The efficacy of Inquiry Based Stress Reduction (IBSR) for depression,
a randomized clinical trial.

Background (see the research proposal in the appendix for a list of cited
articles)
Depression is a serious illness. In the Netherlands 18.7% of the population
experiences an episode of depression in their lifetime and each year 5.2% of
the Dutch population suffers from a depressive disorder (de Graaf, ten Have, &
van Dorsselaer, 2010). About half of all patients have episodes that last
shorter than 3 months (Spijker, et al. 2002). For up to one-third of all
patients that period is longer than 2 years (Keller, 2001). In 15-20% of all
cases patients develop a chronic depression (Eaton, 2008). In the Netherlands
58.5% of patients with a clinical depression receive health care (GGZ
Nederland, 2013). The annual costs in the Netherlands are almost 3 billion of
which a third are cost for the treatment of depression (Slobbe, Smit, Groen,
Poos, & Kommer, 2011; de Graaf, Tuithof, Dorsselaer, & ten Have, 2011). The
costs of depression in the Netherlands in 2011 were calculated to be 164.000
Disability Adjusted Life Years (DALY's; Poos, Gool, & Gommer, 2014). Using the
DALY, unipolar major depression was the third leading burden of disease
worldwide in 2004 and the World Health Organisation estimated that it will be
the leading cause of disease burden worldwide by 2030 (Lépine & Briley, 2011).

Psychotherapeutic interventions
Of the psychotherapeutic interventions for depression the most researched and
empirically validated are cognitive behavioural therapy (CBT) and Interpersonal
psychotherapy (IPT; Cuijpers, van Straten, Andersson, & van Oppen, 2008;
Lemmens et al., 2011, Cuijpers et al., 2011). Both psychotherapies are
empirically-supported psychological therapies for the treatment of patients
with a mood disorder (EST's; Hollon & Ponniah, 2010). Cuijpers, et al. (2013)
calculated the effect size of CBT for depression based on 115 RCT studies and
found (after correction for possible publication bias, for which they found
strong indications) a g of 0.53. Another way of reviewing the effects of CBT
for depression is looking at remission rates. Schindler, Hiller, and Witthöft
(2011) found in a sample of 338 depressive patients treated with CBT in an
university outpatient clinic that 48% remitted and 5.7% deteriorated. When
restricted using the Reliable Change Index (RCI; Jacobson & Truax, 1991) as
described by Seggar, Lambert, and Hansen (2002) the remission rate dropped to
43.2% and 3.2% deteriorated. Gibbons et al. (2010) found that 61% of their
outpatient sample of 217 depressed patients improved and 8% deteriorated
significantly using CBT. The recovery rate was 45% using RCI as described by
Jacobson and Truax (1991) when only those patient were included that scored
above the cutoff before treatment (36% of the complete sample). Reaching
remission is important, because patients not reaching full remission are 5
times more likely to relapse than fully remitted patients (Judd et al., 2000),
which increases costs.
A significant number of depressive patients treated with CBT who reach
remission or recovery show relapse or recurrence of the depression. Vittengl,
Clark, Dunn, and Jarrett (2007) performed a meta-analysis and found that the
relapse/recurrence rate in patients treated in the acute phase (with the goal
of reducing depressive symptoms and producing initial remission) was 29% within
the first year and 54% within two years. After continuation phase treatment was
added (treatment applied to sustain remission and reduce the probability of
relapse/recurrence) the average relapse percentage was between 10 and 12% at
post-treatment and between 40 and 42% at follow-up (average duration between
114 and 153 weeks). The numbers above show that CBT treatment is good, but
insufficient in terms of remission and relapse. There is need for better
treatments or improvement of existing treatments. In this research project we
will test the efficacy of a relatively new and promising treatment method,
Inquiry Based Stress Reduction.

