Imagery Rescripting as Treatment for Depression (NCT05976945) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Imagery Rescripting as Treatment for Depression
Netherlands10 participantsStarted 2023-08-10
Plain-language summary
The goal of this multiple baseline case series study is to test Imagery Rescripting in depression. The main question\[s\] 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary diagnosis of MDD as assessed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5)
* Total score of 20\* or above on the BDI-II (cut-off score for moderate depression) (Beck et al., 1996). (\*Based on previous research by Brewin et al. (2009) \& Yuen-tin (2017) demonstrating averages of BDI-II: 34-35, in their population.)
* Age 18-65
* Dutch or English as a first language (or estimated as sufficient to receive treatment in either of these languages without interpreter)
* Willingness to participate in the study (signed informed consent)
Exclusion Criteria:
* DSM-5 Bipolar disorder, type 1 (current or past); if there has been no manic episode the last year patients will be included
* Psychotic disorders (though psychotic features alongside depression will be allowed)
* Organic brain disease
* Intelligence Quotient (IQ) \< 80
* High risk of self-harm or suicide
* Current substance abuse severe level
* Start of new medication within 2 months before beginning the study (medication used for longer periods can be continued; patients are requested to keep medication stable during the course of the study)
* Having received ImRs (either as a stand-alone or embedded in a greater treatment such as cognitive behavior therapy (CBT) or schema therapy) within the last year
* No other evidence-based treatment of MDD is allowed during the study.
* Not able to plan enough time for weekly t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression severity
Timeframe: 28-32 weeks plus 6 and 12 months follow-ups
2
Core beliefs strength
Timeframe: 28-32 weeks plus 6 and 12 months follow-ups