Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346301
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-12
Brief Title:
Imagery Rescripting as a Stand-alone Treatment for OCD and BDD
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Imagery Rescripting for Obsessive Compulsive Disorder and Body Dysmorphic Disorder a Multiple-Baseline Single-Case Experimental Design
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None