Objective: The primary aim of the present study is to investigate the effectiveness of MBCT in a group format versus TAU in a group format for treatment refractory anxiety disorders Furthermore; we will investigate mediators associated with…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998a,
1998b). The MINI+ will be used to obtain DSM-IV diagnoses. The validation of
the Dutch translation of the clinician rated (CR) version of the MINI (van
Vliet & de Beurs, 2007) against the Structured Clinical Interview
DSM-III-R-patient version (SCID-P) and the Composite International Diagnostic
Interview for ICD-10 (CIDI) showed good to very good kappa values (Sheehan et
al., 1998b).
• Beck Anxiety Inventory (BAI) (Beck, Epstein, Brown, & Steer, 1988). The BAI
is a self-report questionnaire which consists of 21 items, each describing a
common symptom of anxiety over the past week on a 4-point likert scale ranging
from 0 to 3 (total score is 63). The scale has good internal consistency (0.92)
and convergent validity (0.51) and discriminates between depression and
anxiety. Test-retest reliability also appeared to be sufficient (0.75). The BAI
will be used as primary outcome measure.
Secondary outcome
• Fear Questionnaire (FQ) (Marks & Matthews, 1979). This self-report
questionnaire consists of 3 subscales (agoraphobia, social phobia and
blood/injury dimensions). Besides these subscales the FQ also incorporates one
scale assessing severity of avoidance behavior, how troublesome and
disturbing/disabling the present symptoms are according to the patient. A Dutch
validation study showed that all scales have sufficient internal consistency
and convergent and discriminate validity (van Zuuren, 1988).
• Beck Depression Inventory-II (BDI-II) (Beck, Erbaugh, Ward, Mock, &
Mendelsohn, 1961; Beck, Steer, Ball, & Ranieri, 1996). The BDI is a self-report
questionnaire and consists of 21 items (rated 0 to 3), each describing a
depressive symptom in four levels of severity. Total scores range from 0 to 63.
The BDI-II has high internal consistency with a Cronbach*s alpha of .91 (Beck
et al., 1996; van der Does, 2002).
• World Health Organization Quality of Life - Bref (WHOQOL-Bref) (Trompenaars,
Masthoff, Van-Heck, Hodiamont, & De-Vries, 2005). The WHOQOL-Bref was developed
as an international cross-culturally comparable self-report quality of life
assessment instrument. It assesses the individual's perceptions of quality of
life in the context of their culture and value systems, personal goals,
standards and concerns across 4 domains: physical health, psychological health,
social relationships, and environment. The internal consistency of the four
domains of the WHOQOL-Bref ranged from 0.66 to 0.80. Domain scores of the
WHOQOL-Bref correlated around 0.92 with the WHOQOL-100 domain scores.
Relatively low correlations were found between demographic characteristics (age
and sex) and WHOQOL-Bref domain scores. It is concluded that the content
validity, construct validity, and the reliability of the WHOQOL-Bref in a
population of adult Dutch psychiatric outpatients are good (Trompenaars et al.,
2005).
Mechanisms of change:
• Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004): The
DERS is a 36-items self-report questionnaire consisting of 6 subscales: 1)
Non-acceptance of emotional responses (6 items); 2) Difficulties engaging in
goal-directed behavior (5 items); 3) Impulse control difficulties (6 items); 4)
Lack of emotional awareness (6 items); 5) Limited access to emotion regulation
strategies (8 items); 6) Lack of emotional clarity (5 items). The internal
consistency for the total scale as well as for the subscales appeared to be
adequate (varying between a Cronbach*s alpha of 0.80 and 0.93). The
questionnaire also has adequate construct and predictive validity and good
test-retest reliability.
• Five Facet Mindfulness Questionnaire (FFMQ) (Bear, Smith, Hopkins,
Krietemeyer, & Toney, 2006). This 39 item questionnaire assesses five core
dimensions of mindfulness on a 5 point likert scale, including observing (8
items), describing (8 items), acting with awareness (8 items), non-judging (8
items) and non-reacting (7 items).validity and reliability have been tested and
are good. The FFMQ has been translated and validated in Dutch by Muskens and
Kamphuis, publication of these results is expected in 2011.