Inquiry Based Stress Reduction (IBSR), an introduction
IBSR is a psychological treatment method, focusing on a structured process of
self-inquiry. It is considered as a way of identifying and investigating one's
thoughts in order to alleviate suffering. IBSR is a process developed in 1986
by Byron Katie (Katie, 2002). The main premise is that the only time that
people suffer emotionally is when they believe a thought that argues with
reality. The method contains a structured way of identifying and inquiring
thoughts. Inquiry is done by asking four questions and turning a thought around
to opposite statements (a broader explanation is done in the theoretical
background section). IBSR has been practiced by people in more than 30
countries (www.thework.com). Katie trained thousands of people in IBSR through
her school. The IBSR method is estimated to be used by hundreds of
psychologists in the Dutch Health care system (derived from the number of
psychologists trained by van Rhijn, the fourth author). The Dutch Association
of Behavioural Therapy and Cognitive Therapy (VGCt) allows students to make use
of IBSR-courses in their training to become a registered cognitive behavioural
therapist. Other specialized psychological associations, such as the Federation
of Health Psychologists (FGzP), the Dutch Association of Psychologists (NIP)
and the Association of Educationalists in the Netherlands (NVO), allow
IBSR-courses to be used for recertification purposes.
IBSR has been proven to reduce a range of psychological symptoms,
including depressive symptoms (Nye, 2011; Gaanderse, 2011; Leufke, Zilcha-Mano,
Feld, & Lev-ari, 2013, Lev-ari, Zilcha-Mano, Rivo, Geva, & Ron, 2013; Smernoff,
Mitnik, & Lev-ari, in press). The effects of IBSR are assessed using studies
with a waiting list control group (Nye, 2011; Lev-ari & Arber, 2014) as well as
in a study which used a waiting list control group and a group which received
an alternative intervention (Gaanderse, 2011). IBSR is a promising treatment
method. We stress the need for a well powered randomized clinical trial (RCT)
to test the efficacy of IBSR in a sample of depressed patients. We want that
depressive patients have the opportunity to gain from the best possible
treatment. In line with the guidelines described by Chambless and Ollendick
(2001) we will test the effectiveness of IBSR in comparison with an EST. In
this RCT we choose CBT instead of IPT as control treatment for IBSR, given our
work setting. CBT is the most common therapy our colleagues are trained in and
work with. This has an additional advantage because we will be able to do a
mediation analysis to test the presumed underlying working mechanisms of IBSR
and CBT and the presumed difference between both methods.

Emotion, cognitive change and voice acoustics
There is evidence that dysfunctional attitudes in depression are mood-state
dependent (Segal, Kennedy, Gemar, Hood, Pedersen & Buis, 2006). In other words,
a sad mood triggers dysfunctional attitudes which triggers a depressive
response. Therefore it is plausible that in order to change dysfunctional
attitudes during psychotherapy, these attitudes need to be accessible by
experiencing the triggering emotions during the therapy sessions. A method to
examine different emotional states is by analysing the paralinguistic aspects
of speech. Emotional states such as fear, anger, or sadness activate the stress
system and influence muscle tones. Vocalisation is a product of different
muscle tones in the chest and the throat which influence different kinds of
paralingual aspects of speech, for instance pitch, pitch range, pitch
variability, loudness and rate of speech (Darby, 1981; Scherer 1986).

This research project is a collaboration between FortaGroep and the Erasmus
University Rotterdam. We want to assess the effects of IBSR and CBT on
depressive (and other psychological) symptoms in a sample of 88 depressive
patients, on short and longer term. Furthermore, we will investigate the
underlying mechanisms of change of IBSR and CBT for depression and test their
specificity. The treatments will be performed between 2015 and 2018. Experts in
the field of IBSR treatment for depression and CBT treatment for depression are
involved in the project. This unique collaboration of psychologists and
researchers aims to perform high quality research according to international
standards. If IBSR for depression is proven to be superior to CBT treatment, we
will actively share the information on IBSR to make the therapy available for
depressive patients all over the Netherlands. A better treatment, which results
in larger symptom reduction, decreases symptoms in more patients and is better
in preventing relapse, will increase wellbeing for a substantial proportion of
the Dutch society.



Main questions
Is IBSR an effective intervention for outpatients suffering depression compared
to treatment as usual (CBT) in reducing depressive symptoms measured by the
BDI-II-NL, on short term (post-treatment)? And on long term (after 1 and 2
years)?

Hypothesis
Main hypothesis
In treating an outpatient sample of depressive patients IBSR in relation to CBT
is:
more effective in reducing depressive symptoms (between pre-treatment and
post-treatment/follow-up)
more effective in preventing relapse (measured with the BDI-II-NL using the RCI)
more effective in reaching absence of clinical depression (between
pre-treatment and post-treatment)

There is a relation between baseline measures of paralingual aspects of speech
(pitch, pitch variability and speech rate) and depression severity as measured
with the BDI-II-NL.
Paralingual aspects of speech (pitch, pitch variability and speech rate) change
over the course of psychotherapy.
Changes in paralingual aspects of speech during the course of psychotherapy are
associated with diminishing in depressive severity
There is a difference between CBT and IBSR in eliciting emotions as measured by
paralingual aspects of speech (pitch, pitch variability and speech rate) and
these differences are related to the diminishing of depression severity as
measured with the BDI-II-NL.
The amount of emotions of the therapist are related to therapy outcome
There is a relation between the emotional responses (as measured by pitch,
pitch variability and speech rate) of the therapist and therapy outcome.

The primary goal of this research project is to improve mental healthcare for
patient suffering depression in the Netherlands as well as in other countries.
The outcomes can help increase the quality of life for a large group of people
and it can decrease costs for mental healthcare and reduce the indirect costs
of depression. In this research project we want to assess the effectiveness of
a relatively new and promising treatment, IBSR.

