Main research question:Does group-based schema therapy result in a reduction of depressive symptoms when comparing symptom change during the treatment to patients* baseline symptom level?Sub research questions:Does group-based schema therapy result…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depressive symptoms as measured by the QIDS-SR.
Secondary outcome
Maladaptive schema strength: The five domains of the Dutch translation of the
Young Schema Questionnaire 80 (YSQ-80) will be administered at baseline
(Rijkeboer, 2008).
Maladaptive and adaptive modi strength: Using the 118 items of the Short Schema
Modi Inventory (Short SMI), 16 maladaptive modi 16 maladaptive modi and two
adaptive modi will be measured (Lobbestael, van Vreeswijk, Spinhoven, Schouten,
& Arntz, 2010).
Selective memory bias: Participants will carry out the Self-Referent Encoding
Task (SRET) to measure selective negative memory bias using schema words (Derry
& Kuiper, 1981; Hammen & Zupan, 1984). Participants are presented with positive
and negative self-descriptive words and have to indicate how self-relevant
these words are. After a brief distraction task, their memory for these words
is tested via een a free recall procedure.
Propositional memory bias: Using a customised version of the Propositional
Evaluation Paradigm (PEP) computer task, EMS-strength will be implicitly
measured (Muller & Rothermund, 2019). Participants are presented with short
sentences adapted from the YSQ-80 items and are asked to answer with *true* or
*false. Using reaction time differences between *true* and *false* prompts, an
implicit attitude can be measured. Mouse-tracking will also be used to assess
the implicit attitude whilst an answer is being chosen.
Trait rumination: The Rumination Response Scale (RRS-NL) will be used to
measure trait rumination (Raes et al., 2009).
Distancing from modi: The Inclusion of Others in the Self (IOS) measures
interpersonal closeness and has previously been adapted for other uses like
PTSS (Aron et al., 1992). A new and experimental version of the IOS has been
made for measuring overlap with schema modi using the same item as the IOS but
replacing *Other* with *Modi* called the Inclusion of Modi in the Self (IMS).
Sense of Mastery: Sense of mastery will be measured using the
RemoralisatieSchaal (RS) consisting of 12 items (Vissers, Keijsers, van der
Veld, de Jong, & Hutschemaekers, 2010).
Lifestyle: To measure the influence of lifestyle habits and choices the Healthy
Lifestyle and Personal Control Questionnaire (HLPCQ) will be administered
(Darviri et al., 2014).
Demographics: In addition to the clinical and schema-related questionnaires,
date of birth, gender, mother tongue, living situation, education and
occupation wil be assessed using a demographics questionnaire at the start of
the study,
Background summary
Despite the increased use of Schema Therapy (ST) within the treatment of
patients with a Treatment Resistant Depression (TRD), little research has been
done on the effectiveness and the underlying working mechanisms. The limited
available literature suggests that ST is successful at treating the underlying
risk factors of TRD which results in a reduction of depressive symptoms (Renner
& Arntz, 2013; Malogiannis et al., 2014). These studies, although good first
steps, are limited by small sample sizes, lack of a good control condition and
quantity of studies. Research focussing specifically on underlying working
mechanisms of ST for TRD is limited with only one study available. It focussed
on two possible mechanisms: changes of maladaptive schemas and therapeutic
alliance (Renner et al., 2018). Both mechanisms changed together with
depressive symptoms, suggesting that other mechanisms underlie the effect of ST
for TRD. Further research is needed to discover these working mechanisms.
One possible working mechanism of ST for patients with TRD is the effect of
memory bias on schemas storage and retrieval. Following Beck's theory for
depression (1967), schemas develop through early childhood experiences and are
stored in memory. Expanding on this theoretical model, Young emphasizes the
importance of the Early Maladaptive Schemas as underlying pathological
behaviour in his schema theory (Young, 1990). Schemas are assumed to be stored
in memory and, when activated by a triggering event, play a role in the
development and maintenance of a depressive episode. Previous research in
patients with a depression showed that through memory biases patients were more
likely to retrieve negative information from memory as opposed to positive or
neutral information (Mechera-Ostrovsky and Gluth 2018). This negative memory
bias might affect the retrieval and activation of early maladaptive schemas
(LeMoult & Gotlib, 2019).