• Penn State Worry Questionnaire (PSWQ): This self-report questionnaire
assesses the general tendency to worry (Meyer, Miller, Metzger, & Borkovec,
1990; Van Rijsoort, Emmelkamp, & Vervaeke, 1999). The PSWQ is a 16-item
inventory designed to capture the generality, excessiveness, and
uncontrollability of pathological worry. It has been shown to have good
internal consistency with samples consisting of older adults with GAD (Beck,
Stanley, & Zebb, 1995), community subjects (Brown et al., 1992), and
undergraduates (Meyer et al., 1990). It has also demonstrated good test-retest
reliability over 8-10 weeks (Meyer et al., 1990). The PSWQ is translated and
validated for a Dutch population (van Rijsoort, Emmelkamp, & Vervaeke, 1999).
• Rumination on Sadness Scales (Conway, Csank, Holm & Blake, 2000; Raes,
Hermans & Eelen, 2003) will be used to assess the role of rumination in the
maintenance or decrease of depressive and anxiety symptoms. Psychometric
properties of the rumination on sadness scale is good (Roelofs, Muris, Huibers,
Peeters & Arntz, 2006).
• The amount of Attentional Control (AC), measured with an
Negative Affective Priming (NAP) task (Raedt, De, Baert, Demeyer, et al., 2011;
Joormann, 2004). The NAP task measures the cognitive processing of emotional
information, through which the ammount of AC can be determined. Previous
studies have shown that susceptibility towards anxiety is negatively correlated
with the amount of AC (Eysenck et al. 2007). Studies investigating AC with
depressed subjects have shown that the amount of AC increases after Mindfulness
Based Cognitive Therapy (Raedt, De, Baert, Demeyer, et al., 2011).
Questionnaires related to treatment
• Medication and other psychological treatment: At the follow-up assessment
(T4), use of medical (e.g., doctor visits, hospitalization, medication) and
psychological (e.g., psychologist or social worker visits) health services will
be recorded using cost-diaries. The total costs of these services will be
calculated according to standard prices. In addition, cost diaries will be used
to record productivity losses (e.g. sickness leave). Participants will be
trained in the use of these diaries and accurate completion of the diaries will
be carefully monitored.
Background summary
Rationale: Anxiety disorders have the highest incidence and prevalence of all
psychiatric disorders in the Netherlands and are the most economically costly,
entailing large amounts of personal suffering, use of medical and psychosocial
services, and productivity losses. Cognitive Behavioural Therapy (CBT)
sometimes complemented with a pharmacological intervention, is the treatment of
choice for the complete range of anxiety disorders. However, only 50% to 80% of
patients undergoing treatment achieve a responder status. These percentages
might even be overestimated because of selection and publication biases.
Current multidisciplinary clinical guidelines do not prescribe further
treatment options for treatment refractory patients, stressing the need for the
development and investigation of new interventions. Mindfulness based cognitive
therapy (MBCT) is innovative and research has shown that it holds promise for
patients who are difficult to treat otherwise. The current study aims to
investigate the effectiveness of MBCT compared to treatment as usual (TAU) for
patients who did not benefit from existing evidence-based treatment protocols.
If proven effective, MBCT can for instance be a second or third intervention
after CBT or an pharmacological intervention in a stepped care approach,
thereby increasing efficiency in mental health care processes.
Study objective
Objective: The primary aim of the present study is to investigate the
effectiveness of MBCT in a group format versus TAU in a group format for
treatment refractory anxiety disorders
Furthermore; we will investigate mediators associated with treatment outcome
and the predictive effects of patient variables on treatment outcome, thereby
increasing the possibilities to offer patients the most suitable treatment.
More specifically, the project tries to answer the following questions:
1. Is MCBT more effective in reducing anxious complaints compared to TAU?
2. Is improved emotion regulation associated with symptom reduction?
3. Which clinical and demographic factors are related to symptom improvement
Study design
The design of the study will be a 2 group (MBCT, TAU) randomized controlled
clinical trial with repeated measurements at baseline (T0), midtest (T1),
posttest (T2) and 6 months follow-up (T3). Patients will be screened during a
shortened intake meeting in which they will be asked to complete a short
computer task. The same computer task will be administered during debriefing.
