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The additive effect of Imaginary Rescripting for treating depressive symptoms in childhood trauma related depression in adolescence: A multiple baseline study among 15 adolescents

The additive effect of Imaginary Rescripting for treating depressive symptoms in childhood trauma related depression in adolescence: A multiple baseline study among 15 adolescents - ImRs as add-on treatment for depressed adolescents with childhood trauma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53322
Enrollment
15
Registered
2023-05-02
Start date
2023-07-21
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

During all three phases participants will receive CAU, weekly sessions (60 minutes) according to the Multidisciplinary Guidelines for Depression - Addendum Youth. During phase B (intervention phase)

Sponsors

GGZ Oost Brabant (Rosmalen)
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Adolescents aged between 16 and 23 years in care at GGZ Oost Brabant • Mastery of Dutch language • Moderate to severe depression after 3 months of Care As Usual (CAU) for depression: o Score > 26 on the IDS-SR (Bernstein et al., 2007) o DSM-5 diagnosis of depression, confirmed with the MDD part of the Mini International Neuropsychiatric Interview - Simplified (MINI-S), Dutch version 1.1. for DSM-5 (Overbeek & Schruers, 2019). • Moderate to severe childhood trauma (CT) before the age of 16 o At least one score above validated cut-offs for the CT subtypes of the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein & Fink, 1998; physical neglect: score >10; emotional neglect: score >15; sexual abuse: score >8; physical abuse: score >10; emotional abuse: score >13) • In the case of suicidal ideation: The patient is in possession of an up to date safety plan • Patient is inclined to give written informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • There is still immediate physical threat/harm/violence in the adolescent*s life which acquires attention i• There is a history of trauma-focused therapy with EMDR, imagery exposure or Imagery Rescripting in regard to the traumatic childhood event • There is alcohol/drug dependence or other sever psychiatric comorbidity (e.g. bipolar disorder, psychotic disorder) that requires clinical attention • There is a primary DSM-5 diagnosis of PTSD or Acute Stress disorder (ASD) • There is acute suicide risk with an indication for hospitalization (further elaborated in the research protocol p.18)

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is defined as depression symptom severity measured with the self-report PHQ-9 three times a week during all phases and measured with the IDS-SR at four time points: before phase A1, between phase A1 and phase B, between phase B and phase A2, and after phase A2.

Secondary

MeasureTime frame
Secondary outcome measures are depression diagnosis and PTSD-diagnosis assessed with a structured interview held at the start and at the end of the study. The level of distressing mental images, suicidal ideation, post-traumatic stress symptoms, resilience are measured at the four time points as described above.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)