By increasing our understanding of ST for TRD, its application in the clinical
practice can be better substantiated and ST theory can be improved.
Understanding the working mechanism of ST in TRD can lead to better tailored
treatment.
Study objective
Main research question:
Does group-based schema therapy result in a reduction of depressive symptoms
when comparing symptom change during the treatment to patients* baseline
symptom level?
Sub research questions:
Does group-based schema therapy result in a reduction of schema strength
frequency in depressed patients?
Does group-based schema therapy lead to a relief in strength of maladaptive
modi?
Does group-based schema therapy lead to an increase in strength of adaptive
modi?
Zorgt groepsschematherapie voor een vermeerdering van de sterkte van adaptieve
modi?
Are changes in emotional memory bias, schema self-associations or state
rumination possible mechanisms of changes of group-based schema therapy?
Is reduction of depressive symptoms preceded by frequency of maladaptive modi,
distancing of maladaptive modi and sense of mastery?
Group schema therapy is expected to lead to a reduction in depressive symptoms,
when comparing patients with their own baseline as a reference point in a
multiple-baseline design. additionally, it is expected that the various
possible mechanisms of change can partially explain the reduction of symptoms.
Study design
Due to the vulnerable target group and the long duration of the group schema
therapy, a RCT is not appropriate nor feasible. A *non-concurrent
multiple-baseline between subject design* will be used (Morley, 2018). During a
period of two years, participants in treatment through the schema therapy group
at the TOPGGz, Pro Persona Expert Center for Depression will be included and
assigned to the different baseline starting measurements. During a period
varying from 32 to a maximum of 38 weeks, participants will complete the
QIDS-SR weekly at home to precisely assess depressive symptoms. At the start of
the study, a baseline test battery will be administered which will take
approximately 10 minutes to complete. During the further study period,
participants will additionally visit the site six times for a more extensive
battery of trests. During these extended measurements, early maladaptive
schemas, schema modes, depressive symptoms, overlap between self and schemas,
remoralisation, trait rumination, implicit association, implicit attitude,
mood, arousal, childhood trauma, and lifestyle will be measured. The
instruments summarised below will , varying in frequency, be administered at
these six moments. The extensive measurement moments will last from 30 to 90
minutes each. The weekly measurements will take less than two minutes.
Inventory of Depressive Symptomatology-Self Report
Young Schema Questionnaire-80
Short Schedule Modes Inventory
The Inclusion of Maladaptive Modi and Self
RemoralizationScale
Rumination Response Scale
Implicit Relationship Assessment Procedure
Propositional Evaluation Paradigm task
Visual Analogue Scale for mood and arousal
Healthy Lifestyle and Personal Control Questionnaire
Study burden and risks
Not applicable.
Nijmeegsebaan 61
Nijmegen 6525 DX
NL
Nijmeegsebaan 61
Nijmegen 6525 DX
NL
Listed location countries
Age
Inclusion criteria
• Adult defined as 16 years or older;
• Primary diagnosis is treatment resistant or recurrent depression according to
DSM-5 criteria evident from the MINI 5.0;
• IDS-SR score of 26 or higher, indicating average, severe or very severe
depressive symptoms;
• Evident from the intake interview report: a pattern of noticeable behaviour
or internal experience which can be typed as traits of a personality disorder;
• Evident from the intake interview report: a previously used evidence based
psychological treatment (e.g. CBT, IPT, CBASP) or pharmacological treatment for
treatment resistant depression or for the current depression in case of
recurring depression;
Exclusion criteria
• Primary diagnosis is personality disorder;
• Current psychotic disorder;
• Lifetime bipolar disorder, substance use disorder or autism spectrum disorder;
• Insufficient mastery of the Dutch language;
• Impossibility to give a valid informed consent;
• Cognitive or intellectual impairments (IQ below 80) interfering with
participation judged by the therapist;
• Changes in treatment policy caused by suicidal ideations or medication
changes;
• Contraindication to group therapy at the end of the case conceptualization.
The two most obvious indications are presence of Angry Child-Bully and
Attack-Enraged Child coping mode.
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 | NL80090.091.21 |