Imagery Rescripting for Obsessive Compulsive Disorder and Body Dysmorphic Disorder: a Multiple-Baseline Single-Case Experimental Design.
Phase: NA
Conditions: Obsessive-Compulsive Disorder, Body Dysmorphic Disorders, Anxiety Disorders
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Imagery Rescripting for Obsessive Compulsive Disorder 
and Body Dysmorphic Disorder: a Multiple-Baseline Single-
Case Experimental Design.  
 
Version number: 4; Date 23-6-2023 
NCT ID: not yes assigned 
 
 
 

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PROTOCOL TITLE ‘<Imagery Rescripting for Obsessive Compulsive Disorder and Body 
Dysmorphic Disorder: a Multiple-Baseline Single-Case Experimental Design.>’ 
 
Protocol ID 
< > 
Short title 
Treatment of adverse (childhood) experiences in 
OCD and BDD 
Version 
4.0 
Date 
23-6-2023 
Coordinating 
investigator/project leader 
 
Prof. dr. D.A.J.P. Denys 
Head of Department of Psychiatry 
d.denys@amsterdamumc.nl 
Prof. Dr. A.R. Arntz 
Head of Department of Psychology (UvA) 
A.R.Arntz@uva.nl 
Principal investigator(s) (in 
Dutch: hoofdonderzoeker/ 
uitvoerder) 
 
Investigator 
 
Dr. J. Luigjes 
Department of Psychiatry 
j.luigjes@amsterdamumc.nl 
Drs. T.R. van Verseveld 
Department of Psychiatry 
t.r.vanverseveld@amsterdamumc.nl 
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
Amsterdam UMC – location Academic Medical 
Centre (AMC) 
Subsidising party 
n.a. 
Independent expert (s) 
 Dr. R. Mocking 
Department of Psychiatry 
r.mocking@amsterdamumc.nl 
Laboratory sites <if applicable> 
All procedures will be performed at the AMC 
 
 

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PROTOCOL SIGNATURE SHEET 
 
Name 
Signature 
Date 
Head of Department: 
Prof. dr. D.A.J.P. Denys 
Head of Department of Psychiatry, 
AMC 
 
 
 
Principal Investigator: 
Dr. J. Luigjes 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
INTRODUCTION AND RATIONALE .............................................................................11 
2. 
OBJECTIVES ................................................................................................................14 
3. 
STUDY DESIGN ...........................................................................................................15 
4. 
STUDY POPULATION ..................................................................................................17 
4.1 
Population (base) ...................................................................................................17 
4.2 
Inclusion criteria .....................................................................................................17 
4.3 
Exclusion criteria ....................................................................................................18 
4.4 
Sample size calculation ..........................................................................................18 
5. 
TREATMENT OF SUBJECTS .......................................................................................19 
5.1 
Investigational product/treatment ............................................................................19 
5.2 
Use of co-intervention (if applicable) ......................................................................20 
6. 
INVESTIGATIONAL PRODUCT ....................................................................................21 
6.1 
Name and description of investigational  product(s) ...............................................21 
6.2 
Summary of findings from non-clinical studies ........................................................21 
6.3 
Summary of findings from clinical studies ...............................................................21 
6.4 
Summary of known and potential risks and benefits ...............................................24 
6.5 
Description and justification of route of administration and dosage .........................24 
6.6 
Dosages, dosage modifications and method of administration ...............................24 
6.7 
Preparation and labelling of Investigational Medicinal Product ...............................24 
6.8 
Drug accountability .................................................................................................24 
7. 
NON-INVESTIGATIONAL PRODUCT ...........................................................................25 
8. 
METHODS ....................................................................................................................25 
8.1 
Study parameters/endpoints ...................................................................................25 
8.1.1 
Main study parameter/endpoint .......................................................................25 
8.1.2 
Secondary study parameters/endpoints (if applicable) ....................................25 
8.1.3 
Other study parameters (if applicable) .............................................................26 
8.2 
Randomisation, blinding and treatment allocation ..................................................26 
8.3 
Study procedures ...................................................................................................26 
8.4 
Withdrawal of individual subjects ............................................................................29 
8.4.1 
Specific criteria for withdrawal (if applicable) ...................................................29 
8.5 
Replacement of individual subjects after withdrawal ...............................................29 
8.6 
Follow-up of subjects withdrawn from treatment .....................................................29 
8.7 
Premature termination of the study .........................................................................29 
9. 
SAFETY REPORTING ..................................................................................................30 
9.1 
Temporary halt for reasons of subject safety ..........................................................30 
9.2 
AEs, SAEs and SUSARs ........................................................................................30 
9.2.1 
Adverse events (AEs) ......................................................................................30 
9.2.2 
Serious adverse events (SAEs) .......................................................................30 
9.3 
Follow-up of adverse events ...................................................................................31 
9.4 
[Data Safety Monitoring Board (DSMB) / Safety Committee] ..................................31 
10. STATISTICAL ANALYSIS .............................................................................................32 

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10.1 
Primary study parameter(s) ....................................................................................32 
10.2 
Secondary study parameter(s) ...............................................................................33 
10.3 
Other study parameters ..........................................................................................33 
10.4 
Interim analysis (if applicable) ................................................................................33 
11. ETHICAL CONSIDERATIONS ......................................................................................34 
11.1 
Regulation statement .............................................................................................34 
11.2 
Recruitment and consent........................................................................................34 
11.3 
Objection by minors or incapacitated subjects (if applicable) ..................................34 
11.4 
Benefits and risks assessment, group relatedness .................................................34 
11.5 
Compensation for injury .........................................................................................35 
11.6 
Incentives (if applicable) .........................................................................................35 
12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION .............................36 
12.1 
Handling and storage of data and documents ........................................................36 
12.2 
Monitoring and Quality Assurance ..........................................................................36 
12.3 
Amendments ..........................................................................................................36 
12.4 
Annual progress report ...........................................................................................36 
12.5 
Temporary halt and (prematurely) end of study report ............................................37 
12.6 
Public disclosure and publication policy ..................................................................37 
13. REFERENCES ..............................................................................................................38 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS  
 
ABR 
General Assessment and Registration form (ABR form), the application 
form that is required for submission to the accredited Ethics Committee; 
in Dutch: Algemeen Beoordelings- en Registratieformulier (ABR-
formulier) 
AE 
Adverse Event 
AR 
Adverse Reaction 
CA 
Competent Authority 
CCMO 
Central Committee on Research Involving Human Subjects; in Dutch: 
Centrale Commissie Mensgebonden Onderzoek 
CV 
Curriculum Vitae 
DSMB 
Data Safety Monitoring Board 
EU 
European Union 
EudraCT European drug regulatory affairs Clinical Trials  
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation; in Dutch: Algemene Verordening 
Gegevensbescherming (AVG) 
IB 
Investigator’s Brochure 
IC 
Informed Consent 
IMP 
Investigational Medicinal Product  
IMPD 
Investigational Medicinal Product Dossier  
METC  
Medical research ethics committee (MREC); in Dutch: medisch-ethische 
toetsingscommissie (METC) 
(S)AE 
(Serious) Adverse Event  
SPC 
Summary of Product Characteristics; in Dutch: officiële 
productinformatie IB1-tekst 
Sponsor 
The sponsor is the party that commissions the organisation or 
performance of the research, for example a pharmaceutical 
company, academic hospital, scientific organisation or investigator. A 
party that provides funding for a study but does not commission it is not 
regarded as the sponsor, but referred to as a subsidising party. 
SUSAR  
Suspected Unexpected Serious Adverse Reaction 
UAVG 
Dutch Act on Implementation of the General Data Protection Regulation; 
in Dutch: Uitvoeringswet AVG 
WMO 
Medical Research Involving Human Subjects Act; in Dutch: Wet Medisch-
wetenschappelijk Onderzoek met Mensen 

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SUMMARY 
 
Rationale:  
Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD) are in the top 
10 disorders with a reduced quality of life. Fortunately, effective treatments have been 
developed in recent decades with exposure and response prevention (ERP) as the first-line 
treatment. This form of cognitive behavioural therapy has been extensively researched and 
in combination with medication 53% of patients improve and experience remission (Springer 
et al., 2018). However, almost 50% of patients still have symptoms and don’t or only partial 
remit.  
 
This non-or partial response may have a relationship with adverse childhood experiences 
(ACEs), without a mandatory diagnosis of PTSD, that are believed to contribute to the 
development of schemas and personality traits that interfere with therapy. In OCD, 81% of 
patients report intrusive memories. Preliminary evidence suggests a relationship between 
ACEs and OCD and BDD symptoms and suggests an improvement of symptoms after 
treatment of these adverse experiences. This new transdiagnostically perspective on 
symptoms could help in developing new treatment options, especially for patients who do not 
respond sufficiently but maybe also as a stand-alone treatment. A technique like imagery 
rescripting, an old technique from gestalt therapy and used in schema therapy, seems 
promising in treating ACEs. 
 
We hypothesize that a treatment based on targeting the ACE’s (manifested in schema or 
core beliefs) will change underlying mechanisms related to schemas or core beliefs and a 
change in symptom level for OCD and BDD. 
 
Objective:  
Primary Objective:  
Primary objective is the course of schema or core beliefs and change in OCD and BDD. To 
investigate the effectiveness of imagery rescripting on factors presumed to underlie the 
disorder, according to schema theory, and on OCD and BDD symptoms.  
 
Secondary objective: 
The change in OCD and BDD symptoms (full questionnaire), schemata and modes, core 
emotions, mood, affect and obtrusiveness of intrusion.  
 

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Other objectives are research into the working mechanisms of imagery rescripting by 
collecting qualitative data from patients and their practitioner in a qualitative interview. 
 
Study design:  
For this study, a multiple-baseline single-case experimental design (SCED) is used testing 
different outcome variables in 18 OCD patients and 18 BDD patients.  
 
Study population:  
Patients will be recruited at the Amsterdam UMC, location AMC, department of psychiatry in 
the unit 'anxiety disorders' where OCD and BDD are treated. The study is primarily focused 
on patients who have experienced relapse or have not responded adequately to standard 
treatment. However, we also assess individuals for adverse (childhood) experiences, and if 
such experiences are present, they may be eligible for participation in the treatment. After 
intake, patients are referred by the psychiatrist and receive an assessment for this 
intervention in which severity of symptoms, treatment history, and indications for ACE and 
schemata are measured. Eligible participants will have an age of 18 years and beyond, a 
diagnosis of OCD or BDD and a Y-BOCS cut-off score of 20.   
 
Inclusion: 
• 
Meet the criteria for OCD or BDD, a primary diagnosis according to the Diagnostic 
and Statistical Manual of Mental Disorders (5th ed; American Psychiatric Association, 
2013) 
• 
Are aged 18 and beyond  
• 
Dutch literacy 
• 
Cut-off Y-BOCS of 20 
• 
No change in medication. Stable dose at least 6 weeks prior to study.  
 
Exclusion criteria are: 
• 
Current (hypo)mania 
• 
Active suicidal plans 
• 
Current psychosis (excluding delusional symptoms related to disorder) 
• 
Alcohol or drugs abuse as diagnosed by DSM-5 
• 
Electroconvulsive therapy in last 6 months 
• 
Neurological disorder or IQ< 80 
 
Intervention (if applicable):  

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The intervention consists of imagery rescripting, which is an effective treatment for aversive 
or traumatic experiences based on the protocol of Arntz and Weertman (1999). The 
intervention is offered after regular intake with a variable baseline period up to a maximum of 
10 weeks (waiting time). Subjects form their own control condition. Prior to the intervention 
patients receive 1-3 sessions consisting of a 'case conceptualization'. This is followed by the 
intervention in which they receive a 60–90-minute session of ImRs twice a week for the 
duration of six weeks. Follow-up consist of two sessions with evaluation and a qualitative 
interview. There is also a follow-up for measurement of outcome variables after 6-8 weeks. 
 
Main study parameters/endpoints: 
 
Primary outcomes 
- 
Schema or core beliefs, as measured by VAS scales.  
- 
OCD and BDD core symptoms (based on the Y-BOCS, as measured by VAS scales) 
 
Secondary outcomes 
- 
Y-BOCS(-BDD), which is a semi structured interview (5 items about obsession and 5 
items about compulsions). Measure: OCD and BDD symptoms. Frequency: 4 times.  
- 
For BDD: Brown Assessment of Beliefs Scale (BABS), a 7-item semi-structured, 
rater-administered scale. Measure: Insight/delusions. Frequency: pre-post-FU 
- 
Young Schema Questionnaire (YSQ-S3) and Schema Mode Inventory (SMI), a self-
report questionnaire of respectively 90 and 118 items. Measure: Schemata and 
modes. Frequency: pre-post-FU 
- 
Hamilton Rating Scale for Depression (HRSD), a 17-item semi-structured interview. 
Measure: Mood. Frequency: 4 times 
- 
VAS scales measuring core emotions (shame, guilt, anxiety, sadness, anger, disgust, 
repugnance). 
- 
VAS scale measuring affect strength.  
- 
VAS scale measuring obtrusiveness of intrusions. 
- 
Qualitative interview and questionnaire: Imagery rescripting working mechanisms, 
therapeutic alliance, experiential avoidance, changes in cognition 
 
Nature and extent of the burden and risks associated with participation, benefit and 
group relatedness:  
For OCD and BDD this short intervention is aimed at reducing factors presumed to underlie 
the disorder, according to schema theory, and on OCD and BDD symptoms.  

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By targeting ACEs and improving negative schema or core beliefs and OCD and BDD 
symptoms patients will have direct clinical benefits and more experiential and emotional 
processing, supposedly a more durable effect and a shorter treatment compared to treatment 
as usual, which consists of a 16-week treatment one-day per week. For this effect a 
requirement is to increase the emotional processing and therefore it is expected that 
emotions like guilt, shame, sadness and anger first will increase prior to an improvement in 
emotional processing. The practitioner is highly familiar with the heightened emotional 
experiences that may arise, having received comprehensive training on managing emotions 
through the ImRs course, which is mandatory for all practitioners. Additionally, practitioners 
engage in intervision sessions and receive supervision from a clinical psychologist 
specialized in this treatment. In the very unlikely event of a severe emotional response, 
consultation and treatment are available from a psychiatrist within the department.Treatment 
as usual is not withholden, this is an extra intervention which is offered prior to treatment as 
usual.  
 
There will be some burden, which includes a case conceptualization (1-3 sessions) and 
different measurement over the course of the treatment. The subjects are asked to complete 
questionnaires, complete daily short measurements and review the recording of the 
sessions. Furthermore, we ask patient to come to the AMC twice a week for a session of 60-
90 minutes for the duration of the study, which is six/seven weeks. Symptoms and 
experiencing emotions are expected to increase in the first sessions, this is conform 
expectation and necessary for further experiential processing. Further risk is negligible and 
there is no risk associated with the treatment.  
 

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1. INTRODUCTION AND RATIONALE 
 
Anxiety disorders have a lifetime prevalence of 28.8%, with obsessive compulsive disorder 
(OCD) a prevalence of 2-3% and body dysmorphic disorder (BDD) a weighted prevalence of 
1.9% (varies between 0.7 and 12.7%) (Peeters, 2021; Vulink, 2021). Obsessive Compulsive 
Disorder (OCD) and Body Dysmorphic Disorder (BDD) are in the top 10 disorders with a 
reduced quality of life.  
 
Fortunately, effective treatments have been developed in recent decades like cognitive 
behavioural therapy (CBT). This first-line treatment addresses dysfunctional assumptions 
with cognitive restructuring and exposure and response prevention (ERP). This form of 
cognitive behavioural therapy has been extensively researched and, in combination with 
medication, 50-60% of the patients improve. It is proven well in different studies and also in a 
meta-analysis (Eddy et al., 2004).  
 
However, many patients show no or only partial recovery and there is a high relapse rate: 
about 40-50% of patients respond insufficiently to first-line treatment and significantly 
experience symptoms after treatment (Maloney et al., 2019; Peeters, Stappenbelt, et al., 
2021).  
 
Research shows that beneath the symptoms of these disorders may be, among other 
factors, adverse childhood experiences (ACEs) and aversive memories, that according to 
schema theory are believed to contribute to the development of schemas (negative core 
believes about oneself, others and the world) and personality traits that interfere with 
therapy, even without a diagnosis of PTSD (Arntz, 2012; Maloney et al., 2019; Speckens et 
al., 2007; Willson et al., 2016). These negative adverse events are supposedly a predictor of 
an unfavourable course of illness and treatment outcome (Nanni et al., 2012). Data from 
several studies suggest that adverse (childhood) experiences increases the risk of 
developing obsessive compulsive related disorders (OCRDs) such as OCD (Thiel et al., 
2014;) and BDD (Valderrama et al., 2020) and predict a worse outcome (Tibi et al., 2020). 
Speckens study concluded that in OCD, 81% of the patients report intrusive memories 
(Speckens et al., 2007). A meta-analysis of Longobardi et al. identified several negative 
childhood experiences or bullying experiences related to appearance in BDD patients; 
between 28% and 68% of patients with BDD report childhood physical abuse or neglect, 
including appearance-related teasing, and 22-35% report experiences of sexual abuse 
(Longobardi et al., 2022). Overall, these studies indicate a relationship between ACEs and 
symptom development in OCD and BDD and highlight the need for new treatment options.  

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Schema therapy seems promising in addressing adverse childhood experiences and 
especially the experiential techniques (Morina et al., 2017). A technique from Gestalt therapy 
and used in schema therapy addressing adverse childhood experiences, or negative 
experiences related to the symptoms, is imagery rescripting (ImRs). A technique with a focus 
on past experiences but also suitable for future oriented situations and images like intrusions 
(Kadriu et al., 2021). 
 
ImRs intervenes by modifying mental self-representations induced by negative experiences 
in the past and has proven to be effective for emotional symptoms related to aversive 
emotional memories (Morina et al., 2017). In ImRs, aversive memories are activated and 
emotional and cognitive properties of the mental representation of aversive stimuli are 
altered and potentially reconsolidated. It is believed that  ImRs directly devalues or revalues 
the interpretation coupled to stimuli related to the aversive memory and reduces the 
emotional charge and salience of autobiographical memories and associated negative core 
beliefs. For example, a comment from a manager that reminds you of a bullying experience 
in the past in which you were left out can cause the activation of the underlying schema ‘I am 
not likeable and people will reject me’. ImRs can alter the managers’ comment into a less 
emotionally charged memory by changing the emotional meaning of the bullying experience. 
This technique appears not to be useful exclusively for intrusive images or related memories, 
but is more widely applicable for disorders in which aversive experiences are prevalent 
(Arntz, 2012; Hagenaars & Arntz, 2012). 
 
The precise working mechanisms of this technique are not yet fully understood.  
The existing body of research on ImRs has highlighted several explanations for the 
alterations in episodic memory. Brewin’s research suggests that after ImRs a new alternative 
memory is created which competes with the old memory but is retrieved more easily, the so-
called retrieval competition theory (Brewin et al., 2009; Wheatley & Hackmann, 2011). A 
growing body of research suggest ImRs affects the episodic memory by producing a different 
meaning by reattribution and providing in basic needs, providing a different meaning at the 
child level and expression of inhibited responses and a more positive, less toxic 
representation that decreases the emotional charge (Arntz, 2012; Dibbets & Arntz, 2016). 
Others suggest that ImRs provides the integration of a sense of self (Çili et al., 2017) or a 
sense of ‘mastery’, which is a feeling of control about the image/situation (Strohm et al., 
2019). A small amount of literature has been published about obsessive-compulsive related 
disorders (OCRDs) and suggests ImRs is causing a change in the strength of the 
encapsulated negative believes (Lee & Kwon, 2013) or a change in the valence of the 

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associated memory (Dibbets & Arntz, 2016) related to the symptoms and therefore highlights 
it relevance for these disorders (Basile et al., 2018). 
 
Taken together, these studies support the notion that the working mechanisms of ImRs are 
based on a change is the episodic memory. However, from the literature there is not yet 
consensus about what exactly causes this change. Is it a change in the actual content or is it 
mere a change in encapsulated beliefs and associated emotions related to the memory?  
 
Related to OCD and BDD, there is growing body of studies emphasizing the role of ACE’s in 
symptom development and the potential of treatments like schema therapy or ImRs as a 
stand-alone treatment. A few studies have been carried out with ImRs and the application of 
schema therapy elements in CBT in OCD (Basile et al., 2018; Tenore et al., 2020; Thiel et 
al., 2016; Veale et al., 2015).  A limited number of studies have been carried out on BDD 
(Ritter & Stangier, 2016; Willson et al., 2016), in which research has been done on ImRs as a 
stand-alone treatment in patients with intrusions. These studies demonstrated significant 
effects of ImRs on symptom level. However, these studies are based on a limited number of 
sessions (max 1-2 sessions), offered in addition to CBT treatment, with only a focus on past 
aversive events and did not investigate the working mechanisms of ImRs.  
 
In view of all that has been mentioned so far, which is the growing body of literature about 
OCD and BDD mentioning the contribution of ACEs in symptom development, the potential 
of a powerful technique like ImRs in addressing ACEs and thereby influence symptoms, but 
also the limited number of studies and the lack of knowledge about the precise working 
mechanisms of ImRs, one may conclude more research is needed into the efficacy and 
working mechanisms of ImRs as a stand-alone treatment for OCD and BDD. 
 