At each assessment, symptom questionnaires, a diagnostic interview, and
emotion-regulation measures will be administered (see figure 1 for an overview
of the study). After conclusion of the experimental part of the study patients
will enter a naturalistic follow-up period in which they are allowed to seek
help the way they would normally do when confronted with an increase of anxious
symptoms (e.g., visiting one*s general practitioner or seeking sources of
symptom relief, using pharmacotherapy). Patients will be asked to report
meticulous the use of medication and psychotherapy or other forms of counseling
over the follow-up period.
The study will be performed at PsyQ (Parnassia Bavo group), a large urban
ambulatory mental health organization in the Hague at the department of anxiety
disorders.
Intervention
Mindfulness-Based Cognitive Therapy (MBCT) (Condition 1)
MBCT will be offered according to the protocol of Segal, Williams, and Teasdale
(2003). MBCT, adapted for anxiety disorders, and will be provided in 8 weekly
2-hour group sessions consisting of a maximum of 8 patients suffering from
different anxiety disorders which is in line with the transdiagnostic starting
point of MBCT. During these sessions, different skills will be taught to help
patients to become more aware and to relate differently to their anxious
thoughts, feelings, and sensations (Teasdale et al., 2000). Participants are
expected to engage in "homework" between sessions, which can consist of up to
an hour of mindfulness practice and exercises each day. Each MBCT course will
be provided by two experienced therapists who received formal MBCT training and
weekly supervision by a senior licensed psychotherapist with formal training
and extensive experience in delivering MBCT. All sessions will be audiotaped to
assess protocol adherence. The MBCT course covers the following topics. In
session 1 and 2 patients are taught to become more aware of the habitual
*automatic pilot* way in which information is processed and the distractibility
of the mind by automatic thoughts and feelings. Session 3 is devoted to how
focusing on breathing can be helpful to stay in the here-and-now. Sessions 4
and 5 focus on the counterproductive effect of avoiding and escaping negative
thoughts and feelings compared to an accepting and tolerating stance. In
session 6, patients are taught to disengage from negative thoughts by labeling
them as thoughts instead of facts. Sessions 7 and 8 focus on relapse
prevention.
Treatment as usual (TAU) (Condition 2)
Patients in the TAU condition will be offered a form of supportive
follow-up care, which is routine procedure in the current and most mental
health care programs. Follow-up care is also provided in a group consisting of
a maximum of 8 patients with a duration of 8 weeks. The format of the MBCT and
TAU group will be similar to a large extent to decrease the role of confounding
non-specific factors, like participating in structured group therapy. In
follow-up care, problems encountered in daily life and coping strategies can be
discussed. Patients are asked to complete individual homework assignments
between session (for example to practice new coping skills and engage in daily
activities). Follow-up care is given by experienced cognitive behavioral
therapists.
Study burden and risks
There are no risks associated with the present study. The only inconvenience
for participating subjects could be that they have to fill in questionnaires 4
times during the study which will take approximately 2 hours the first time
(screening) and 1 hour the following 3 times. Furthermore, patients have to be
willing to adhere to the inclusion criteria during the active treatment phase.
In case of serious adverse events deviation of the protocol is allowed. Except
for therapeutic effects there will be no direct advantages associated with
participation. In general the study will lead to more knowledge of effective
treatments for anxiety disorders and a proposal for stepped care will be
developed.
Lijnbaan 4
Den Haag 2512 VA
NL
Lijnbaan 4
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
- still fullfilling the criteria for an DSM IV axis 1 anxiety disorder
- refrain from treatment and counseling more frequently than once a month during the intervention
- stable use of anti-depressant medication or Benzodiazepines at leatst 3 months before inclusion
- Willingness to keep the dosage on a constant level during the intervention
For MBCT:
-willingness to complete daily homework assignments between sessions during the MBCT course.
Exclusion criteria
Primary axis 1 diagnosis of substance abuse or dependence, suicidality or psychotic symptoms
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL38961.058.12 |