Primary Objective: To determine whether short-term experiential ST improves overall wellbeing in adult out-patients with cluster C PD, directly after treatment, at 3 months treatment follow-up (treatment-FU), and at 6 month measurement-FU. 6 months…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See the METC protocol 8.1 (page 20) for more information about the measurement
method, instruments and assessment moments.
Overall wellbeing (ORS)
To asses change in overall wellbeing after pre-treatment, treatment, 3 months
treatment-FU and at 6 months measurement-FU (compared to baseline),
participants will fill in the Outcome Rating Scale (ORS; Miller & Duncan, 2000;
Miller, Duncan, Brown, Sparks, & Claud, 2003; Dutch manual by Crouzen, 2010).
Participants will fill in this questionnaire once every two days during phase
A1, twice a week during phase B1, once a week during phase B2 and A2 and once
at 6 months measurement-FU, with a total of 53-64 offered measurement points.
Secondary outcome
See the METC protocol 8.1 (page 20-22) for more information about the
measurement method, instruments and assessment moments.
Severity of cluster C PD (SCID-5-PD)
To asses and evaluate change in cluster C PD severity at 6 months
measurement--FU (compared to before baseline), the Structured Clinical
Interview for DSM-5 personality disorders (SCID-5-PD; First, Williams, Benjamin
& Spitzer, 2015; Dutch translation Arntz, Kamphuis & Derks, 2017) will be
administered.
Behavioral Treatment Goals (BTG)
To asses progress in two SMART formulated Behavioral Treatment Goals (BTG)
after pre-treatment, treatment, 3 months treatment-FU and at 6 months
measurement-FU (compared to baseline), participants will score these goals on a
VAS from 0-100, with 0 referring to *goal not achieved at all*, and 100
*achieved a lot more than goal*. Participants will score their goals with the
same frequency as the ORS and NCB, with a total of 53-64 offered measurement
points.
At 6 months measurement-FU, qualitative information about participants*
experience with setting, tracking and evaluating goals will be gathered during
a 15 minutes open-question interview.
Negative Core Beliefs (NCB)
To asses change in credibility of Negative Core Beliefs (NCB) after
pre-treatment, treatment, 3 months treatment-FU and at 6 months measurement-FU
(compared to baseline), participants will rate the credibility of their two
most prominent negative core beliefs on a VAS of 0-100%, with the same
frequency as the ORS and BTG, with a total of 53-64 offered measurement points.
General mental distress (BSI)
To asses change in general mental distress after pre-treatment, treatment, 3
months treatment-FU and at 6 months measurement-FU(compared to baseline),
participants will fill in the Brief Symptom Inventory (BSI; de Beurs, 2011;
translated from Derogatis, 1975). Participants will fill this in at the
start/end of every phase, during an evaluation moment in phase B2 and at 6
months measurement-FU (in total 8 times).
Early maladaptive schemas (YSQ)
To asses change in EMS after pre-treatment, 3 months treatment-FU and at 6
months measurement-FU (compared to baseline), the Young Schema Questionnaire
(YSQ; Young & Brown, 1994; Dutch translation Sterk & Rijkeboer, 1997) is used.
Participants will fill in the YSQ 4 times (start of phases A1 and B2, at the
end of A2 and at 6 months measurement-FU).
Schema Mode (SMI-1)
To asses change in SM after pre-treatment, treatment, 3 months treatment-FU and
at 6 months measurement-FU (compared to baseline), the Schema Mode Inventory
(SMI-1; Dutch translation Lobbestael et al., 2005) is used. Participants will
fill in the SMI-1 four times (start of phases A1 and B2, at the end of A2 and
at 6 months measurement-FU).
Experiences of participants with the experiential techniques (4 Q diary)
To gain insight in the experience of participants with the experiential
techniques, participants will rate four questions (4 Q diary) on a 0-100 VAS (0
= *very little* and 100 = *a lot*) after each session (phases B1, B2 and A2).
The questions are:
1. Did the exercise/theme provide you with new insight?
2. Do you think that the exercise/theme will contribute to your recovery?
3. Are you satisfied with the exercise/theme?
4. Open question: Do you have any additional remarks on your experience with
the exercise/theme or the session?
At 6 months measurement-FU, additional qualitative information about
participants* experience will be gathered during the 15 minutes open-question
interview mentioned by BTG.
Background summary
See 'METC onderzoeksprotocol chapter 1 (introduction, pages 8-10) for more
information.
