An interventional study of Imagery rescripting in Obsessive-Compulsive Disorder, Body Dysmorphic Disorders and Anxiety Disorders, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
The goal of this multiple baseline case series study is to test the effect of imagery rescripting (ImRs) in Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD).
Primary objective :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.
Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview.
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. After a variable baseline period of 3-8 weeks participants will start twice weekly with imagery rescripting for 12 sessions, followed by a 6 week follow up.
Participants will rate schema- or core beliefs and OCD or BDD severity on a visual analogue scale. In addition participants will rate core emotions, affect and obtrusiveness of the intrusion. Secondary we will asses four times questionnaires about OCD of BDD symptoms, depression and schemas en modes. After treatment participants will be interviewed about their experiences.
In a multiple baseline case series study the effectiveness of Imagery Rescripting (ImRs) as a treatment for Body Dysmorphic Disorder (BDD) and Obsessive Compulsive Disorder (OCD) will be researched. 18 participants with OCD and 18 participants with BDD will be randomized to a waiting list with variable length between 3-8 weeks. After this participants will enter a 1-3 session for preparation followed by 12 sessions with ImRs, given twice-weekly. Follow up assessment will take place 6 weeks after ending treatment. Primary outcome is schema of core beliefs and OCD or BDD symptoms, operationalized by daily measures with visual analogue scales. Also 4 times the investigator measures the OCD or BDD symptoms with the Yale Brown Obsessive Compulsive Scale (Y-BOCS), depression with the Hamilton Depression Rating Scale (HDRS) and 3 times the schema and mode questionnaires with the Young Schema Questionnaire (YSQ) and de Schema Mode Inventory (SMI). The hypothesis is that the primary outcomes will reduce more during the intervention phase compared to the baseline phase and remain stable or even further improve in the follow-up phase. For the secondary outcomes the investigator hypothesized a decrease in depressive symptoms, a decrease in the emotions guilt or shame and first an increase in sadness, fear and angriness followed by an decrease. The largest effect is expected from pre- to post treatment, with a relative stable little change during baseline and follow-up.
Results will be analyzed using visual inspection, repeated measures ANOVA and multilevel analysis, pooling the effects of the individual cases. Finally, participants will be interviewed post treatment about their experiences during treatment.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 36 is below the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baseline consists of a random assigned period of 3-8 weeks with measurements and no intervention. Intervention consists of a maximum of 12 sessions of imagery rescripting, provided twice-weekly. Post treatment follow up consists of 6 weeks with only measurements and no intervention.
Behavioral: Imagery rescripting
In Imagery Rescripting participants imagine a different sequence of events based on missed emotional needs and rescript until needs are fulfilled. Duration of sessions is up to 90 minutes.
Schema of core beliefs
Idiosyncratic schema- or core beliefs related to Obsessive Compulsive Disorder (OCD) or Body Dysmorphic Disorder (BDD) are daily rated on a Visual Analogue Scales (VAS). The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.
Time frame: 15-22 weeks
Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms
OCD and BDD severity is assessed with items based on the Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD)) rated on a Visual Analogue Scale. The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.
Time frame: 15-22 weeks
Core Emotions, affect strength, obtrusiveness of intrusion.
Rated on a Visual Analogue Scale. The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.
Time frame: 4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)
Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD))
Y-BOCS(-BDD) assesses severity of OCD or BDD symptoms. The minimum score is 0, the maximum score is 48. A higher score indicates symptom severity.
Time frame: 4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)
Hamilton Depression Rating Scale (HDRS)
The Hamilton Depression Rating Scale assesses severity of depression. The minimum score is 0, the maximum score is 52. A higher score indicates symptom severity.
Time frame: 4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)
Young Schema Questionnaire (YSQ) and Schema Mode Inventory (SMI)
The Young Schema Questionnaire and the Schema Mode Inventory assesses severity of schemas and modi. The minimum score per scale is 0, the maximum score is 6. A higher score indicates symptom severity..
Time frame: At start, after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)
Qualitative interview
With an interview, participants will be interviewed after treatment. A qualitative analysis will be used.
Time frame: Post treatment up to 8 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Due to privacy regulations patient data will not be shared unless the European Union (EU) regulations on data protection are guaranteed.
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