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

NCT05987735 | Enrolling By Invitation

• 1 other identifier: Ontschuldig
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 .

Conditions

Trauma

Keywords

Shame; Guilt; Defense Response; Defense Cascade; PTSD; Psycho-education; Tonic Immobility; Appeasement

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Changes in Feelings of Shame and Guilt

  The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program, BLAME-LESS, compared to a waiting-list control group of adolescents (12 - 18 years) who experienced sexual or physical abuse in reducing trauma-related feelings of shame and guilt. The Shame and Guilt After Trauma Scale (SGATS) (Aakvaag et al., 2016) measures trauma-related shame and guilt. The SGATS consists of nine items, four on trauma-related feelings of shame and five on trauma-related feelings of guilt (Aakvaag et al., 2016). Each question can be answered on a 3-point Likert scale (0 = no, 1 = yes, a little, 2 = yes, a lot).

  The SGATS will be assessed at before treatment (T1 = Week 1), after treatment (T2 = Week 4, T3 = week 7)

Secondary Outcomes (4)

• Secondary outcome: Changes in Posttraumatic Stress Symptoms

  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

  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

  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

  The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)

Study Arms (2)

BLAME-LESS Program

EXPERIMENTAL

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

Behavioral: BLAME-LESS

Waiting-list control group

NO INTERVENTION

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.

Interventions

BLAME-LESS 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.

BLAME-LESS Program

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karakter Kinder- en Jeugdpsychiatrie: lead

Study Sites (1)

Karakter kinder- en jeugdpsychiatrie

Almelo, Overijssel, 7600 AP, Netherlands

Location

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nanda Lambregts-Rommelse, Prof.dr

  Karakter Kinder- en Jeugdpsychiatrie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a two-arm randomized controlled trial (RCT). . Participants will be randomized into either the intervention group or waiting-list control group. If allocated to the intervention group, participants will have direct access to the online intervention for two weeks after allocation. 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. Assessments take place after screening (T0), at baseline (T1), and two weeks after allocation (T2). Participants in the waiting-list group will also be assessed two weeks after they have gained access to the intervention (T3).

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)