Imagery Rescripting as Treatment for Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2027-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Persistent Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported depression severity and core beliefs, the effectiveness of the treatment is tested.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.

Study Groups

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Baseline-Preparation-Imagery Rescripting-Post Treatment

Each participant follows this sequence: (1) 6-10 weeks waitlist during which no treatment is offered; (2) 5 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 8 to 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The stand-alone ImRs treatment will be based upon the protocol described by Arntz \& Weertman (1999). (This protocol can be modified to tailor the needs of this study more specifically. Possible adaptations shall be based upon the manual developed by Brewin and colleagues (2009) for their study of applying ImRs to depression.); (4) After end of active treatment (ImRs) 5 weeks follow during which only weekly assessments are done.

Group Type EXPERIMENTAL

Imagery Rescripting

Intervention Type BEHAVIORAL

In Imagery Rescripting patients imagine a different sequence of events matching their needs better than what actually happened in traumatic and other adverse (childhood) experiences.

Interventions

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Imagery Rescripting

In Imagery Rescripting patients imagine a different sequence of events matching their needs better than what actually happened in traumatic and other adverse (childhood) experiences.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 therapy sessions (45-60 minutes); weekly measurements (estimate of 5 minutes) and other measurements (estimate of 20 minutes); and the qualitative post-treatment interview (estimate of 60 minutes) during the study period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No