TraumaBLAME-LESSNCT05987735
Psycho-education Program BLAME-LESS and It's Effect on Traumarelated Shame and Guilt
A study testing BLAME-LESS in people with Trauma, run by Karakter Kinder- en Jeugdpsychiatrie at 1 site in Netherlands.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Trauma
- What is being tested?
- BLAME-LESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Karakter kinder- en jeugdpsychiatrie
Almelo, Overijssel, 7600 AP
About this study
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.
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 .
Read the 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
- Being tested
- BLAME-LESS
- Keywords
- Shame, Guilt, Defense Response, Defense Cascade, PTSD, Psycho-education, Tonic Immobility, Appeasement
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLAME-LESSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BLAME-LESS Program | Experimental | If allocated to the intervention group, participants will have direct access to the online intervention for two weeks after allocation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 second objective of the research is to examine the effects of the intervention on PTSD symptoms. The Dutch version of the Child and Adolescent Trauma Screener (KJTS-NL; Kooij \& Lindauer, 2019) is a questionnaire for children and adolescents that serves as a screening tool for PTSD symptoms (Sachser et al., 2017). The severity of PTSD symptoms is measured with 20 items, rated on a 4-point Likert scale (range 1-4). A total score below 15 suggests no (clinical) indication of the presence of a PTSD classification, a score between 15 and 20 suggests the possible presence of a clinical PTSD classification, and a score above 20 suggests an increased chance of the presence of a PTSD classification.
Measured: 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 third objective of the research is to examine the effects of the intervention on anxiety and depression symptoms. The Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014) measures Anxiety and Depression symptoms. The lists consist of a dynamic set of item banks based on Computerized Adaptive Testing (CAT). Both questionnaires consist of 8 items. Each question can be answered as follows: never, almost never, sometimes, often, very often.
Measured: 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 fourth objective of the research is to examing the effects of the intervention on posttraumatic cognitions. The Child Posttraumatic Cognitions Inventory (CPTCI; Meiser-Stedman et al., 2009) is a self-report questionnaire that measures trauma-related cognitions in children and adolescents. The questionnaire consists of two subscales (permanent and disturbing change subscale, CPTCI-PC; fragile person in a scary world subscale, CPTCI-SW) with a total of 25 items that can be answered on a four-point Likert scale (ranging from 1 (strongly disagree) to 4 (strongly agree). The English version of the CPTCI has been validated in children aged-6-18 years. The Dutch CPTCI has good reliability and validity (Diehle et al., 2015), high internal consistency (Cronbach's alpha 0.86-0.93), and good convergent validity.
Measured: 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 fifth objective of the research is to examing the effects of the intervention on motivation to engage in traumafocused treatment and to disclose traumatic memories. The Treatment Program and Evaluation Questionnaire (TPEQ; Murphy et al., 2009) assesses readiness and motivation for trauma-focused treatments (Murphy et al., 2009). The questions were answered on a 7-point Likert scale (ranging from 1 = strongly disagree to 7 = strongly agree). A higher score indicates greater willingness and motivation for treatment.
Measured: The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karakter Kinder- en Jeugdpsychiatrie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanda Lambregts-Rommelse, Prof.dr, Principal investigator, Karakter Kinder- en Jeugdpsychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987735
- Sponsor's protocol ID
- Ontschuldig
- Acronym
- BLAME-LESS
- Status last verified
- Jan 2025
- First submitted
- 5 Jul 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05987735
- Acronym / sponsor ID
- BLAME-LESS / Ontschuldig
- Conditions
- Trauma
- Keywords
- Shame, Guilt, Defense Response, Defense Cascade, PTSD, Psycho-education, Tonic Immobility, Appeasement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Karakter Kinder- en JeugdpsychiatrieUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| BLAME-LESS Program | Experimental | Behavioral: BLAME-LESSIf allocated to the intervention group, participants will have direct access to the online intervention for two weeks after allocation. |
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLAME-LESSThe 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. | Behavioural | BLAME-LESS Program |
Primary outcome
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)
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).
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanda Lambregts-Rommelse, Prof.dr principal investigator
Karakter Kinder- en Jeugdpsychiatrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLAME-LESS in people with Trauma, run by Karakter Kinder- en Jeugdpsychiatrie at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.