Clinical trial NCT05987735: Psycho-education Program BLAME-LESS and It's Effect on Traumarelated Shame and Guilt
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Trauma
Keywords: Shame
Guilt
Defense Response
Defense Cascade
PTSD
Psycho-education
Tonic Immobility
Appeasement
Lead sponsor: Karakter Kinder- en Jeugdpsychiatrie
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary outcome: Changes in Feelings of Shame and Guilt
timeFrame: The SGATS will be assessed at before treatment (T1 = Week 1), after treatment (T2 = Week 4, T3 = week 7)
Secondary outcomes:
measure: Secondary outcome: Changes in Posttraumatic Stress Symptoms
timeFrame: The KJTS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7).
measure: Secondary outcome: Changes in Depression and Anxiety Symptoms
timeFrame: The PROMIS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)
measure: Secondary outcome: Changes in Posttraumatic Cognition
timeFrame: The CPTCI will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)
measure: Secondary outcome: Changes in motivation and disclosure
timeFrame: The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Karakter kinder- en jeugdpsychiatrie
state: Overijssel
Study officials:
affiliation: Karakter Kinder- en Jeugdpsychiatrie
name: Nanda Lambregts-Rommelse, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References: