Depression Clinical Trial
Official title:
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
BACKGROUND:
Sleep disturbances are often referred to as a hallmark of PTSD. In a sample of 734
trauma-affected refugees undergoing psychiatric treatment at Competence Centre for
Transcultural Psychiatry (CTP) in the period 2008-2012 99% reported sleep disturbances and
nightmares.
In trauma-affected populations untreated sleep disturbances can uphold and exacerbate both
sleep-related and non-sleep-related PTSD symptoms. Sleep disturbances may also affect the
efficacy of first-line PTSD treatment and constitute a risk factor for poor outcome of
psychiatric treatment. It has been argued that effective treatment of sleep disturbances may
accelerate recovery in PTSD. There is a lack of randomised clinical trials on this relation
in trauma-affected refugees.
The aim of this study is to examine sleep enhancing treatment in refugees with PTSD.
MATERIALS AND METHOD:
The study will include 230 refugees, diagnosed with PTSD, referred to CTP. Patients who give
informed consent will be randomised to four treatment groups.
1. Treatment as usual (TAU); pharmacological treatment according to algorithm and manual
based Cognitive Behavioural Therapy
2. TAU and add-on treatment with mianserin
3. TAU and add-on treatment with Imagery Rehearsal Therapy (IRT)
4. TAU and add-on treatment with mianserin and IRT
RESULTS:
This study is expected to bring forward new knowledge on both medical and therapeutic
treatment of sleep disturbances in trauma-affected refugees.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
| Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
| Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
| Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
| Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
| Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
| Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
| Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
| Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
| Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
| Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
| Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
| Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
| Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
| Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |