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REFRESH

REfreshment of dialectical behaviour therapy for veterans to Further reduce symptoms and prevent Relapse of post-traumatic stress disorder and Emotion regulation symptoms by guided Self-Help - REFRESH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61234
Enrollment
24
Registered
2025-07-21
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder Trauma

Interventions

All patients in the study receive hybrid DBT, which consists of individual DBT sessions, group DBT sessions and eHealth platform participation by making homework assignments.

Sponsors

Sinai Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a participant must meet all of the following criteria:Adult veteran (18 years or older), treated at Sinai Center, with knowledge of DBT; Who has a primary diagnosis of PTSD, determined with CAPS-5, resulting from war-related traumas; Who has been stable for four weeks on their medication (type and dose); Who is able to do online homework assignments and communicate with their therapist via an eHealth platform; Who speaks Dutch.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Chronic psychosis (psychotic features as comorbidity from PTSD is allowed) or bipolar disorder type 1 (information collected from directing practitioner about psychosis and personality disorders and, when in doubt, clinical impression will determine if study participation is suitable);IQ below 80 or cognitive disorders (information collected from directing practitioner about cognitive functioning and, when in doubt or upon indication, a standardized reading test (in Dutch: screener voor intelligentie en licht verstandelijke beperking, SCIL) will be administered). Severe self-harming behaviour, such as auto-mutilation or suicidal ideations, is the main problem (as determined by directing practitioner). If client scores = 21 on the SIDAS (suicidality questionnaire), the directing practitioner will discuss with the client if participation is suitable in their treatment plan. For clients for whom the hybrid DBT is not suitable, the standard extended DBT programme is indicated; Following day treatments or other intensive treatments for their residual symptoms because these interventions are too invasive to do next to the hybrid DBT program and may influence the results of the study. 

Design outcomes

Primary

MeasureTime frame
The primary aim of this study is to determine the effectiveness of hybrid DBT for veterans after following a 3-month inpatient DBT program in further reducing their PCL-5 (PTSD) and DERS (emotion regulation) scores. 

Secondary

MeasureTime frame
In addition, the effectiveness of the intervention will be monitored by a weekly questionnaire (REFRESH; specifically tailored to this population) to show a trend line of the treatment. Tertiary parameters are a) emotion regulation (NSSI-AT, SIDAS, LPFS, and AVL), b) general psychiatric symptoms (OQ-30.2), c) substance use (AUDIT  and DUDIT) and d) experience of self- efficacy (i-ROC and DSES). Lastly, we will explore if the hybrid DBT program is effective in preventing relapse in emotion regulation problems (e.g., anger and coping) and PTSD symptoms. Social network (ISB) and socioeconomic factors, such as daily activity pattern, housing and financial problems (questions taken from TiC-P) are used as moderators. 

Countries

Netherlands

Contacts

Public ContactK Thomaes

Amsterdam UMC

k.thomaes@sinaicentrum.nl06 5264 8538

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026