The present study is aimed to study the feasibility and effects of ICBT for outpatient nonresponding CBT patients with PD or OCD.Primary Objective: 1. Is this treatment model effective in terms of reduction in PD or OCD symptoms?Secondary Objective(…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are:
Adults:
PDSS for PD
The main PD symptoms are assessed with the PDSS: The Panic Disorder Severity
Scale
(Shear, et al., 1992; de Beurs, 2002). The PDSS is a 7 item semi-structured
clinical interview. Symptoms of the last week are rated on a 5-points Likert
scale, ranging from 0-4. The most important aspects of panic disorder (panic
frequency, fear or distress during panic attacks, anticipatory anxiety, phobic
avoidance of situations, phobic avoidance of physical sensations, impairment in
work and social functioning.
The (clinician-administered) PDSS is considered a reliable tool for monitoring
of treatment outcome (Shear, et al., 2001).
The scale can be administered in 10-15 minutes.
Y-BOCS for OCD
The main OCD symptoms are assessed with the Y-BOCS: the Yale-Brown
Obsessive-Compulsive Scale (1989). The Y-BOCS is a 10-item semi-structured
clinical interview. Symptoms of the last week are rated on a 5-points Likert
scale, ranging from 0-4. The (clinician-administered) Y-BOCS is considered a
reliable tool for monitoring of treatment outcome and is considered as the gold
standard measure of obsessive-compulsive symptoms (Storch et al., 2005).
The scale can be assessed in 15-30 minutes.
Adolescents:
CY-BOCS for OCD
The main OCD symptoms are assessed with the CY-BOCS: the Child Yale-Brown
Obsessive-Compulsive Scale (Scahill et al., 1997; de Haan & Wolters, 2007). The
CY-BOCS is a 10-item semi-structured clinical interview. Symptoms of the last
week are rated on a 5-points Likert scale, ranging from 0-4. The
(clinician-administered) CY-BOCS is considered a reliable tool for monitoring
of treatment outcome and is considered as the gold standard measure of
obsessive-compulsive symptoms (Storch et al., 2005).
The scale can be assessed in 15-30 minutes.
Secondary outcome
Adults:
IDS
Depressive symptoms are assessed with the IDS: Inventory of Depressive
Symptomatology (Rush et al., 2000). The IDS contains 30 items with a 4-point
Likert Scale. In the present study the Self Rating version is used. The IDS has
good validation (Rush et al., 1996).
The scale can be assessed in 10 minutes.
OQ
The Outcome Questionnaire (OQ-45.2) is a 45-item self-report scale designed
for repeated measurement of client functioning through the course of therapy
and at termination. The instrument has proven particularly useful in
documenting the effect of interventions due to therapy as it has been shown to
be sensitive to change in a treated population while remaining stable in a
nontreated population (Lambert, Burlingame, et al., 1996).
MINI
The Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998;
Overbeek et al., 1999) is a short diagnostic structured interview (DSI)
developed in France and the United States to explore 17 disorders according to
Diagnostic and Statistical Manual (DSM)-III-R diagnostic criteria (Sheehan et
al., 1998; Overbeek, 2006) . It is fully structured to allow administration by
non-specialized interviewers.MINI is a short diagnostic interview schedule that
can be easily incorporated into routine clinical interviews. It has good
acceptance by patients (Pinninti et al., 2003). In order to keep it short it
focuses on the existence of current disorders. For each disorder, one or two
screening questions rule out the diagnosis when answered negatively.
CGI
The Clinical Global Impression Scale (CGI; Guy, 1976) is a 3-item questionnaire
designed to assess global severity of illness and change in the clinical
condition over time. The CGI consists of three global scales: 1) severity of
illness; 2) global improvement; 3) efficacy index. The clinical Global
Impression Scale (CGI) is commonly used as a primary outcome measure in studies
evaluating the efficacy of treatments for anxiety disorders (Zaider et al.,
2003).
EQ-5 D
The EQ-5D (EuroQol, group, 1995) is a generic questionnaire which generates a
health profile as well as index scores for health-related quality of life that
may be used in cost-utility analysis. König et al (2010) examined validity and
responsiveness of the EQ-5D in patients with anxiety disorders.
The EQ-5D questionnaire comprises five questions (items) relating to current
problems in the dimensions' mobility', 'self-care', 'usual activities',
'pain/discomfort', and 'anxiety/depression' [2,3,16]. Responses in each
dimension are divided into three ordinal levels coded (1) no problems, (2)
moderate problems, (3) extreme problems. This part, called the EQ-5D
descriptive system, provides a five-dimensional description of health status
which can be defined by a five-digit number
Patient evaluations of treatment acceptability
Dutch and adapted version of Havnen et al 2013. This questionnaire includes 14
questions about the patients experiences with the Short Intensive 8-day CBT.
