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Acceptance and efficacy of a transdiagnostic group-intervention for sleep disorders in male Afghan refugees: a pilot RCT

Acceptance and efficacy of a transdiagnostic group-intervention for sleep disorders in male Afghan refugees: a pilot RCT - STARS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024419
Enrollment
48
Registered
2021-03-22
Start date
2021-05-21
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Transdiagnostic symptoms of disturbed sleep F51

Interventions

Group 1: Intervention group: 10 weekly sessions of manualized group intervention (90 min each) for sleep disturbances ("Sleep Training Adapted for Refugees - STARS") based on e. g. Cognitive-Behaviora

Sponsors

Lehrstuhl für Klinische Psychologie und Psychotherapie, Ludwig-Maximilians-Universität München
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
16 Years to 35 Years

Inclusion criteria

Inclusion criteria: (1) being a refugee or asylum-seeker (2) self-reported sleep disturbances (3) dari-speaking or sufficient German skills to be able to communicate with the therapists (4) being able to stay at study location for at least six months (5) willingness for stable medication 4 weeks prior to T1 and during intervention until last assessment

Exclusion criteria

Exclusion criteria: (1) presenting with severe psychiatric symptoms that cannot be handled in a group intervention setting (based on clinical expertise by the study coordinators in the screening session), e.g. acute suicide risk, severe dissociation, acute psychotic or manic symptoms, substance dependance, aggressive behavior (2) pre-diagnosed schizophrenia, bipolar disorder or substance dependance (3) severe physical illness (4) pre-diagnosed severe cognitive impairment (5) psychotherapy elsewhere

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index (ISI)

Secondary

MeasureTime frame
Sleep-related parameters: - Nightmare Disorder Index (NDI) - Coping-scale of the Cognitive Appraisal of Nightmares Scale (CAN) - Fear of Sleep Inventory - Short Form (FOSI-SF) Mental-health-related parameters: - Hopkins-Symptom-Checklist-25 (HSCL-25) - PTSD Checklist for DSM-5 (PCL-5) - WHO Quality of Life Questionnaire - 8 item version (EUROHIS-QOL-8) Intervention-related parameters: - Client Satisfaction Questionnaire (CSQ-4) - AE, SAE, discomfort in combination with psychotherapy (checklist) - Compliance: Attendance to sessions - Compliance: Reason for Dropout - Self-reported therapeutic adherence - change in medication

Countries

Germany

Contacts

Public ContactBritta Dumser

Ludwig-Maximilians-Universität München, Lehrstuhl Klinische Psychologie und Psychotherapie

britta.dumser@psy.lmu.de00498998295712

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026