Imagery Rescripting as Treatment for Depression

Major Depressive Disorder Clinical Trial

Official title: Imagery Rescripting as a Stand-alone Treatment for Depression: a Pilot Study.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 during/after 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Persistent Depressive Disorder

• NCT number: NCT05976945
• Study type: Interventional
• Source: University of Amsterdam
• Contact: Arnoud Arntz, PhD
• Phone: +31 20 525 6728
• Email: a.r.arntz@uva.nl
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Completion date: August 1, 2027