Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976945
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-07-27
Brief Title:
Imagery Rescripting as Treatment for Depression
Sponsor:
University of Amsterdam
Organization:
University of Amsterdam
Study Overview
Official Title:
Imagery Rescripting as a Stand-alone Treatment for Depression a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-08
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 Imagery Rescripting in depression The main questions it aims to answer are
does Imagery Rescripting lead to a reduction of depression and of believability of negative beliefs held by the participants
does Imagery Rescripting also leads to reductions in worrying and brooding
Participants will wait for 6-10 weeks to assess time effects without treatment followed by 5 weekly preparation sessions 8-12 weekly Imagery Rescripting sessions and 5 weeks post-treatment
Participants will rate the believability of 3-5 core dysfunctional beliefs related to their depression as well as 2 items assessing depression severity on a weekly basis In addition they will fill out more extensive questionnaires on depression worry and brooding before each phase as well as at 5 weeks post-treatment and 6 and 12 months follow-up
does Imagery Rescripting lead to a reduction of depression and of believability of negative beliefs held by the participants
does Imagery Rescripting also leads to reductions in worrying and brooding
Participants will wait for 6-10 weeks to assess time effects without treatment followed by 5 weekly preparation sessions 8-12 weekly Imagery Rescripting sessions and 5 weeks post-treatment
Participants will rate the believability of 3-5 core dysfunctional beliefs related to their depression as well as 2 items assessing depression severity on a weekly basis In addition they will fill out more extensive questionnaires on depression worry and brooding before each phase as well as at 5 weeks post-treatment and 6 and 12 months follow-up
Detailed Description:
In a multiple baseline case series study the effectiveness of Imagery Rescripting ImRs as a treatment for depression will be tested 10 patients with a major depressive disorder MDD or a persistent depressive disorder PDD will be randomized to different waitlist lengths 6-10 weeks after which they will enter a 5-session preparation phase 5 weeks followed by 12 weekly sessions of ImRs After this treatment follow-up assessments take place at 5 weeks 6 and 12 months Primary outcomes are 1 depression severity weekly assessed with the Patient Health Questionnaire PHQ-2 and 2 idiosyncratic core beliefs assessed with visual analogue scales The hypothesis is that primary outcomes reduce more during treatment than during wait or preparation and remain stable or further improve post-treatment Similarly for secondary outcomes depression severity assessed with the Beck Depression Inventory II BDI-II brooding dysfunctional type of rumination assessed with the Ruminative Response Scale RRS Brooding subscale and worrying assessed with the Penn State Worry Questionnaire PSWQ we expect the largest improvement to take place from pre- to post treatment with little change taking place during baseline and preparation and duringafter post-treatment
Results will be analyzed by multilevel analysis pooling the effects of the individual cases Lastly participants will be interviewed 5 weeks post treatment about their experiences with treatment
Results will be analyzed by multilevel analysis pooling the effects of the individual cases Lastly participants will be interviewed 5 weeks post treatment about their experiences with 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