In this study, therefore, we will investigate the potential of a more elaborate protocol of 12 
sessions of ImRs focusing on past experiences as well as future potential harmful 
experiences (in combination with a more profound case conceptualization). Additionally, this 
study will investigate the working mechanisms of ImRs.  
 
 
 

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2. OBJECTIVES 
 
OBJECTIVES 
 
Primary Objective:  
To investigate the effectiveness of imagery rescripting on factors presumed to underlie the 
disorder (dysfunctional core beliefs), according to schema theory, and on OCD and BDD 
symptoms.  
 
Primary objective is the course of schema or core beliefs and change in OCD and BDD. 
Hypothesis 1: Patients with OCD and BDD who receive a treatment with ImRs will 
show a decrease in strength of dysfunctional schema / core beliefs 
Hypothesis 2: Patients with OCD and BDD who receive a treatment with ImRs 
will show a reduction in primary (OCD or BDD) symptoms. 
 
Secondary objective: 
The course of OCD and BDD symptoms (full questionnaire), schemata and modes, core 
emotions, mood, affect and obtrusiveness of image.  
Hypothesis 1: Patients who receive a treatment with ImRs will improve on OCD and 
BDD symptoms.  
Hypothesis 2: Patient with OCD and BDD who receive a treatment with ImRs will 
show a reduction in schemata and modes scores. For OCD a positive effect is 
hypothesized in the schemata emotional inhibition, failure, unrelenting standards, 
social isolation, mistrust/abuse, defectiveness/shame and in the dysfunctional parent 
modes (especially demanding parent).  
Hypothesis 3: A treatment with ImRs will at first increase emotional symptoms like 
anger and sadness followed by a decrease in these symptoms and especially the 
emotion guilt for OCD and shame for BDD.  
Hypothesis 4: Depressed mood will reduce after treatment with ImRs  
Hypothesis 5: Strength of affect and obtrusiveness of intrusions will decrease over the 
course of the treatment 
 
Other objectives are research into the working mechanisms of imagery rescripting by 
collecting qualitative data from patients and their practitioner in a qualitative interview. 
 
 

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3. STUDY DESIGN 
For this study, a multiple baseline case-series design (MBCD) is used. The justification for 
this design is that it allows to draw inference about the intervention based on a small number 
of participants and without a control group because participants form their own control (which 
is the variable baseline condition). For a visual impression see figure 1 and 2 on page 16) 
 
Our research aims to assess the efficacy of ImRs (up to 12 sessions) as an additional 
intervention prior to standard treatment. It can be utilized as a standalone treatment if there is 
sufficient response or incorporated into the standard treatment protocol if the response is 
insufficient, followed by CBT.After the regular intake patients are seen by researchers for 
indication (T0) for the ImRs study followed by a variable baseline period with a maximum of 
10 weeks (T1) and an assessment (T2) with 'case conceptualization' (charting current 
symptoms, schemata/modes, coping, early experiences with important caregivers, schema 
or core beliefs) and administration of measuring instruments. After case conceptualization 
starts the intervention (T3) with ImRs with approximately nine sessions of ImRs and three 
sessions of 'future imagery rescripting’ (number of sessions is depending on individual case 
conceptualization and therefore can differ). Measurement of outcome variables will take 
place after the intervention phase (T4) and at follow-up (T5). Total duration of the 
intervention is six to seven weeks.  
In case of insufficient response (Y-BOCS>12) participants can enter treatment as usual (CBT 
treatment) at the department of psychiatry, with a duration of 16 weeks or will be referred for 
further treatment elsewhere.  
Measurements at T0 are syndromal screening (SCID-5-S) and measurement of symptoms, 
depression and schema- of core beliefs. At T3 is the measurement of ACEs and further case 
conceptualization. At T0, T2, T4 and T5 OCD and BDD symptoms, mood and beliefs. 
Schemata and modes will be measured at T0 and T5. The measurement of primary 
outcomes (T1-T5) is operationalized by VAS scales which will be administrated daily. Post 
treatment follows a qualitative interview.  
 
Duration of the whole study is approximately 12-18 months, this is based on the availability of 
patients at the unit anxiety disorders, which can vary over time. The setting of the study is the 
unit anxiety disorders at the department psychiatry where mainly OCD and BDD are treated.  
 

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Figure 1 Flowchart research design 
 
 
Figure 2 Flowchart of procedure 
 

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4. STUDY POPULATION 
4.1 Population (base)  
 
Recruitment takes place at the Amsterdam UMC, location AMC, department of psychiatry in 
the unit 'anxiety disorders' where OCD and BDD are treated. After intake, patients receive an 
assessment for ImRs based on treatment history, severity of symptoms and indications for 
ACE and schemata. 
 
It is a within-subject design using parametric and non-parametric testing and visual 
inspection. Randomization tests and visual inspection of the course of daily measurements 
will also be used to measure the changes from baseline to intervention (Bouwmeester & 
Jongerling, 2020). For each participant at least five measurements, but preferably around 20 
measurements per treatment phase, is sufficient.  
 
4.2 Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following 
criteria: 
 
Inclusion: 
• 
Meet the criteria for OCD or BDD, a primary diagnosis according to the Diagnostic 
and Statistical Manual of Mental Disorders (5th ed; American Psychiatric Association, 
2013) 
• 
Are aged 18 and beyond  
• 
Dutch literacy 
• 
Cut-off Y-BOCS of 20 
• 
No change in medication. Stable dose at least 6 weeks prior to study.  
 
Exclusion criteria are: 
• 
Current (hypo)mania 
• 
Active suicidal plans 
• 
Current psychosis (excluding delusional symptoms related to disorder) 
• 
Alcohol or drugs abuse as diagnosed by DSM-5 
• 
Electroconvulsive therapy in last 6 months 
• 
Neurological disorder or IQ< 80 

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4.3 Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation 
in this study: 
 
Exclusion criteria are: 
• 
Current (hypo)mania 
• 
Active suicidal plans 
• 
Current psychosis (excluding delusional symptoms related to disorder) 
• 
Alcohol or drugs abuse as diagnosed by DSM-5 
• 
Electroconvulsive therapy in last 6 months 
• 
Neurological disorder or IQ< 80 
 
4.4 Sample size calculation 
The number of participants was calculated based on a power calculation (via G*Power) using 
paired t-test (two tailed), with a power of 0.8, an alpha of 0.025 (Bonferroni correction) and a 
desired effect size of 0.8.  
 
The effect size was chosen lower than reported Hedge's g from studies by Veale 
(2015):1.16, Wilson et al (2016): 1.16 and Ritter & Stangier (2016): 1,312, the reason is that 
in these studies uncontrolled effect sizes were calculated and therefore the controlled effect 
size (as in this study) is expected to be lower. Comparable studies with a passive control 
condition found hedges g effect sizes of around 0,90. We think therefore an effect size of 0.8 
is reasonable.  
 
The number of participants for this study will be 18 per group (OCD, BDD) with a total of 36 
participants.  
 