Cluster C Personality Disorders (PD) are the most frequently diagnosed PD, and
are associated with severe impairments in daily life, high co-morbidity and
high societal costs (Bamelis, Evers, Spinhoven & Arntz, 2014; Drago, Marogna &
Søgaard, 2016; Eurelings-Bontekoe, Verheul & Snellen, 2012; Kenniscentrum
Persoonlijkheidsstoornissen, 2016; Olsson & Dahl, 2012; Skodol et al., 2005;
Weinbrecht, Schulze, Boettcher & Renneberg, 2016). Nevertheless, cluster C PD
has received little attention for specific treatment options (Arntz in van
Vreeswijk, Broersen & Nadort, 2012; Drago et al., 2016; Kenniscentrum
Persoonlijkheidsstoornissen, 2016; Renner et al., 2013). Fortunately, recent
studies have shown that, among others, Schema Therapy (ST) is a promising
psychotherapeutic intervention for mixed PD and cluster C PD*s. Duration of ST
treatment differed largely among these studies, with the total session amount
ranging between 20 and 65 sessions (Renner, et al, 2013; Renner et al., 2016;
Skewes, Samson, Simpson & van Vreeswijk, 2015; Van Vreeswijk et al., 2012;
Videler, et al., 2014; Videler, et al., 2017; Weertman & Arntz, 2007).
Meanwhile, the need for effective shorter treatment options is growing in both
patients and society ( (Olsson & Dahl, 2012; Skodol et al., 2005; (van
Vreeswijk & Broersen, 2017). Although the common tenet is that PD*s are
difficult to treat and requires long and intensive treatment (Skewes, Samson,
Simpson & van Vreeswijk, 2015), a few studies showed that even short-term
protocolled cognitive schema group therapy (20 sessions) achieved improvement
in overall symptoms, overall wellbeing, EMS, SM, depression and PD severity
(Renner et al, 2013; Skewes, Samson, Simpson & van Vreeswijk, 2015; Van
Vreeswijk et al., 2012; Videler et al., 2014). These results of short-term ST
are promising, but need to be extended.
Also, the effective components of ST are still largely unknown (Arntz, 2016;
Nordahl & Nysaeter, 2005). More insight in the effects of, and experiences
with, specific techniques on their own increases the possibility to tailor
treatment to a more optimum level (Arntz, 2016; Weinbrecht et al., 2016; Renner
et al., 2016).
Experiential techniques provide tools to reach and change underlying
(repressed) emotions and longings, which are generally seen as less sensitive
to cognitive techniques (Arntz, 2016; Artnz, 2012; Muste, 2016; Videler, 2016;
Young, 2003). Since patients with cluster C PD are inclined to put up a wall
and have the tendency to block underlying emotions and longings (e.g. avoidant
or controlling coping strategies) (Artnz, 2012; Muste, 2016), experiential
techniques are expected to be specifically potent at achieving (long-term)
improvement in pathology.
As a result, the aim of this non-concurrent Single Case Experimental Design
(SCED) study is to investigate the effect of a short-term experiential ST
protocol in individual adult outpatients with cluster C PD on overall
wellbeing. Secondary outcomes are attainment of behavioral treatment goals,
credibility of negative core beliefs, global symptomatic distress, cluster C PD
severity, Early Maladaptive Schemas (EMS), and Schema Modes (SM). In addition,
satisfaction of patients with the different experiential techniques and their
experience with the techniques in relation to increase in insight and recovery
will be explored.
Study objective
Primary Objective:
To determine whether short-term experiential ST improves overall wellbeing in
adult out-patients with cluster C PD, directly after treatment, at 3 months
treatment follow-up (treatment-FU), and at 6 month measurement-FU.
6 months measurement-FU is defined as a measurement moment 6 months after
completion of the active treatment phase (B2) and thus 3 months after
completion of the treatment-FU (A2). This is due to the evaluative nature of
the treatment-FU sessions. No active interventions are performed during this
phase, thus it is not seen as active treatment.
Secondary Objectives:
- To investigate the impact of short-term experiential ST on attainment of
behavioral treatment goals, credibility of negative core beliefs, and global
symptomatic distress, directly after (pre)treatment, at 3 months treatment-FU
and at six months measurement-FU.
- To investigate the impact of short-term experiential ST on EMS and SM at 3
months treatment-FU and at 6 months measurement-FU.
- To determine the impact of short-term experiential ST on cluster C PD
severity at 6 months measurement-FU.
- To gain qualitative insight in the experience of patients with the different
experiential techniques. In specific, satisfaction with the different
experiential techniques and experience with the techniques in relation to
increase in insight and recovery will be explored.