The MINI, PDSS or Y-BOCS, IDS, CGI, OQ, and EQ-5D are part of the ROM (Routine
Outcome Monitor) and are on a regular basis assessed in all patients with
anxiety disorders in Overwaal, ProPersona.
'
Adolescents
BDI
Depressive symptoms are assessed with the Beck Depression Inventory (BDI; Beck,
Ward, Mendelson, Mock, Erbaugh, 1961; Dutch version: Schotte, Maes, Cluydts, De
Doncker, & Cosyns, 1997). The BDI is a 21-item, self-report inventory for
measuring the existence and severity of symptoms of depression as listed in the
DSM-IV in adolescents and adults. The internal consistency is high for both
psychiatric and non-psychiatric samples (Cronbach*s alpha ranged from .76 to
.95 and .73 to .92 respectively). The concurrent validity is high in both
psychiatric and nonpsychiatric samples (correlation with clinical ratings: r =
.55 to .96, correlation with Hamilton Rating Scale for Depression: r = .61 to
.86, correlation with Zung: r = .57 to .86, correlation with MMPI-D: r = .41 to
.75; Beck, Steer, & Garbin, 1988). The Dutch version of the BDI also shows good
internal consistency (.91).
MINI KID
The Mini International Neuropsychiatric Interview for children and adolescents
(MINI KID; Sheehan et al., 2010; ) is a structured clinical diagnostic
interview designed to assess the presence of current DSM-IV psychiatric
disorders in children and adolescents aged 6 to 17 years. The MINI-KID is
organized in diagnostic sections or modules. For each disorder the instrument
asks 2 to 4 screening questions; additional symptom questions within each
disorder section are asked only if the screen question are positively endorsed.
The instrument screens for 24 DMV-IV psychiatric disorders and suicidality and
takes approximately a half an hour to administer. Sensitivity was substantial
(0.61-1.00) and specificity was substantial to excellent (0.73-1.00).
Interrater and test-retest kappas were substantial to almost perfect
(0.64-1.00).
KIDSCREEN
The KIDSCREEN (The Kidscreen Group Europe, 2006) questionnaires are a family of
instruments developed and normalized for surveying health-related quality of
life in children and adolescents ages 8 to 18. The questionnaires were
developed simultaneously in 13 European countries with special regard to
childhood concepts of health and well-beeing. The Kidscreen is a self-report
measure that can be administered in hospitals, medical establishments and
schools by professionals in the fields of public health, epidemiology, and
medicine. In this effect-study the Kidscreen-52 will be used for the
adolescent. The parents will be asked to fill in the Kidscreen-27. The
Kidscreen-52 allows detailed profile information for 10 dimensions of
health-related quality of life and requires 15-20 minutes to be filled in. The
Kidscreen-27 allows detailed profile information for 5 dimensions of
health-related quality of life and requires 10-15 minutes to be filled in. The
different versions oft he Kidscreen are all reliable and valide.
Family Accommodation Scale*Parent Report
The Family Accommodation Scale (Calvocoressi et al., 1999) is a 13-item
clinician-rated measure that assesses the degree to which family members have
accomodated the child*s OCD symptoms during the previous month and the level of
distress or impairment that the family members and patient experience as a
result of the family accomodating or not accomodating the child. Areas assessed
include the provision of reassurance or objects for compulsions, decreased
behavioral expectations for the child, modification of family routines, and
help avoiding distressing objects, places, or experiences. Items are rated on a
5-point scale. The FAS demonstrated good psychometric properties. The FAS
demonstrated excellent interrater reliability and good internal consistency and
performed well on assessment of its convergent and discriminant validity.
Patient evaluations of treatment acceptability
Dutch and adapted version of Havnen et al 2013. This questionnaire includes 14
questions about the patients experiences with the Short Intensive 8-day CBT.
In adolescents, the Kidscreen is part of the ROM (Routine Outcome Monitor) and
is on a regular basis assessed in all patients with anxiety disorders in
ProPersona.
Background summary
According to the Dutch Guidelines for the treatment of Anxiety Disorders (DGA;
van Balkom et al, 2013) the first treatment of choice for patients with
obsessive-compulsive disorder (OCD) or panic disorder (PD) is Cognitive
Behaviour Therapy (CBT) and more specific Exposure and Response Prevention
(ERP). The effectiveness of CBT for these disorders has been largely proven
(van Balkom et al, 2013). Also, the effectiveness in children and adolescents
has been largely proven (Skasphedinsson et al., 2015). However, a rather
substantial group of patients (25-35%) does not successfully improve of
outpatient CBT. These are the so called nonresponders or nonremitters. These
nonresponders (and their families/relatives) are at risk for demotivation,
higher health service costs, dropout and longer time to social rehabituation.
