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

NCT ID: NCT05987735

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLAME-LESS Program

If allocated to the intervention group, participants will have direct access to the online intervention for two weeks after allocation.

Group Type: EXPERIMENTAL

BLAME-LESS

Intervention Type: BEHAVIORAL

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 three modules.

Waiting-list control group

When a participant is assigned to the waiting-list control group, he or she has a two-week waiting period, after which the participant will have access to the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 three modules.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karakter Kinder- en Jeugdpsychiatrie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nanda Lambregts-Rommelse, Prof.dr

Role: PRINCIPAL_INVESTIGATOR

Karakter Kinder- en Jeugdpsychiatrie

Locations

Karakter kinder- en jeugdpsychiatrie

Almelo, Overijssel, Netherlands

Countries

Netherlands

Other Identifiers

Ontschuldig

Identifier Type: -

Identifier Source: org_study_id