Back to resultsImagery Rescripting as Treatment for Depression
Primary Purpose
Major Depressive Disorder, Persistent Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Imagery Rescripting
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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.
Sites / Locations
- Academic Center for Trauma and Personality ACTPRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baseline-Preparation-Imagery Rescripting-Post Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Beck Depression Inventory-II
The Beck Depression Inventory-II assesses severity of depression. The minimum score is 0, the maximum score is 63. Higher scores mean worse outcomes.
Brooding intensity
The Brooding subscale of the Ruminative Response Scale assesses intensity of problematic brooding. The minimum score is 5, the maximum is 20. Higher scores mean worse outcomes.
Worry intensity
The Penn State Worry Questionnaire assesses intensity of problematic worrying. The minimum score is 16, the maximum 80. Higher scores mean worse outcomes.
Full Information
NCT ID
NCT05976945
First Posted
July 27, 2023
Last Updated
August 10, 2023
Sponsor
University of Amsterdam
Collaborators
Academic Center for Trauma and Personality
1. Study Identification
Unique Protocol Identification Number
NCT05976945
Brief Title
Imagery Rescripting as Treatment for Depression
Official Title
Imagery Rescripting as a Stand-alone Treatment for Depression: a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Amsterdam
Collaborators
Academic Center for Trauma and Personality
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Persistent Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baseline-Preparation-Imagery Rescripting-Post Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rescripting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression severity
Description
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.
Time Frame
28-32 weeks plus 6 and 12 months follow-ups
Title
Core beliefs strength
Description
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.
Time Frame
28-32 weeks plus 6 and 12 months follow-ups
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
The Beck Depression Inventory-II assesses severity of depression. The minimum score is 0, the maximum score is 63. Higher scores mean worse outcomes.
Time Frame
before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
Title
Brooding intensity
Description
The Brooding subscale of the Ruminative Response Scale assesses intensity of problematic brooding. The minimum score is 5, the maximum is 20. Higher scores mean worse outcomes.
Time Frame
before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
Title
Worry intensity
Description
The Penn State Worry Questionnaire assesses intensity of problematic worrying. The minimum score is 16, the maximum 80. Higher scores mean worse outcomes.
Time Frame
before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
Other Pre-specified Outcome Measures:
Title
patients' experiences
Description
with a semi-structured interview, participants will be interviewed 5 weeks after treatment. A qualitative analysis will be used.
Time Frame
5 weeks after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnoud Arntz, PhD
Phone
+31 20 525 6728
Email
a.r.arntz@uva.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Tauber, MSc
Email
caitlin.tauber@actp.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnoud Arntz, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Center for Trauma and Personality ACTP
City
Amsterdam
ZIP/Postal Code
1062 XD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnoud R. Arntz, PhD
Phone
+31205256810
Email
a.r.arntz@uva.nl
First Name & Middle Initial & Last Name & Degree
Caitlin Tauber, MSc
Email
caitlin.tauber@actp.nl
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.
Learn more about this trial
Imagery Rescripting as Treatment for Depression
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