The DGA provides pharmacotherapeutic guidelines for nonresponders. The question
is whether further treatment with pharmacotherapy is the best option for this
group of nonresponders. Pharmacotherapy is less cost-effective (Furukawa &
Watanabe, 2006) and patients have the tendency to attribute their improvement
to medication and not to their own actions. Self efficacy will therefore not
improve and tapering of medication will be difficult. Further guidelines for
psychotherapeutic treatment are expert based and not evidence based and imply
mostly intensifying to clinical inpatient treatment or day treatment. These
treatments takes 3-6 months. Scientific evidence for the effectiveness for
these programs is scarce. This is also due to the fact that is hardly
achievable to do scientific research with nonresponders by randomised
controlled trials.
ERP is the most important intervention in the psychotherapeutic interventions
for anxiety disorders. ERP has the intention to expose the patient to his most
feared situation while he does not perform avoidance of safety behaviours to
control his anxiety. This is how the patient will learn that his fearful
expectations will not come true and his anxiety levels will drop. Although ERP
is very successful, a group of patients will not succeed in performing these
exposure exercises by themselves. An explanation can be that they are not
consistent and are too fearful to confront their fears. However, the
performance of exposure exercises are directly correlated to treatment outcome
(Le Beau, Davies, Culver, & Craske, 2013). One of the explanations of
nonresponse is that the nonresponding patient does not succeed in exposure
exercises without avoidance of safety behaviour. Therefor, therapist assisted
exposure could be more effective than non-assisted exposure (Abramowitz, 1996).
Therapy assisted ERP could cause more control over the exercises and the
avoidance and safety behaviours and therefor create more pressure.
Nonresponding patients can expose themselves finally to their fearful
situations and turn into responding patients. The therapist can assist in
different patient-specific situations, in different locations and when
necessary at home. In this manner, also familiy menbers can learn how to cope
with the patients and his compulsive behaviour. This leads immediately to an
positive effect on the treatment (Thomson-Hollands, 2015).
Most intensive (day-) clinical treatments have treatments of months and do not
focus on ERP. A long intensive treatment of months is not desirable because of
the continuity with family life, work and social network, and because of the
high costs. And, possibly, it is not necessary when a short intensive treatment
has a real focus. The focus should be on the intervention with the most
evidence: ERP.
Intensive treatments, with 2-10 treatment days with intensive exposure or
flooding, are effective for OCD (e.g. Abramowitz, Foa, & Franklin, 2003;
Oldfield et al., 2011) and PD (e.g. Britran, Morisette, Spiegel, & Barlow,
2008; Wambach & Rief, 2012).
To the best of our knowledge, there are two studies in which nonresponding
patients with an anxiety disorder who were treated with CBT received an
intensive exposure treatment. Van der Heiden and colleagues (2010) treated 8
patients with PD in an open trial (without control group or randomisation) and
found high effect sizes and a moderate clinical improvement. Dettore, Pozza,
and Coradeschi (2013) also performed an open trial with 48 OCD patients. Effect
sizes were high.
In Overwaal, Centre for Anxiety Disorders, we recently developed an intensive
treatment program for nonresponding patients with PD and OCD, the ICBT. The
present study is aimed to study the feasibility and effeciveness of this
intensive treatment.
Study objective
The present study is aimed to study the feasibility and effects of ICBT for
outpatient nonresponding CBT patients with PD or OCD.
Primary Objective:
1. Is this treatment model effective in terms of reduction in PD or OCD
symptoms?
Secondary Objective(s):
1. What is the effect of the intensive treatment on depressive symptoms?
2. What is the effect of the intensive treatment on quality of life?
3. How is the dropout rate?
4. How do patients experience this intensive exposure treatment?
Study design
The proposed study uses a multiple baseline design. A multiple baseline design
is an experimental design that is well suited to explore the effects of
treatments for disorders with a small chance for spontaneous recovery, such as
PD and OCD. Patients all receive the same intervention but are randomly
allocated to different time periods before and after treatment in which they
are monitored. By assessing the change in symptoms over time, the causal
relation between intervention and outcome can be established. Although a
randomised controlled trial (RCT) is perceived as the gold standard to examine
the effects of a new treatment, the design has shortcomings as well, mainly in
user friendliness and costs. Like an RCT, a multiple baseline design can also
demonstrate that the intervention causes change in symptoms and that a change
is significant (Hawkins, Sanson-Fisher, Shakeshaft, D*Este, & Green, 2007;
Onghena, 2005; Onghena & Edgington, 2005).
Compared to a RCT, a smaller number of participants is needed and the included
participants operate as their own controls.
The present study consists of 4 phases.
