The primary aim in part 1 of this study is to evaluate the effectiveness of unguided online CBT (vs. waitlist controls), in terms of reductions in PCBD, PTSD, and depression symptom-levels, for people who lost a loved one during the COVID-19…
ID
Source
Brief title
Condition
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PCBD, PTSD, and depression
PCBD: Traumatic Grief Inventory - Clinician Administered (TGI - CA; Boelen,
Smid, & Lenferink, 2019).
PTSD: PTSS Checklist for DSM-5PCL-5 (PCL-5; Weathers, et.al., 2013)
Depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Secondary outcome
not applicable
Background summary
Losing a loved one in traumatic circumstances, for instance a sudden or violent
death, increases the risk of developing symptoms of persistent complex
bereavement disorder (PCBD), posttraumatic stress disorder (PTSD), and
depression. The death of a loved one during the COVID-19 pandemic could be
considered a potentially traumatic loss, that likely results in high rates of
PCBD, PTSD, and depression compared with the natural loss of a loved one. The
interplay between the increase in deaths and corona-related stressors likely
leads to an elevated risk for difficulties in the grieving process and thus an
increase in number of people seeking professional grief support. Grief-specific
cognitive-behavioural therapy (CBT) is considered the most effective treatment
option for bereaved people. CBT for bereaved people aims to change maladaptive
thoughts and to reduce avoidance behaviour. To date, CBT has mostly been
delivered through individual face-to-face formats, while treatment studies have
shown that online treatment also yields promising results. Offering treatment
online is now more than ever relevant during the pandemic and may offer
important benefits compared with face-to-face CBT, such as lower costs and
higher accessibility. In part 1 of the current study, our first hypothesis is
that people allocated to a condition with unguided online CBT will show lower
PCBD, PTSD, and depression symptom-levels post-treatment than people allocated
to a waitlist (prior to obtaining this online treatment). Our second hypothesis
is that treatment effects on PCBD, PTSD and depression symptom levels will
persist from pre-treatment through six months post-treatment. In part 2 of the
current study, our first hypothesis is that both guided and unguided online CBT
lead to a decrease in the severity of PCBD, PTSD and depression symptom levels.
Our second hypothesis is that participants allocated to a condition with
therapist guided online CBT will show a stronger decrease in PCBD, PTSD and
depression symptom levels post-treatment and at six months post-treatment than
participants allocated to a condition with unguided online CBT.
Study objective
The primary aim in part 1 of this study is to evaluate the effectiveness of
unguided online CBT (vs. waitlist controls), in terms of reductions in PCBD,
PTSD, and depression symptom-levels, for people who lost a loved one during the
COVID-19 pandemic.
The primary aim in part 2 of this study is to evaluate the effectiveness of
guided online CBT (vs. unguided online CBT), in terms of reductions in PCBD,
PTSD and depression symptom-levels, for people who lost a loved one during the
COVID-19 pandemic.
Study design
In part 1 of the study, a two-arm (unguided online CBT vs. waitlist controls)
open label parallel monocentre randomized controlled trial will be conducted.
Pre-treatment/pre-waiting period, post-treatment or post-waiting period and six
months post-treatment symptom-levels of PCBD, PTSD, and depression will be
assessed by clinical telephone interviews. For participants allocated to the
waitlist control condition, an additional assessment will take place
post-treatment after the waiting period. All participants in part 1 of the
study will serve as a control group (unguided online CBT) in part 2 of the
study.
In part 2 of the study, a two-arm (guided online CBT vs. unguided online CBT)
open label multicentre controlled trial will be conducted. All participants in
part 2 of this study will be allocated to a guided online CBT condition.
Self-rated symptom-levels of PCBD, PTSD and depression will be assessed at
pre-treatment, post-treatment and six months post-treatment by telephone
interviews.
Intervention
In part 1 of the study, the intervention consists of an unguided online CBT for
disturbed grief. In part 2 of this study, the intervention consists of a guided
online CBT for disturbed grief. The starting point for this intervention is CBT
for PCBD (Boelen & van den Bout, 2017). Reviews show that CBT is the most
effective treatment for people who experience difficulties during the grieving
process (Boelen & Smid, 2017; Doering & Eisma, 2016).
The online intervention 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 to 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 processing the
loss and cope with the future.
• Picking up and continuing meaningful activities helps to counter 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 PCBD symptom levels.
All participants receive the same information; the content of the intervention
is therefore not dependent on the input from the user.
Study burden and risks
Answering the interview questions 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 does not lead to increase of psychological
distress after treatment (Currier, Holland, & Neimeyer, 2010)
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- be a family member, spouse, or friend of a person who died (whether or not
due to corona) in the COVID-19 pandemic (period March 2020 till current);
- the death occurred at least three months earlier (this is in line with prior
research, see Litz et al., 2014);
- be >=18 years of age;
- report clinically relevant symptom-levels of PCBD, PTSD, and/or depression
based on interviews.
Exclusion criteria
- does not master the Dutch language;
- does not have access to Internet;
- suffers from a psychotic disorder or is 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 | NL74518.041.20 |
Other | NL8993 |