Imagery Rescripting as Treatment for Depression

NCT05976945 | Active Not Recruiting

• 1 other identifier: 2021-CP-14288
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Depression severity

  Depression severity assessed with the first 2 items of the Patient Health Questionnaire-9. The minimum score is 0, the maximum score is 6. A higher score means worse outcome.

  28-32 weeks plus 6 and 12 months follow-ups

• Core beliefs strength

  Idiosyncratic core beliefs related to the depression are formulated together with the participant and weekly rated on Visual Analogue Scales.The mean of the scores is taken, range 0-100. A higher score means a worse outcome.

  28-32 weeks plus 6 and 12 months follow-ups

Secondary Outcomes (3)

• Beck Depression Inventory-II

  before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups

• Brooding intensity

  before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups

• Worry intensity

  before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups

Other Outcomes (1)

• patients' experiences

  5 weeks after end of treatment

Study Arms (1)

Baseline-Preparation-Imagery Rescripting-Post Treatment

EXPERIMENTAL

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.

Behavioral: Imagery Rescripting

Interventions

Imagery Rescripting 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.

Baseline-Preparation-Imagery Rescripting-Post Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Amsterdam: lead
• Academic Center for Trauma and Personality: collaborator

Study Sites (1)

Academic Center for Trauma and Personality ACTP

Amsterdam, 1062 XD, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Arnoud Arntz, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)