoms of complicated grief.
Finally, we expect that decreases in rumination and complicated grief symptoms
in the exposure condition will be more strongly associated with reductions in
anxious avoidance of the loss-reality, when compared with the behavioral
activation condition. Furthermore, we expect that decreases in rumination and
complicated grief symptoms in the behavioral activation condition will be more
strongly associated with reductions in depressive avoidance of activities, when
compared with the exposure condition.
Study objective
The primary goal of this study is to compare the effectiveness of an exposure
therapy module with a behavioral activation module and a control group in
reducing rumination and complicated grief symptoms. A secondary goal of this
study is to compare the association between reductions in rumination and
complicated grief symptoms and reductions in anxious and depressive avoidance
between treatment groups.
Study design
A randomised controlled trial (RCT) in which two internet-based treatments for
chronic rumination and grief complications will be compared with each other and
a control group.
Intervention
Participants will be randomly assigned to one of three conditions: an exposure
module of 6 weeks, a behavioral activation module of six weeks or a waiting
list control group. Participants who are assigned to the waiting list control
group will receive the most effective of both treatments after their initial
waiting period.
Study burden and risks
The treatment participants receive can be emotionally taxing, because
participants are confronted with the reality of their loss (exposure condition)
or aversive situations (activation condition). However, participation is
completely voluntary. Furthermore, the treatment is based on effective existing
treatments or treatments for which preliminary evidence of its effectiveness
exists. The treatment will be implemented by qualified therapists. Participants
will do 6 homework assignments over 6 weeks and fill out questionnaires at 4
time-points. All questionnaires are valid and frequently used in scientific
research. The relevance of the study is great, because it provides new insights
into the effectiveness of intervention modules in reducing rumination and
symptoms of complicated grief. This is important, because it can improve
existing psychological treatments of grief. See also Paragraph 9.3.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
1) The participant is 18 years or older
2) The participant has been bereaved of a partner, child, parent or sibling at least 6 months ago.
3)The participant expresses a need for psychosocial help with dealing with his or her loss.
4) The participant has elevated scores on grief rumination (>42) measured with the Utrecht Grief Rumination Scale
5) The participant has elevated scores (>25) on symptoms of complicated grief measured with the short version of Inventory of Complicated Grief (ICG);See paragraph 4.2 of the research protocol for details on inclusion criteria.
Exclusion criteria
1) The participant has no or limited access to internet.
2) The participant currently suffers from a severe depressive episode
3) The participant currently suffers from suicidal ideation
4) The participant has recently experienced dissociation or psychotic symptoms
5) The participant is physically disabled, in the sense that he or she is limited in physical mobility;See paragraph 4.3 of the research protocol for details on exclusion criteria.
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 | NL43072.042.12 |