 
 

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5. TREATMENT OF SUBJECTS 
 
5.1 Investigational product/treatment 
After informed consent, patients will be allocated into the intervention condition consisting 
of a variable baseline period (control condition) followed by the ImRs-intervention and a 
follow-up period.  The treatment will be delivered by a trained and licenced psychologist 
and they will be part of an intervision and supervision by a clinical psychologist specialized 
in this intervention. 
 
ImRs treatment 
All participants receive twice per week a session with ImRs for the duration of six to seven 
weeks, 60-90 minutes per session. The decision to conduct sessions twice a week is 
based on several factors. Firstly, it helps minimize the likelihood of patients avoiding 
emotional experiences while allowing ample time for recovery between sessions. 
Additionally, there is evidence from the IREM-Freq study indicating that a twice-per-week 
frequency has shown a more favorable effect (Wibbelink et al, 2021). Moreover, a recent 
study conducted by Raabe et al. (2022) specifically focused on the effectiveness of ImRs 
as a standalone treatment with a twice-weekly schedule. Taking these factors into 
account, we have chosen to offer our patients ImRs twice a week. 
Pre-treatment, participants receive 1-3 sessions for the case conceptualization and 
feedback from the questionnaires. This is followed by a baseline period which is variable 
in duration up to a maximum of 10 weeks. After baseline the intervention phase starts. 
After each session participants receive a homework assignment consisting of listening to 
the recording of the session in combination with daily measures of wellbeing and changes 
in measure outcomes.  
 
The process of imagery rescripting typically involves several steps: 
1. Identification of the target memory: The individual, with the help of a therapist, selects 
a specific memory or event that causes distress or triggers negative emotions. 
2. Imagery activation: The person mentally activates the memory and tries to visualize it 
as vividly as possible. They focus on the sensory details, emotions, and thoughts 
associated with the memory. 
3. Exploration of negative beliefs: The individual identifies the negative beliefs or self-
critical thoughts that are connected to the memory. These beliefs might include 
feelings of worthlessness, shame, or guilt. 
4. Imagery rescripting: Once the negative beliefs and emotions are identified, the person 
is guided to imagine a different outcome or a more positive scenario related to the 

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memory. They engage their imagination to create a new version of the event that 
contradicts the negative beliefs and emotions. 
5. Emotional processing: The individual experiences the new version of the memory, 
paying attention to any changes in emotions, beliefs, or physical sensations. By 
repeatedly visualizing the rescripted version, they aim to establish a new and more 
adaptive cognitive and emotional response. 
 
 
5.2 Use of co-intervention (if applicable) 
Psychiatric medication is allowed during the study, if necessary, but alterations in 
medications are asked to prevent. Furthermore, a treatment with rTMS is not desirable but 
not prohibited.  

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6. INVESTIGATIONAL PRODUCT  
Not applicable 
  
6.1 Name and description of investigational product(s) 
This study is not a pharmaceutical study and therefore information about the 
investigational object can be found under 5.1.  
 
 
6.2 Summary of findings from non-clinical studies 
Not applicable to this study.  
 
6.3 Summary of findings from clinical studies 
The findings from clinical studies are summarized here with first the focus on the 
relationship between ACEs and symptoms followed by studies investigating ImRs 
transdiagnostically and specifically OCD and BDD.  
 
In BDD some studies have examined the relationship between ACEs and BDD symptoms. 
A recent a meta-analysis from Longobardi et al. found in 27 studies a moderate effect for 
ACEs and large effect on the relationship between bullying and BDD symptoms, but also 
emotional abuse (Longobardi et al., (2022). They propose their view on BDD as having a 
mental representation of the self as vulnerable, imperfect and inadequate and feelings of 
rejection and shame. Due to the cross-sectional nature of the studies no causal relation 
can be drawn and they note the possibility of fake memories because of heightened risk of 
paranoid thinking. The relationship between ACEs, shame and BDD symptoms is also 
found by a study of Stechler & Henton (2022) who collected data form semi-structured 
interviews of six women with BDD and showed that shame, trauma and dissociation were 
common along with themes as shame about being seen as a person, disgust and 
detachment during intimacy and a flawed self. This was confirmed by Weingarden et al. 
(2018) who found in 83 adults with BDD that shame was significantly higher in BDD 
patients compared to healthy control and psychiatric outpatient groups. In summary there 
is a growing body of literature that recognises a relationship between shame, feelings of 
rejection, the development of early maladaptive schema’s (EMS) and BDD symptoms. 
 
These studies show a relationship between ACEs and symptom development. A growing 
body of literature exists on investigating ImRs as a treatment for several disorders.  
 

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Several studies have investigated schema therapy and especially imagery rescripting in a 
variety of disorders like PTSD, personality disorders, social anxiety disorder and 
generalized anxiety disorder. Imagery rescripting has been proven as a valid technique in 
lowering PTSD symptoms (Arntz et al., 2013; de Haan et al., 2017) and in SAD. A meta-
analysis of Morina et al. (2017) , based on 19 trials showed that ImRs influences the 
different outcomes measures on PTSD, social anxiety disorder, body dysmorphic 
disorder, obsessive compulsive disorder and bulimia nervosa. There is some preliminary 
evidence for the effectiveness of ImRs in MDD (Brewin et al., 2009), in OCD (Veale et al., 
2015) and in BDD (Ritter & Stangier, 2016; Willson et al., 2016). In all studies ImRs was 
applied as a stand-alone treatment. 
 
In 2017 the studies on OCD and BDD were scarce, two studies on BDD and one study on 
OCD. The research was operationalized with a case series design in which a small 
number of participants were frequently measured on primary outcomes like OCD and 
BDD symptoms and secondary outcomes like mood. Number of sessions were one for 
OCD and one and two for the BDD studies. The data from these studies show a large pre-
post effect for BDD (1,161 (Wilson et al, 2016) and 1,312 (Ritter & Strangier, 2016)) and 
for OCD as well (1,032 (Veale et al, 2015). Since 2017 the research on ImRs as an 
adjunct or stand-alone intervention for OCD is extended by two studies. Maloney et al. 
(2019) studied in a SCED design the effect of 1-6 ImRs sessions as an adjunct 
intervention for OCD in 13 patients. The results show that a small number of sessions 
result in a significant reduction in OCD symptoms if past aversive experiences prevailed 
and if symptoms after ERP were still in the mild-moderate range. The study has some 
limitations like a selection bias (own psychologist) and variable randomization and 
therefore the results are preliminary.  
 
A more recent study from Tenore et al. (2020) found in 18 OCD patients that three 
sessions ImRs, focusing on guilt inducing reproaches in early childhood, reduces OCD 
symptoms from screening to 90-day follow up. Limitation is solely focussing on guilt which 
makes it unable to explore other emotion-induced reproaches and not measuring core 
beliefs and emotions. The effect was however clinically significant, and this is in line with 
the study of Basile et al. (2018) in which they found more guilt inducing events with 
parents, more feelings of guilt and need for acceptance and to be seen. Schemata 
associated with these emotions are social isolation, failure, relentless standards, 
vulnerability for disease and negativism. 
 

