To evaluate DIT treatment outcome and possible predictors of treatment outcome in patients with MUSS To evaluate brain structure and function related to SSD pre-and post treatment.
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study predicts a beneficial effect of DIT therapy on several parameters:
- Compared to a waiting list group, subjects show an increase in mentalization
(about oneself and others), a decrease in levels of stress, pain and fatigue,
functional disability.
- Associations between childhood trauma and brain structure and function are
expected. We expect that structural and functional brain abnormalities realted
to trauma play a role in SSD symptoms and that DIT treatment may reverse these
abnormalities.
Secondary outcome
we will examine the role of possible moderators in the effect of DIT: childhood
trauma, attachment, comorbidity.
Background summary
The current study aims to examine the effects of Dynamic Interpersonal Therapy
(DIT) in patients diagnosed with Somatic Symptom Disorder (SSD). Previous
research has shown that patients with SSD experience difficulty in mentalizing
about own and others* feelings and that negative childhood experiences and
attachment issues can predispose an individual for mentalization difficulties.
Furthermore, these patients have been found to be self-critical and
perfectionistic which can result in a dysfunctional stress response. Currently,
guidelines recommend Cognitive Behavioural Therapy in the treatment of SSD
(CBT). However, CBT does not target underlying psychodynamic factors such as
mentalization abilities or attachment. Dynamic Interpersonal Therapy (DIT) is
a new treatment that does address psychodynamic factors. Treatment with DIT
might result in better outcomes for individuals with MUSS. The proposed study,
therefore, aims to examine the effects of DIT in physical and psychological
symptoms in patients with SSD.
In addition, the proposed study aims to examine the possible role of structural
and functional brain abnormalities in the link between negative childhood
experiences and SSD. Previous research has shown that negative childhood
experiences result in structural and functional brain abnormalities, but it is
unknown how this relates to symptoms in patients with SSD. In the current
study, we will examine how structural and functional brain abnormalities in
MUSS patients are related to MUSS symptoms, taking into account the role of
childhood trauma. In addition, we will examine whether brain abnormalities can
be reversed with treatment.
Study objective
To evaluate DIT treatment outcome and possible predictors of treatment outcome
in patients with MUSS
To evaluate brain structure and function related to SSD pre-and post treatment.
Study design
Study design: Patients with SSD who are selected for DIT, will be asked to
participate in this study to examine the effects of DIT on SSD severity and
social functioning. Participants will be asked to fill out online
questionnaires measuring attachment experiences, physical symptoms,
mentalization of own and others* emotions. Patients will receive Dynamic
Interpersonal Therapy, two days per week (total of 10 hours per week) for 24
weeks. A subsample will be invited for an MRI session before and after
treatment.
Study burden and risks
There are no benefits for patients or controls when they participate in the
current study. Participants will not receive money or other rewards. There is
no physical burden associated with participation. Participants might experience
emotional burden from filling out questionnaires about negative childhood
experiences. Participants will be explained that they can withdraw from
participation at any point during the study without consequences for their
treatment. They will be given contact information of an (independent)
psychiatrist in case they experience any negative emotions as a consequence of
completing the questionnaires.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
Patients with SSD: participants (age 18 -65 years) should suffer from medically unexplained somatic symptoms (MUSS) (e.g. chronic somatic unexplained headaches, chronic fatigue syndrome, unexplained dizziness, whiplash-related complaints, fibromyalgia and irritable bowel syndrome) with no or insufficient medical explanation.
Exclusion criteria
MUSS symptoms present for less than 6 months, another psychiatric disorder as main classification, age <18 or >65, insufficient mastery of the Dutch language, and unregistered drug or alcohol abuse. Comorbidity and use of psychopharmaceuticals
Patients who agree to participate in the MRI study will be screened for MRI contraindications. Contraindications are metal implants or other metal objects that can not be removed, (possible) pregnancy, and claustrophobia.
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 | NL68529.028.18 |