The primary goal is to investigate the effectiveness of Imagery Rescripting as an add-on intervention to care as usual (CAU) for treating clinical symptoms of depression of 15 adolescents who have been exposed to childhood trauma. The secondary…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is defined as depression symptom severity measured
with the self-report PHQ-9 three times a week during all phases and measured
with the IDS-SR at four time points: before phase A1, between phase A1 and
phase B, between phase B and phase A2, and after phase A2.
Secondary outcome
Secondary outcome measures are depression diagnosis and PTSD-diagnosis assessed
with a structured interview held at the start and at the end of the study. The
level of distressing mental images, suicidal ideation, post-traumatic stress
symptoms, resilience are measured at the four time points as described above.
Background summary
Depression in adolescence is a major mental health concern. Childhood trauma
(CT) is a well-established risk factor for poor (mental) health and, more
specifically, depression. Results indicate that CAU for depression is
insufficient for treating patients with depression who have been exposed to
childood trauma (c.q. childhood trauma related depression). This might suggest
that childhood trauma related depression asks for additional treatment. Imagery
Rescripting seems to be promising. In Imagery Rescripting negative childhood
memories are edited via imagination by rescripting them into a more benign
image, for example, by sending the patient*s alter ego in the image to comfort
or defend oneself as a child. Imagery Rescripting is already proven to be an
effective psychotherapeutic technique for a broad range of psychiatric
disorders in adults. There is some evidence for the effectiveness in treating
depressive disorder among adults. However, literature is scarce, especially for
adolescents.
Study objective
The primary goal is to investigate the effectiveness of Imagery Rescripting as
an add-on intervention to care as usual (CAU) for treating clinical symptoms of
depression of 15 adolescents who have been exposed to childhood trauma. The
secondary objective is to examine other clinical outcomes related to Imagery
Rescripting.
Study design
A Nonconcurrent Multiple-Baseline design with three within-series conditions
(phase A1, phase B and phase A2) and a randomization of units in staggered
intervention introductions will be used.
Intervention
During all three phases participants will receive CAU, weekly sessions (60
minutes) according to the Multidisciplinary Guidelines for Depression -
Addendum Youth. During phase B (intervention phase) the Imagery Rescripting
will be added and the effect will be investigated. Participants will receive 6
to 10 weekly sessions (90 minutes) of Imagery Rescripting with a focus on
processing childhood trauma related memories.
Study burden and risks
Imagery Rescripting is already proven to be an effective and safe treatment
technique in treating a broad range of psychiatric disorders. Participation may
be beneficial for patients, since they will receive an add-on intervention with
Imagery Rescripting that seems to be a promising technique for treating
childhood truama related depression.
The potential burden for patients is that they are asked to participate in data
collection by regularly filling in a short online self-report questionnaire
(three times a week), by filling in a set of online self-report questionnaires
at four time points and by a face-to-face interview held at the start and the
end of the study. Despite that the study population concerns a vulnerable group
of adolescents with clinical levels of depressive symptoms and possibly
suicidal ideation, we are convinced that the risks associated with participants
are minimal. Participation is embedded in a specialized mental health care
institution where (suicide) risk assessment and management is standard practice
of care.
Gezondheislaan 65
Oss 5432JW
NL
Gezondheislaan 65
Oss 5432JW
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Adolescents aged between 16 and 23 years in care at GGZ Oost Brabant
• Mastery of Dutch language
• Moderate to severe depression after 3 months of Care As Usual (CAU) for
depression:
o Score > 26 on the IDS-SR (Bernstein et al., 2007)
o DSM-5 diagnosis of depression, confirmed with the MDD part of the Mini
International Neuropsychiatric Interview - Simplified (MINI-S), Dutch version
1.1. for DSM-5 (Overbeek & Schruers, 2019).
• Moderate to severe childhood trauma (CT) before the age of 16
o At least one score above validated cut-offs for the CT subtypes of the
Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein & Fink, 1998;
physical neglect: score >10; emotional neglect: score >15; sexual abuse: score
>8; physical abuse: score >10; emotional abuse: score >13)
• In the case of suicidal ideation: The patient is in possession of an up to
date safety plan
• Patient is inclined to give written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• There is still immediate physical threat/harm/violence in the adolescent*s
life which acquires attention
i• There is a history of trauma-focused therapy with EMDR, imagery exposure or
Imagery Rescripting in regard to the traumatic childhood event
• There is alcohol/drug dependence or other sever psychiatric comorbidity (e.g.
bipolar disorder, psychotic disorder) that requires clinical attention
• There is a primary DSM-5 diagnosis of PTSD or Acute Stress disorder (ASD)
• There is acute suicide risk with an indication for hospitalization (further
elaborated in the research protocol p.18)
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 | NL83743.091.23 |