T0 Screening
T 1 Baseline 2-8 weeks
T2 Active Intervention ( 6 weeks) : ICBT 2 weeks of 8 days and 4
boostersessions (once per week)
T3 Post treatment 2-8 weeks plus 2 weeks to FU
T4 Follow up after 18 weeks after start baseline (4 weken)
In total, the study takes 22 weeks. During the baseline, post treatment and
follow-up, the weekly assessments can be done by telephone.
10 patients with PD and 10 patients with OCD (age 18-65) and 10 patients with
OCD (age 15-17) will be included in the present study.
randomisation:
7 different baseline randomisations are possible:
1. 2 weeks baseline before treatment - 8 weeks post treatment (1 PS, 1 OCD)
2. 3 weeks baseline before treatment - 7 weeks post treatment (1 PS, 1 OCD)
3. 4 weeks baseline before treatment - 6 weeks post treatment (2 PS, 2 OCD)
4. 5 weeks baseline before treatment - 5 weeks post treatment (2 PS, 2 OCD)
5. 6 weeks baseline before treatment - 4 weeks post treatment (2 PS, 2 OCD)
6. 7 weeks baseline before treatment - 3 weeks post treatment (1 PS, 1 OCD)
7. 8 weeks baseline before treatment - 2 weeks post treatment (1 PS, 1 OCD)
Intervention
Treatment
All patients receive the same intervention of ICBT with ERP. CBT is the
treatment of choice for anxiety disorders (van Balkom et al., 2013). Intensive
CBT (2-10 days) has been proven to be effective is several controlled studies
for OCD (e.g. Abramowitz, Foa, & Franklin, 2003; Oldfield, et al., 2011) and
for PD (e.g. Bitran, Morisette, Spiegel, & Barlow, 2008; Wambach & Relief,
2012). There will be additional family psycho-education sessions, for the
adolescent patients.
In the present study, intensive treatment will be delivered in 8 days (in two
weeks). Patients start in the morning at the treatment site. After a 90 minute
CBT session, in which treatment goals and exercises are discussed, patients go
to different places to do exposure exercises. E.g. PD patients perform
interoceptive exposure exercises, or go with public transportation, or visit
busy marketplaces. OCD patients can go to hospitals, their own home, etcetera
to perform exposure exercises.
Treatment days are: Thursday, Friday, Monday, Tuesday, Thursday, Friday, Monday
and Tuesday. On Wednesdays and in the weekend days patients should perform
exposure exercises on their own and are encouraged to keep practising what they
already achieved .
Patients can bring their partner of a close friend in the morning session to
give psycho-education and help patients with relapse prevention.
After the 8 days ICBT, patients will receive 4 booster sessions of 90 minutes
during 4 weeks and an evaluation session. In the boostersessions, some of the
exposure exercises will be repeated and response prevention will be discussed.
Also, when necessary, orientation on quality of life (work, day-time
activities, goals, and social life) will be discussed (max 4 sessions).
Therapists
Therapist are a fixed team of qualified and experienced CBT therapists or
workers of CBT trainees. They all work at TOP GGZ centre for anxiety disorders
Overwaal and/or at the child/youth department of the centre for mental health
care ProPersona. Overwaal has broad experience and expertise in diagnostic and
treatment of PD and OCD. Supervision will be given by dr. M. Kampman, clinical
psychologist and CBT therapist of Overwaal.
Treatment Integrity
Treatment integrity will be assessed and promoted by the following
interventions:
1) Treatment will be delivered following a treatment manual;
2) Supervisions about treatment
3) Weekly meetings
4) Registrations of sessions, numbers, duration in minutes, content.
Study burden and risks
Patients have to fill in questionnaires, and have a weekly interview (15-30
minutes) during 22 weeks. This is 5-7- hours additional on the questionnaires
patients already have to fill in as a general procedure of Routine Outcome
Monitoring.
The benefits are the decrease of anxiety related symptoms.
.
Tarweweg 2
Nijmegen 6534 AM
NL
Tarweweg 2
Nijmegen 6534 AM
NL
Listed location countries
Age
Inclusion criteria
Patients with a primary diagnosis (DSM IV) of obsessive-compulsive disorder or panic disorder, who had an adequate cognitive behaviour treatment and did not respond ((C)Y-BOCS score of al least 16 or a PDSS score of at least 11).
Exclusion criteria
- Major depressive disorder and/or suicidality
- Psychotic disorder
- Bipolar disorder
- Comorbid diagnosis Hoarding
- Intellectual disability or severe cognitive function disorders
- Inability to fill in questionary
- Inability to focus on treatment because of other problems
- Inability to reduse in alcohol or drugsuse
Additional for adolescents:
- Severe Comorbid Pervasive Developmental Disorder
- Severe disrupted family functioning
- Other problems or problem area's of first priority
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 | NL49574.072.14 |
| OMON | NL-OMON20016 |
| OMON | NL-OMON29480 |