Study design
A non-concurrent randomized multiple baseline single case experimental design
consisting of 4 phases (A1-B1-B2-A2), with a 6 months follow-up measurement
moment. Primary outcome (ORS) and two secondary outcomes (BTG and NCB) are
assessed frequently, with a total of 53-64 measurement points.
Intervention
See the METC protocol 5.1 (page 16-17) for more information.
Pre-treatment (B1)
In line with general guidelines and the used protocol in this study (e.g.
short-term schema therapy, experiential techniques by Broersen and Van
Vreeswijk, 2017), a pre-treatment phase is included. The aim of this phase is
to increase insight, develop a therapeutic relationship and increase motivation
to work on their EMS and SM in the following phase. No active ST interventions
aimed at changing pathology are conducted. Therefore, it is seen as a (second)
*attention* control phase (in line with the study of Renner and colleagues
(2006). This phase comprises 5 sessions. Sessions are held on a weekly basis,
with a duration of approximately 45-60 minutes per session.
Treatment phase (B2)
The treatment phase consists of 18 experiential ST sessions as written in the
protocol *short-term schema therapy, experiential techniques* of Broersen and
Van Vreeswijk (2017). Session 1 through 15 are held on a weekly basis, with a
duration of approximately 45-60 minutes per session. In line with the normal
procedure to spread out sessions over several weeks when treatment progresses,
session 16, 17 and 18 are held once every two weeks.
Treatment-FU phase (A2)
Following protocol, the treatment follow-up phase (A2) consists of 2 sessions
with a duration of approximately 45-60 minutes per session, respectively 1
month and 3 months after the end of phase B2. These sessions are purely
evaluative. No ST interventions are offered.
Every session outlined in the protocol will take place in the same order for
every participant and no sessions are skipped. In the event of a cancelled
session, weekly measurements continue irrespective of session planning.
Study burden and risks
See the METC protocol 11.4 (page 30) for more information.
Extra time burden related to participating in the study is approximately 3.5 up
until maximum 5.5 hours and some participants will have to wait a bit longer
than others as a result of randomization (although waiting time is still in
line with normal procedures).
Also, filling in questionnaires and undergoing SCID-5-PD interview can be
confrontational. However, most of the used measurements are standard and
applied frequently in Dutch health care (exceptions being the BTG, NCB and 4 Q
diary). To the knowledge of the researcher, no serious adverse events have been
documented related to filling in the used questionnaires or to VAS-scoring (as
used for the BTG, NCB and 4 Q diary). Moreover, scoring BTG and monitoring
therapy progress could be considered a motivational factor in working on
goals/practicing new adaptive behavior (Turner-Stokes, 2018).
Participants are assumed to receive state of the art treatment. It is expected
that participants will benefit from the treatment. Results are accessible to
participants and a final feedback session is offered wherein the final
measurement outcomes are discussed, contributing to their insight in the change
of their pathology. Participants receive a gift card of 10 euros for
participating, the workbook is complimentary, and extra travel expenses will be
fully compensated. No major disadvantages or adverse events have been
documented before and are not expected.
Kiekendiefstraat 19
Den Haag 2496 RP
NL
Kiekendiefstraat 19
Den Haag 2496 RP
NL
Listed location countries
Age
Inclusion criteria
(1) Principal diagnosis of a DSM-5 cluster C PD (e.g. avoidant, obsessive-compulsive and/or dependent PD), determined by a structured interview (SCID-5-PD)
(2) Age between 18 and 65 years
(3) Possession of a smartphone, laptop or a desktop computer
(4) Written informed consent, including consent to audiotape the sessions
(5) Ability to read, write and speak the Dutch language
Exclusion criteria
(1) Non-detoxified alcohol- or drugs dependence (inclusion is possible after detoxification)
(2) Full diagnosis of comorbid DSM-5 cluster A or B PD determined by a structured interview (SCID-5-P)
(3) Level of education lower than preparatory secondary vocational education
(4) Experience with ST in the past year
(5) Following other psychological treatments during the study. Pharmacotherapy is allowed as a co-intervention if it was already started before participating in the study. It is protocol that medication (dose) will not be changed during participation in this study, except when a crisis situation requires deviation from protocol (see chapter 9 AEs, SAEs). Participation in the study will end if dosages are changed
(6) High suicide risk as determined by the treating therapist (suicide taxation when suicidal ideations are present)
(7) A (history of) psychotic or bipolar 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
In other registers
Register | ID |
---|---|
CCMO | NL65135.078.18 |
OMON | NL-OMON26352 |