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| Name | Class |
|---|---|
| Academic Center for Trauma and Personality | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| patients' experiences | with a semi-structured interview, participants will be interviewed 5 weeks after treatment. A qualitative analysis will be used. | 5 weeks after end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnoud Arntz, PhD | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Center for Trauma and Personality ACTP | Amsterdam | 1062 XD | Netherlands |
because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 | Jul 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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.
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The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.
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| 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. |
| before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups |
| 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. | before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups |