The main objective is to investigate whether trauma-focused therapy (TFT), as an addition to *treatment as usual* (TAU), is more effective compared to TAU only in reducing depression symptom severity in patients with CT-related depression.
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 after 12
weeks treatment (post-treatment), measured with the Inventory of Depressive
Symptomatology - Self Rated; IDS-SR.
Secondary outcome
1. Effectiveness of TAU + TFT compared to TAU by looking at: 1) remission in
CT-related depression after 12 weeks of treatment (post-treatment), 2)
depression symptom severity during the 12 week treatment, 3) depression symptom
severity and remission after 6 weeks of treatment, and 4) depression symptom
severity and remission at 6 months post-treatment (follow-up)
2. Other clinical outcomes related to TFT response: anxiety, disability,
insomnia, subjective stress and suicidal ideation and behavior
3. Descriptive variables (clinical factors and previous and current care), and
potential moderators and mediators related to TFT response
4. Stress-related biomarkers (to better understand how and for who TFT works):
• Hair cortisol levels: at baseline and post-treatment.
• Blood: at baseline and post-treatment for research on inflammatory and
(epi)genetic markers in relation to TFT response.
fMRI substudy
In a subgroup of 60 participants (matched for treatment allocation, age, and
sex), stress-related brain activity is measured with a +/- 60 minute fMRI
assessment before treatment and after 12 weeks of treatment, to better
understand the brain mechanisms of trauma-focused psychotherapy.
Background summary
Depression is a recurrent, debilitating psychiatric disorder with a lifetime
prevalence of 25%. Even though antidepressants and psychotherapy are often
effective, a substantial proportion of patients does not respond to currently
used evidence-based treatments. The heterogeneous nature of depressive symptoms
is a major obstacle for the development of novel, effective treatments and
targeted treatments for depression are currently lacking. There is increasing
evidence that depression related to childhood trauma (CT) is critically
different from non-CT related depression: it emerges earlier in life with more
severe and recurrent symptoms and has worse treatment outcomes. With a
prevalence of 25% in depressed patients, there is a large and unmet need for
novel therapeutic strategies for CT-related depression. Effective,
evidence-based trauma treatments, such as Eye Movement Desensitization and
Reprocessing (EMDR) and Imagery Rescripting (ImRs), are well investigated
treatments for trauma-related disorders, such as posttraumatic stress disorder
(PTSD). Currently, there is no targeted treatment available for CT-related
depression. Given the major role of trauma in CT-related depression, it is
plausible that trauma-focused psychotherapies may be effective in this
depression subtype. Therefore, this study investigates whether trauma-focused
therapy is effective in reducing depression and increasing remission in
CT-related depression. It is expected that trauma-focused therapy will be a
safe and rational strategy to enhance resilience and improve depression
outcomes for patients with CT-related depression.
Study objective
The main objective is to investigate whether trauma-focused therapy (TFT), as
an addition to *treatment as usual* (TAU), is more effective compared to TAU
only in reducing depression symptom severity in patients with CT-related
depression.
Study design
RESET-psychotherapy is a 12-week randomized controlled clinical trial
(single-blind RCT), in which TFT in combination with TAU will be compared to
TAU only at (various) sGGZ units of mental health care institutions GGZ
inGeest, HSK Groep, Altrecht, PsyQ and Pro Persona. Treatment allocation is
performed via simple randomization and blinded for assessors. As patients in
the intervention group (TAU+TFT) group) will receive more treatment sessions
compared to patients in the control group (only TAU), patients in the control
group will be offered extra contact moments with a researcher in order to
reduce the chance of an *attention effect*.
Intervention
After randomization, patients that are assigned to the TFT+TAU condition will
receive 6-10 sessions of trauma-focused therapy (TFT) in addition to regular
depression treatment (TAU). As part of TFT, treatment protocols for EMDR and
ImRs (EMDR if there was predominantly abuse and violence in childhood and ImRs
if there was predominantly neglect in childhood) with a focus on trauma
reprocessing of CT-related memories are followed, adapted to depression in
accordance to previously published treatment protocols.
Study burden and risks
Patients in the TFT+TAU condition will be offered 6-10 sessions of TFT added to
their regular depression treatment (TAU). Data will be collected during
multiple assessments: at baseline (T0), after 6 weeks (T1), after 12 weeks (T2;
post-treatment), and after 6 months post-treatment (follow-up, T3). The
baseline assessment will take approximately two hours. Completion of T1, T2,
and T3 measurements will take approximately 45 minutes. In addition, to obtain
information about depression symptom severity during treatment, patients are
asked to complete the IDS-SR online (duration 5 minutes) once in every two
weeks and only in those weeks that they do not already have a study assessment.
To better understand how and for who TFT works, stress-related biomarkers are
examined. Cortisol levels are assessed by collecting hair samples (baseline and
T2). At baseline and at post-treatment (T2), blood samples are taken for
measurements of inflammatory and (epi)genetic markers in relation to TFT
response. A sub-group of patients (N=60, 30 per intervention group) will be
asked to undergo a fMRI scan before the start of treatment and after 12 weeks
of treatment, to measure stress-related brain activity (approximately 60
minutes per fMRI session).
Patients are informed that they can cancel their participation at any time
without disclosing reasons for their cancellation and without negative
consequences for their future care. Participation in the study is associated
with a moderate amount of risks for patients. Both TAU and TFT will be offered
by experienced and qualified therapist.
The current study does not directly benefit participating patients. However, by
participating, the patient does help in the search for a better treatment for
people with depression and childhood trauma.
De Boelelaan 1108
Utrecht 3584CX
NL
De Boelelaan 1108
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 years
• Score >=26 on Inventory of Depressive Symptoms Self-Report (IDS-RS; moderate
to severe depression)
• DSM-5 diagnosis of major depressive disorder (MDD) confirmed with the Mini
International Neuropsychiatric Interview - Simplified; MINI-S for DSM-5
• Moderate to severe childhood trauma (CT): score above validated cut-off for
moderate to severe CT on one or more of the following domains using the
Childhood Trauma Questionnaire (CTQ): physical neglect: score >=10; emotional
neglect: score >=15; sexual abuse: score >=8; physical abuse: score >=10;
emotional abuse: score >=13.
• Sufficient mastery of Dutch language
• Patient is inclined to participate in a randomization process
• Patient in inclined to give written informed consent
Exclusion criteria
• Previous trauma-focused therapy on childhood trauma
• Other lifetime severe psychiatric comorbidity (psychotic disorder, bipolar
disorder) or current alcohol/drug dependence
• Primary diagnosis of post-traumatic stress disorder (PTSD) or acute stress
disorder (ASD)
• Lifetime diagnosis of borderline personality disorder
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 | NL74405.029.20 |