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Enrolling by invitation NCT05987735

Psycho-education Program BLAME-LESS and It's Effect on Traumarelated Shame and Guilt

No phase Interventional Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BLAME-LESS.
Who it may be relevant to
Registry conditions: Trauma. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BLAME-LESS STUDY: a Two-arm Randomized Controlled Trial Evaluating the Effects of an Online Psycho-education Program for Adolescents Who Experienced (sexual) Violence.

Overview

The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program in reducing trauma-related feelings of shame and guilt in adolescents who experienced sexual or physical abuse .

Detailed description

The study follows a two-arm RCT (n=34). The effects of a brief online psychoeducation program will be compared, with a waiting-list control group. The intervention aims to reduce feelings of trauma-related shame and guilt that adolescents experience regarding their own defense responses during and after (sexual) violence. Assessments take place after screening, at baseline, two weeks after allocation to the intervention or waiting-list, and, only for the waiting-list participants, seven weeks after allocation to the intervention.

Interventions

  • Behavioral BLAME-LESS
    The BLAME-LESS program was designed to educate about common defense responses that may occur during and after (sexual) violence. The main goal of the program is to reduce the feelings of shame and/or guilt related to these responses. The program was created in collaboration with licensed developmental and clinical psychologists with extensive psycho-trauma expertise, young adults who are experienced experts, visual artists, and web designers. The program is offered via a website and consists of

Primary outcome measures

  • Primary outcome: Changes in Feelings of Shame and Guilt [Time frame: The SGATS will be assessed at before treatment (T1 = Week 1), after treatment (T2 = Week 4, T3 = week 7)]
Secondary outcome measures (4)
  • Secondary outcome: Changes in Posttraumatic Stress Symptoms [Time frame: The KJTS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7).]
  • Secondary outcome: Changes in Depression and Anxiety Symptoms [Time frame: The PROMIS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]
  • Secondary outcome: Changes in Posttraumatic Cognition [Time frame: The CPTCI will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]
  • Secondary outcome: Changes in motivation and disclosure [Time frame: The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]

Eligibility criteria

Inclusion criteria

  • the participant experienced one or more traumatic life events, including (sexual) violence as indicated by the CTSQ;
  • the participant reported one or more feelings of guilt and/or shame on the CERQ (items 1 and/or 10 and/or 19 and/or 28)
  • the participant being fluent in written and spoken Dutch;
  • the participant is motivated and available for a period of seven weeks to engage in the study, including the psychoeducation program BLAME-LESS, and commit to the assessments.

Exclusion criteria

  • acute suicidal behavior or suicidal ideations requiring immediate hospitalization;
  • the participant has already read the book that this program is based upon: "Paralyzed with Fear" (In Dutch: Verlamd van Angst, van Minnen 2017), or has been intensively informed otherwise in the past 12 months by a psychologist about common defense responses during and after trauma;
  • Cognitive Impairments (IQ < 70);
  • the participant has a brother or sister in the present study;
  • the participant is already involved in trauma-focused treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Karakter kinder- en jeugdpsychiatrie — Almelo

Identifiers

NCT: NCT05987735 · Ontschuldig

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