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Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims

23. april 2014 oppdatert av: Shr-Jie Wang, Rehabilitation and Research Centre for Torture 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

This study will measure the effects of biofeedback supported cognitive behavioral therapy (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims of torture and massive violence with available rehabilitation practice and integrate them into the community. It is also our objective to build local knowledge and expertise to apply measurement principles and CBT methods in the Balkan region.

Studieoversikt

Status

Fullført

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

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Pristina, Kosovo, 10000
        • Kosova Rehabilitation Centre for Torture Victims

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Shr-Jie Wang, Ph.D., Rehabilitation and Research Centre for Torture Victims

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2012

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. april 2014

Datoer for studieregistrering

Først innsendt

25. september 2012

Først innsendt som oppfylte QC-kriteriene

27. september 2012

Først lagt ut (Anslag)

1. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. april 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på BF-CBT and group physiotherapy

3
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