Main questions
Is IBSR an effective intervention for outpatients suffering depression compared
to treatment as usual (CBT) in reducing depressive symptoms measured by the
BDI-II-NL, on short term (post-treatment)? And on long term (after 1 and 2
years)?

Main hypothesis
In treating an outpatient sample of depressive patients IBSR in relation to CBT
is:
more effective in reducing depressive symptoms (between pre-treatment and
post-treatment/follow-up)
more effective in preventing relapse (measured with the BDI-II-NL using the RCI)
more effective in reaching absence of clinical depression (between
pre-treatment and post-treatment)

An important subquestion for us is:*
Is the underlying mechanism in IBSR different from CBT?

Our sybhypothesis to this question are:
The underlying mechanism in IBSR is different from CBT
A decrease in depressive symptoms in the IBSR-group is mediated by an increase
in acceptance.
A decrease in depressive symptoms in the CBT-group is mediated by a decrease in
dysfunctional attitudes.
*more subquestions and hypothesis can be found in the research proposal in the
appendix

There is a relation between baseline measures of paralingual aspects of speech
(pitch, pitch variability and speech rate) and depression severity as measured
with the BDI-II-NL.
Paralingual aspects of speech (pitch, pitch variability and speech rate) change
over the course of psychotherapy.
Changes in paralingual aspects of speech during the course of psychotherapy are
associated with diminishing in depressive severity
There is a difference between CBT and IBSR in eliciting emotions as measured by
paralingual aspects of speech (pitch, pitch variability and speech rate) and
these differences are related to the diminishing of depression severity as
measured with the BDI-II-NL.
The amount of emotions of the therapist are related to therapy outcome
There is a relation between the emotional responses (as measured by pitch,
pitch variability and speech rate) of the therapist and therapy outcome.

To asses our research questions in the best possible manner we chose to set up
a randomized clinical trial (RCT). This design (RCT) is not only the standard
for the evaluation of effectiveness of psychiatric treatments (Schulz, 2010),
but is also very valuable in studying mechanisms of therapeutic change (Haaga &
Stiles, 2000; Nock, 2007). Because we will assess the effects of IBSR in
relation to an effective treatment, CBT, we expect a small to medium effect
size.

The intervention in the experimental group is IBSR. In the control group the
intervention is treatment as usual, CBT.

The IBSR intervention consists of psycho-education on depression and the
influence of thought on how we feel. After that dysfunctional thoughts are
identified in a structural manner. The next step is to inquiry those thoughts
using a structured protocolized set of questions and turning a thought around
to opposite statements (see the research proposal in the appendix for a broader
explanation). The worksheet that are used can be found in the appendix.
Participant will perform homework assignments which mainly consist of inquiring
thoughts. During the endfase of the treatment a plan for the future will be
made which consists of the discoveries the participant made during the
treatment. This is for the purpose of relapse prevention.

Participants will have two intake appointments with tho different psychologists
and a treatment of 16 sessions. The treatment can be shorter (the data of a
participant will be included when he receives at least 5 therapy sessions and
the termination of the treatment is in accordance with therapist advice). The
burden of having two intake appointments and the treatment sessions is
identical to the current procedure when someone is referred with a depressive
disorder.

Participant however will have an extra burden when participating, such as the
administration of the SCID-I during the intake phase and the filling of
additional questionnaires. During standard procedure Routine Outcome
Measurements (ROM's) are performed using the SQ-48 (48 multiple choice items)
at intake, evaluation and the end of the treatment. The questionnaire specific
to this research project which administration is 'extra' are the BDI-II-NL (21
multiple choice items), the SF-36 (36 multiple choice items), the ZBV (40
multiple choice items), the AAQ (10 multiple choice items) and the DAS (17
multiple choice items).
The SCID-I, the SF-36 and the ZBV are administered at intake, post-treatment
and at the follow-ups after 1 and 2 years. The BDI-II-NL, the AAQ and the DAS
are administered at intake, the 4th session, the 8th session, the 12th session,
post-treatment and at the follow-ups after 1 and 2 years.

There is no indication of higher risks because of this research project. Both
treatments are currently in use for treating patients with a depression.
Earlier research showed no indications for hinger risks. All sessions are with
professional psychologists (who receive supervision). In case symptoms rise or
there is a crisis situation (such as when a patient becomes suicidal of there
is another serious disturbance which obstructs treatment in accordance with the
treatment protocol) dropout will take place and adequate care will be provided.
It is possible that participants receive suboptimal treatment when the
experimental treatment is inferior to the standard treatment. On the other
hand, there is the possibility that they, in accordance with our expectations,
will receive a better treatment and that they will be the first to profit from
the 'new' treatment.