The aim of the current study is to 1) investigate what the effects are of a condensed, intensive outpatient exposure treatment in patients with OCD who are not sufficiently improved from standard CBT (ERP) and 2) to map early indicators regarding…
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Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to investigate the effects of condensed,
intensive ambulatory exposure treatment in patients with OCD, as step 2 in the
treatment process, who have not improved sufficiently with standard,
protocolled CBT (ERP) as step 1. It is hypothesized that patients with
insufficient response after standard treatment will benefit from
intensification of treatment (Y-BOCS-SR < 12 and/or improvement percentage
Y-BOCS-SR > 35%).
Secondary outcome
A second objective of this study is to map early indicators of treatment
outcome. The hypothesis is that early indicators of insufficient response
during standard CBT treatment can be identified. Early indicators to consider
are: difficulty performing the exposure tasks, sleep problems, depressed mood,
and excessive worrying
Background summary
The obsessive compulsive disorder is an invalidating disorder that can disrupt
the quality of life severely. If the disorder stays untreated, it can take a
chronic nature. According to the multidisciplinary guidelines, cognitive
behavioural therapy (CBT) with exposure and responseprevention is the first
choice of therapy. Nevertheless, only 50% of people receiving this treatment
benefit from it at end of treatment or follow up. There has been experimented
with intensification of treatment internationally with a positive effect.
However, in these studies it is not clear what kind of treatment the clients
actually had prior to the study. This is mainly based on a description of the
client. The current study aims to follow the state of the art CBT and, when
there is not a significant response, to insert a intensive treatment as a
stepped care method. Another aim is to try to map early indicators of non
response during the first treatment proces and to improve the stepped care.
Study objective
The aim of the current study is to 1) investigate what the effects are of a
condensed, intensive outpatient exposure treatment in patients with OCD who are
not sufficiently improved from standard CBT (ERP) and 2) to map early
indicators regarding treatment outcome. De power of this study lies in the
process of following both treatment phases from beginning tot end instead of
relying on a description of the client.
Study design
In this study two treatment methods are used as a stepped care model and the
study investigates if non response after step 1 standard CBT will significantly
improve after intensive treatment. The design of this study will be a single
case series design A-B-C-D.
Phase A: Baseline (phase A) will be a period of two weeks prior to start of
treatment.
Phase B: After baseline the participant will start with standard CBT at HSK
Groep where they will receive 20 sessions.
Phase C: If the patient will not improve significantly, they will be referred
to the intensive FOCUS treatment at Overwaal, Pro Persona.
Phase D: After end of treatment there will be a 3 month follow up.
All participants will receive the same intervention. By measuring the symptoms
over time on a daily and weekly base, the causal relationship between the
intervention and treatment result can be defined. The duration of this study
will be 31 weeks plus a follow up 3 months later.
The Y-BOCS-SR will be send to the participant on a weekly base to fill in. This
questionnaire will be filled in during phase A to C. During follow up this
questionnaire will be filled in once.
In addition, during phase A to C participants will fill in a daily
questionnaire of 2-3 minutes. The Experience Sampling Method will be used. This
questionnaire aims to measure the daily symptoms and to analyze if there are
signs of early indicators that can predict non response in phase B.
There will be nine moments during the study where additional questionnaires
will be filled in, namely the SQ-48 en QIDS-SR. At T8, the evaluation
questionnaire will be sent as a standard part after completion of the
treatment.
Intervention
The intervention will consist of 20 standard CBT sessions in an outpatient
setting at HSK Groep where, if the response is insufficient, the treatment will
be followed by an intensive FOCUS treatment at Overwaal, Pro Persona.
The treatment at HSK Groep follows the CBT protocol of Verbraak et al. (2017)
with an emphasis on ERP. In the treatment phase, clients are seen weekly and
family members are preferably involved in the treatment.
The FOCUS treatment takes place in an outpatient setting at Overwaal, Pro
Persona. The treatment there lasts a total of 11 weeks, with an initial
consultation taking place. The client is then invited for a preparation day.
The program will start two weeks after this day. The first two weeks of the
program consist of eight full days of treatment with half days at the facility
and half days at home or in other contexts from the clients life. This is
followed by four 90-minute booster sessions that take place once a week. A week
later, the program ends with an evaluation session. At least one family member
or close friend is expected to attend two 90-minute morning blocks during the
eight intensive days. They receive psycho-education about the OCD, how they can
possibly facilitate this OCD and how they can stop it. In addition, they are
invited to a booster session. The client is also asked to bring a coach with
them during the booster sessions with whom they can sit together after the
treatment to see how they can persevere. This coach can be someone from their
environment, but not the partner or parent.
Study burden and risks
The load consists of completing questionnaires on a daily and weekly basis. The
sessions will take place weekly in phase B and in phase C the treatment will
contain an intensive part of two weeks during which one must be available for
eight full days.
Polanerbaan 3
Woerden 3447GN
NL
Polanerbaan 3
Woerden 3447GN
NL
Listed location countries
Age
Inclusion criteria
Participants have a current primary classification of obsessive compulsive
disorderd according to the DSM-5, assessed with the DSI.
Participants have a Y-BOCS score of 16 or higher
Participants have a SQ-48 score higher than 37
Participants have an age between 18-64 years
Participants are able to speak the Dutch language on a sufficient level
Exclusion criteria
- Presence of severe developmental disorders
- Severe suicidality
- Presence of a acute psychotic disorder
- Presence of a disorder that interferes with OCD
- Personalitytraits or disorders that need treatment first
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 | NL84925.091.23 |