- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01696578
Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims
Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in Victims of Torture and Massive Violence in Kosovo: A Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The primary objective of this project is to contribute to the promotion of evidence-based health intervention which is dealing with the long-term consequences of trauma in the post-conflict Kosovo.
This is the second phase of a series of multi-site case studies. Based on the knowledge generated in the first phase of project in 2007-2009, the investigators conclude that there is a need to continue with health interventions in northern Kosovo among those who are still suffering from the long-term effects of trauma. Many problems need to be addressed, ranging from unemployment and sleep disturbances to a high suicide rate. As our study shows, the situation is frequently complicated by co-morbidity between mental and physical problems, in particular, anger, hatred, severe depression and chronic pain.
At this phase, the investigators aim to provide the available rehabilitation service to the victims of torture and massive violence in northern Kosovo. The investigators undertake an integrated intervention approach; that is a biofeedback supported cognitive-behavioral therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on prolong exposure therapy)and a group physiotherapy intervention, which promotes physical fitness and social participation. The ultimate goal of this project is to determine both feasibility and the effectiveness of combined interventions in the countries with limited resources.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Pristina, Kosovo, 10000
- Kosova Rehabilitation Centre for Torture Victims
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Victims of massive violence from northern Kosovo who reported one or more of the following experiences: 1) torture and other cruel, inhuman or degrading treatment or punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt object into a genital organ and/or the rectum; 3) arrest and detention without warrant or order; or 4) extrajudicial execution of family members, perpetrated by members of law enforcement agency.
- Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain
Exclusion Criteria:
- With mental retardation or significant speech or cognitive impairment that would impede assessments
- With past or present schizophrenia
- With major alcoholic or substance abuse problems
- Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months,
- Having had any CBT in the past three years
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BF-CBT and group physiotherapy
Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
|
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
|
Aktiv komparator: Waiting list
The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later
|
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change of depression symptom from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of anxiety symptom from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of chronic pain symptom from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of anger from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of PTSD symptom from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change of disability scale from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of hand-grip strength from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of standing balance from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of BMI from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of heart rate variability from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Change of reporting sleep disorder from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Change of reporting suicide ideation from baseline at 3 and 6 months
Tidsramme: 0-3-6 months
|
0-3-6 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Shr-Jie Wang, Ph.D., Rehabilitation and Research Centre for Torture Victims
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wang SJ, Salihu M, Rushiti F, Bala L, Modvig J. Survivors of the war in the Northern Kosovo: violence exposure, risk factors and public health effects of an ethnic conflict. Confl Health. 2010 May 28;4:11. doi: 10.1186/1752-1505-4-11.
- Wang SJ, Pacolli S, Rushiti F, Rexhaj B, Modvig J. Survivors of war in the Northern Kosovo (II): baseline clinical and functional assessment and lasting effects on the health of a vulnerable population. Confl Health. 2010 Sep 21;4:16. doi: 10.1186/1752-1505-4-16.
- Wang SJ, Rushiti F, Sejdiu X, Pacolli S, Gashi B, Salihu F, Modvig J. Survivors of war in northern Kosovo (III): The role of anger and hatred in pain and PTSD and their interactive effects on career outcome, quality of sleep and suicide ideation. Confl Health. 2012 Jul 30;6(1):4. doi: 10.1186/1752-1505-6-4.
- Wang SJ, Bytyci A, Izeti S, Kallaba M, Rushiti F, Montgomery E, Modvig J. A novel bio-psycho-social approach for rehabilitation of traumatized victims of torture and war in the post-conflict context: a pilot randomized controlled trial in Kosovo. Confl Health. 2017 Feb 8;10:34. doi: 10.1186/s13031-016-0100-y. eCollection 2016.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RCTF5S2P4D1
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