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The aforementioned studies suggest that ImRs can be used as a treatment for several 
mental disorders with significant effect on symptom level and comorbid disorders like 
depression. The preliminary results show ImRs to influence aversive imagery and 
assumed incapsulated believes, which would make it transdiagnostically promising 
because of the prevalence of adverse experiences in many psychiatric disorders. The 
results also suggests that patients with ACEs have a greater anticipation on events with 
negative outcomes and vivid imagery about prospective events, a so called flashforward 
(Morina et al., 2011). Because of that it is surprising that up to now no research has been 
done on prospective imagery and all the more a combination of retrospective and 
prospective imagery rescripting. Although ImRs being a promising intervention with a 
potence for transdiagnostical applicability, the existing literature on this subject is still 
scarce with a small number of studies, a small number of participants, variability in control 
group and no prospective imagery.  
 
 
Based on the secondary objective of this study, research on emotions is described by 
Strachan et al. (2020) who describe a different mechanism for ImRs other than habituation 
and extinction. The proposed explanation is that learning theories do not explain for the 
change in non-fear emotions like self-disgust, self-blame, and helplessness. They propose 
a clinical study in which self-report measures of schema or core beliefs, assumptions, 
attributions, and appraisals associated with adverse memories can be administered 
before and after ImRs. For OCD, Basile et al (2018), as aforementioned, evaluated forty-
one imagery exercises and found more blame/reproach memories, more expression of 
guilt emotion and needs for acceptance. A recent study by Stechler & Henton (2022) 
found three superordinate themes in semi-structured interviews from six women with 
BDD: the shame in being seen, disgust and detachment during intimacy, and a flawed 
self, unworthy of relationships. This is in line with the findings from Weingarden et al. 
(2018) who followed eight-three adults with BDD treated with an antidepressant and found 
shame to be significantly higher in BDD, to be correlated with severity, greater suicidal 
thought and hopelessness.  
 
In summary there is a growing body of literature that recognises a relationship between 
 
guilt inducing events, the development of early maladaptive schema’s (EMS) and OCD 
symptoms and a relationship between shame and BDD symptoms. The results are   
preliminary and studies still scarce, therefore, more studies are needed that address the 
emotional content of ACEs and effect of treatment of these ACEs on emotions and 
schema or core beliefs and OCD and BDD symptoms.  

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6.4 Summary of known and potential risks and benefits 
Not applicable. The trials discussed have not reported any adverse events. We do not 
anticipate any risk of the intervention except for the potential benefits and risks as 
described under 11.4. 
 
6.5 Description and justification of route of administration and dosage 
 
Not applicable 
 
6.6 Dosages, dosage modifications and method of administration 
 
Not applicable 
 
6.7 Preparation and labelling of Investigational Medicinal Product 
 
Not applicable 
 
6.8 Drug accountability 
Not applicable 
 
 

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7. NON-INVESTIGATIONAL PRODUCT 
Not applicable 
 
8. METHODS 
8.1 Study parameters/endpoints 
8.1.1 Main study parameter/endpoint 
 
Primary outcomes 
- 
Schema or core beliefs, as measured by VAS scales.  
- 
OCD and BDD core symptoms (based on the Y-BOCS, as measured by VAS 
scales) 
8.1.2 Secondary study parameters/endpoints (if applicable) 
 
Secondary outcomes 
- 
Y-BOCS(-BDD), which is a semi structured interview (5 items about obsession 
and 5 items about compulsions). Measure: OCD and BDD symptoms. 
Frequency: 4 times.  
- 
For BDD: Brown Assessment of Beliefs Scale (BABS), a 7-item semi-
structured, rater-administered scale. Measure: Insight/delusions. Frequency: 
pre-post-FU 
- 
Young Schema Questionnaire (YSQ-S3) and Schema Mode Inventory (SMI), 
a self-report questionnaire of respectively 90 and 118 items. Measure: 
Schemata and modes. Frequency: pre-post-FU 
- 
Hamilton Rating Scale for Depression (HRSD), a 17-item semi-structured 
interview. Measure: Mood. Frequency: 4 times 
- 
VAS scales measuring core emotions (shame, guilt, anxiety, sadness, anger, 
disgust, repugnance). 
- 
VAS scale measuring affect strength.  
- 
VAS scale measuring obtrusiveness of intrusions. 
- 
Qualitative interview and questionnaire: Imagery rescripting working 
mechanisms, therapeutic alliance, experiential avoidance, changes in 
cognition. 
 

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8.1.3 Other study parameters (if applicable) 
Additional parameters will be collected, namely: age, marital status, gender, 
ethnicity, level of education, medication use, substance abuse, psychiatric history.  
 
 
8.2 Randomisation, blinding and treatment allocation 
Because all participants receive the same treatment with only a difference in baseline 
duration no randomisation is necessary.  
 
8.3 Study procedures 
Participants will be recruited at the unit anxiety disorders at the department psychiatry 
of the Amsterdam UMC, location AMC. Participants will be referred by the psychiatrist 
at the intake and the contact information will be forwarded to the researcher by the 
coordinator of the OCD and BDD groups. Participants will be asked to give written 
consent to share personal information and the participants will be contacted by the 
main investigator.  
 
Initial screening / case conceptualization  
Initial screening consists of providing patient information via an infographic and/or 
patient folder and guaranteeing privacy, anonymity and confidentiality. Further 
information about the study will be given to the participants and permission to record 
the intervention. If participants want to participate in the study an informed consent is 
asked to be signed. They will be given a week to decide whether they want to 
participate.  
 
Psychiatric assessment 
The screening of potential participants will take place. Prior to baseline screening 
participants will be asked to fill in the screener SCID-5-SV and the schema 
questionnaires (YSQ and SMI). In the indication session the SCID-5-S for syndromal 
disorders, the Y-BOCS(-BDD)/BABS for obsessive compulsive symptoms or body 
dysmorphic symptoms and the HDRS to measure depressive symptoms are 
measured.  
 
Baseline  
Following the psychiatric assessment is the baseline period with a variable duration 
with a maximum of ten weeks in which daily measures will be taken and no 
intervention.   

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Case conceptualization 
After baseline we will conduct a case conceptualization of 1-3 sessions in which we 
integrate the information from the questionnaires and combine this with adverse 
childhood experiences, schema of core beliefs and modes, core emotions, coping 
and triggers for schema activation. This information will be integrated into a document 
(with a conceptualization figure) which will be created together with the participant. 
If not sufficient clear in the case conceptualization, adverse childhood experiences 
can be measured by additional questionnaires like the JTV/CTQ/VBE and for core 
emotions the TRGI and TRSI.  
 
Interventions 
The ImRs intervention starts with 2-weekly sessions of 60-90 minutes for the duration 
of a maximum of six to seven weeks. Participants are asked permission again for 
recording of the session. Furthermore, participants are asked to fill in the Y-BOCS(-
BDD)/BABS pre- and postintervention and daily measures of VAS variables.  
 
End of treatment assessment 
After the intervention participants are asked to fill in the schema questionnaires again 
and a session is planned for the qualitative interview.  
 
Recurring assessments 
As follow-up procedure participants are asked to fill in the schema-questionnaires 
after 6-8 weeks.  
 
