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

Not Applicable

• Conditions: Transdiagnostic symptoms of disturbed sleep; F51; Nonorganic sleep disorders

• Registration Number: DRKS00024419
• Lead Sponsor: ehrstuhl für Klinische Psychologie und Psychotherapie, Ludwig-Maximilians-Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study Completion: 2023-07-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 47

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

(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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)

Secondary Outcome Measures

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