Pilot study 
Prior to the study a pilot will be conducted at two patients with BDD/OCD to test the 
abovementioned procedures and assessments. The two pilot patients receive the 
same procedures and assessment as participants in the study. The practitioner will 
adhere to the protocol and document any areas of improvement regarding 
instructions, measurements, and the implementation of the intervention. The primary 
objective is to evaluate the user-friendliness of the protocol. This will be reported back 
to the researchers and taken into consideration for improvements in the protocol.  
 
Overview of assessments 

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The following questionnaires will be administered and this will be assessed using 
Castor: 
 
Table 1. Assessment of measurements  
 
Time 
Screen
-ing 
Indi-
cation 
Baseline 
Pre-
treatment 
Intervention 
Post-
treatment 
FU  
(>3m) 
Demographics 
5 
· 
 
 
 
 
 
 
SCID-5-SV  
20 
· 
 
 
 
 
 
 
SCID-5-S 
60-90 
· 
 
 
 
 
 
 
BSI 
10 
· 
 
· 
 
· 
· 
· 
ACEs 
 
 
 
 
 
 
 
 
YSQ 
35 
 
· 
 
 
 
· 
· 
SMI 
20 
 
· 
 
 
 
· 
· 
Case 
Conceptualization 
120-
180 
 
· 
 
· 
 
 
 
Y-BOCS-(BDD)  
20 
 
· 
· 
 
· 
· 
· 
BABS 
5-10 
 
 
 
 
 
 
 
HDRS 
20-30 
 
· 
· 
 
· 
· 
· 
VAS scales 
(daily) 
 
 
 
· 
 
· 
· 
 
Qualitative 
interview 
60--90 
 
 
 
 
 
· 
 
Optional: 
 
 
 
 
 
 
 
 
JTV/CTQ 
10 
 
· 
 
 
 
 
 
VBE/PCL-
LEC-5 
10 
 
· 
 
 
 
 
 
TRGI/ TRSI 
10 
 
· 
 
 
· 
· 
· 
 
SCID Structured Clinical Diagnostic Interview, BSI Brief Symptom Inventory, ACE Adverse Childhood Experiences, YSQ Young 
Schema Questionnaire, SMI Schema Mode Inventory, Y-BOCS Yale-Brown Obsessive Compulsive Scale (-BDD), BABS Brown 
Assessment of Beliefs Scale, HDRS Hamilton Depression Rating Scale, Visual Analogue Scale, (CTQ Childhood Trauma 
Questionnaire , PCL-5 PTSD checklist for the DSM-5, LEC-5 Life Events Checklist, TRGI Trauma-Related Guilt Inventory, TRSI 
Trauma-Related Shame Inventory 
 
 
 
 

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8.4 Withdrawal of individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any 
consequences. The investigator can decide to withdraw a subject from the study for 
urgent medical reasons. 
8.4.1 Specific criteria for withdrawal (if applicable) 
 
 
Not applicable 
8.5 Replacement of individual subjects after withdrawal 
After withdrawal another participant will be recruited to obtain the number of participants 
(18 for OCD and 18 for BDD). Replacement will only take place in case of withdrawal after 
baseline, not after treatment. Based on the literature the drop-out rate is expected to be 
low.  
 
8.6 Follow-up of subjects withdrawn from treatment 
If a participant decides to terminate the treatment, they have the option to remain in the 
study, allowing their data from the duration of their participation to be included in the 
analysis, with their agreement. In the event of study termination, participants can choose to 
continue their treatment without any consequences. While they would no longer be required 
to participate in additional measurements, they can still opt to receive the ImRs treatment if 
desired. 
8.7 Premature termination of the study 
At any stage the safety board may request reconsideration of the trial. In case of an 
premature ending of the study, the investigator will notify the accredited METC, including 
the reason for termination. In case of termination participants will be notified and the study 
will be ended. In collaboration with the safety board it will be defined what the exact 
consequences are for the study and participants. No criteria are defined for ending.  
 
 

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9. SAFETY REPORTING 
9.1 Temporary halt for reasons of subject safety 
In accordance to section 10, subsection 4, of the WMO, the sponsor will suspend the 
study if there is sufficient ground that continuation of the study will jeopardise subject 
health or safety.  The sponsor will notify the accredited METC without undue delay of a 
temporary halt including the reason for such an action. The study will be suspended 
pending a further positive decision by the accredited METC. The investigator will take 
care that all subjects are kept informed.  
 
9.2 AEs, SAEs and SUSARs 
9.2.1 Adverse events (AEs) 
Adverse events are defined as any undesirable experience occurring to a subject 
during the study, whether or not considered related to [the investigational product / 
trial procedure/ the experimental intervention]. All adverse events reported 
spontaneously by the subject or observed by the investigator or his staff will be 
recorded. 
 
9.2.2 Serious adverse events (SAEs) 
A serious adverse event is any untoward medical occurrence or effect that  
- 
results in death; 
- 
is life threatening (at the time of the event); 
- 
requires hospitalisation or prolongation of existing inpatients’ hospitalisation; 
- 
results in persistent or significant disability or incapacity; 
- 
is a congenital anomaly or birth defect; or 
- 
any other important medical event that did not result in any of the outcomes listed 
above due to medical or surgical intervention but could have been based upon 
appropriate judgement by the investigator. 
An elective hospital admission will not be considered as a serious adverse event. 
 
In case during the study an undiagnosed serious psychiatric illness manifest itself 
the health care provider or general practitioner will be advised, as will also be the 
case if suicidality is manifest but also the consultation of a psychiatrist or crisis 
centre in case of the latter. In case of medical problems the local emergency 
number will be contacted.  

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The sponsor will report the SAEs through the web portal ‘Toetsing Online’ to the 
accredited METC that approved the protocol, within 7 days of first knowledge for 
SAEs that result in death or are life threatening followed by a period of maximum of 8 
days to complete the initial preliminary report. All other SAEs will be reported within a 
period of maximum 15 days after the sponsor has first knowledge of the serious 
adverse events. 
 
9.3 Follow-up of adverse events 
Based on the studies in literature no AES are expected, All AEs will be followed until they 
have abated, or until a stable situation has been reached. Depending on the event, follow 
up may require additional tests or medical procedures as indicated, and/or referral to the 
general physician or a medical specialist. 
SAEs need to be reported till end of study within the Netherlands, as defined in the 
protocol  
 
9.4 [Data Safety Monitoring Board (DSMB) / Safety Committee] 
Not applicable due to the nature of this study (negligible risks of the added intervention on 
top of regular care).  

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10. STATISTICAL ANALYSIS 
General 
It is a within-subject design using parametric and non-parametric testing and visual 
inspection. The number of participants was calculated based on a power calculation (via 
G*Power) using paired t-test (two tailed), with a power of 0.8, an alpha of 0.025 and a 
desired effect size of 0.8 (chosen for lower than reported Hedge's g from studies by Veale et 
al., (2015):1.16, Willson et al., (2016): 1.16 and Ritter & Stangier, (2016): 1,312. The number 
of participants for this study will be 18 per group (OCD, BDD). In total 36 participants.  
 
Randomization tests and visual inspection of the course of daily measurements will also be 
used to measure the changes from baseline to intervention (Bouwmeester & Jongerling, 
2020). For each participant at least five measurements but preferably around 20 
measurements per treatment phase is sufficient.  
 
Missing values 
A limited amount of missing values is no problem for the analysis since it is based on the 
change over time which can still be measured with omissions.  
 
10.1 Primary study parameter(s) 
Parameter 1: difference in VAS scales concerning schema or core beliefs, OCD and 
BDD symptoms as measured by VAS scales 
During the intervention we will measure on a daily basis the change in schema or core 
beliefs and OCD and BDD symptoms based on obsessive thoughts, obsessive 
compulsions and distress. 
 
The baseline serves as a benchmark for assessing change induced by the experimental 
condition. Assessing treatment effects will be done by visual inspection in which the 
pattern of outcomes across the phases is sufficient to identify change if the trend of the 
data in the baseline phase is different from the pattern in the intervention phase. Also 
statistical analysis will be performed such as a time-series analysis if a great variability in 
the data is manifest. With cross-lagged correlations will the coherence (direction and 
relationship of time) between two variables over time be analysed (Joos et al., 1996). 
Cross-lagged correlations can be easily be calculated using software developed by 
Borckardt and colleagues, called Simulation Modelling Analysis (Borckardt et al., 2008). 

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10.2 Secondary study parameter(s)  
Parameter 2: the change in OCD and BDD symptoms (full questionnaire), schemata 
and modes, core emotions, severity of depression, affect and obtrusiveness of 
intrusion. 
During the intervention we will measure on a daily basis the change in core emotions, 
affect and obtrusiveness of image.  
Assessing treatment effects will be the same as under parameter 1,  
 
During the study we will measure at different moments (see figure 1) the change in 
schemata and modes, OCD and BDD symptoms (full questionnaire), mood, affect and 
obtrusiveness of image. 
In order to study the effect of secondary study parameters we will perform statistical 
analysis on scores on the YSQ/SMI, Y-BOCS(-BDD), HDRS, BABS.  
 
10.3 Other study parameters 
Qualitative interview: exploratory analysis on working mechanisms of intervention: 
imagery rescripting working mechanisms, therapeutic alliance, experiential avoidance, 
changes in cognition 
 
10.4 Interim analysis (if applicable) 
Not applicable.  

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11. ETHICAL CONSIDERATIONS 
11.1 Regulation statement 
The study will be conducted according to the principles of the Declaration of Helsinki 
(general Assembly, Fortaleza, Brazil, October 2013) and in accordance with the Medical 
Research Involving Human Subjects Act (WMO) and other guidelines, regulations and 
Acts  
 
11.2 Recruitment and consent 
Participants are recruited from the unit anxiety disorders from the department psychiatry 
of the Amsterdam UMC, location AMC. After the intake process, potential participants will 
be referred by the psychiatrist. The researchers will then reach out to these individuals to 
arrange an on-site screening session. During this session, the patient folder will be 
reviewed, informed consent will be provided and any questions will be addressed. Upon 
agreement, the informed consent form will be signed. Subsequently, an appointment for 
the start of the study will be scheduled for those patients who choose to participate.  
 
11.3 Objection by minors or incapacitated subjects (if applicable) 
Not applicable 
 
11.4 Benefits and risks assessment, group relatedness 
For OCD and BDD this short intervention is aimed at reducing factors presumed to 
underlie the disorder, according to schema theory, and on OCD and BDD symptoms.  
By targeting ACEs and improving negative schema or core beliefs and OCD and BDD 
symptoms patients will have direct clinical benefits and more experiential and emotional 
processing, supposedly a more durable effect and a shorter treatment compared to 
treatment as usual, which consists of a 16-week treatment one-day per week. Treatment 
as usual is not withholden, this is an extra intervention which is offered prior to treatment 
as usual.  
 
There will be some burden, which includes a case conceptualization (1-3 sessions) and 
different measurement over the course of the treatment. The subjects are asked to 
complete questionnaires, complete daily short measurements and review the recording of 
the sessions. Furthermore, we ask patient to come to the AMC twice a week for a session 
of 60-90 minutes for the duration of the study, which is six/seven weeks. Symptoms and 
experiencing emotions are expected to increase in the first sessions, this is conform 

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expectation and necessary for further experiential processing. Further risk is negligible 
and there is no risk associated with the treatment.  
 
11.5 Compensation for injury 
The sponsor/investigator has a liability insurance which is in accordance with article 7 of 
the WMO. 
  
The sponsor (also) has an insurance which is in accordance with the legal requirements 
in the Netherlands (Article 7 WMO).  
 
11.6 Incentives (if applicable) 
Not applicable. In case of extra visits we will investigate the option for video calling, but if 
a visit to the Amsterdam UMC, location AMC, is necessary travel expenses will be 
compensated.  

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12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
12.1 Handling and storage of data and documents 
All study and medical data will be handled confidentially and encrypted in accordance 
with the EU General Data Protection Regulation and the Dutch Act on Implementation of 
the General Data Protection Regulation (in Dutch: Uitvoeringswet Algemene Verordening 
Gegevensbescherming, UAVG). Participant data will be coded with a unique participant 
number and stored in Castor. A subject identification code list linking these participant 
numbers to the participant identification data will be created. This subject identification 
code list will be available to the principal investigators involved in this study only. Only 
staff members (e.g. clinical interns, clerical personnel) authorized by the principal 
investigators, monitoring agency of the AMC will be allowed access to the coded 
participant data. Study data will be recorded coded with a unique study number. A table 
linking these study numbers to the patients’ identification data will be created. This table 
will only be available to the principal investigators and medical doctors / clinical 
psychologists that are involved in this study. Original source documents will be archived 
for a period of 15 years after the report of the study has been finalized. Thereafter, all 
study-related documents will be destroyed. 
 
12.2 Monitoring and Quality Assurance  
Monitoring of the conduct of the study will take place by the CRU, with whom a monitoring 
plan will be made.  
 
12.3 Amendments  
Amendments are changes made to the research after a favourable opinion by the 
accredited METC has been given. All amendments will be notified to the METC that gave 
a favourable opinion.  
 
12.4 Annual progress report 
The sponsor/investigator will submit a summary of the progress of the trial to the 
accredited METC once a year. Information will be provided on the date of inclusion of the 
first subject, numbers of subjects included and numbers of subjects that have completed 
the trial, serious adverse events/ serious adverse reactions, other problems, and 
amendments.  
 

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12.5 Temporary halt and (prematurely) end of study report 
The investigator/sponsor will notify the accredited METC of the end of the study within a 
period of 8 weeks. The end of the study is defined as the last patient’s last visit.  
 
The sponsor will notify the METC immediately of a temporary halt of the study, including 
the reason of such an action.  
    
In case the study is ended prematurely, the sponsor will notify the accredited METC 
within 15 days, including the reasons for the premature termination. 
 
 Within one year after the end of the study, the investigator/sponsor will submit a final 
study report with the results of the study, including any publications/abstracts of the study, 
to the accredited METC. 
 
12.6 Public disclosure and publication policy 
The results of the study will be shared with the participating organizations and 
departments. The results will also be presented at seminars and published in peer-
reviewed journals. No personal information will be shared . researchers will disclose 
research using databases. None of the parties (i.e. sponsor or investigator) have a right of 
veto. 
 
 

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