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Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises (GroupPM+)

12. oktober 2020 oppdatert av: Brandon A Kohrt, MD, PhD, George Washington University

Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal

This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).

Studieoversikt

Detaljert beskrivelse

Counselling programmes used in many humanitarian settings are often non- specific with unknown efficacy and safety. Only a few interventions in humanitarian crises have been rigorously tested, and most studied interventions focused on posttraumatic stress disorder. Beyond posttraumatic stress disorder, individuals may have a range of problems including depression, anxiety, and not being able to do daily tasks necessary for survival and recovery. However, interventions are often limited since they tend to target only a single outcome, are usually of longer duration (8-16 sessions) or require professionals.

In low resourced settings interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. World Health Organization aims to develop a range of low-intensity scale-able psychological interventions that address these issues, as part of its mental health Gap Action Program. As a first step a simplified psychological intervention Problem Management Plus (PM+) has been developed. It has 4 core features that make the intervention suitable for low resourced setting exposed to adversities. First, it is brief intervention (5-sessions), delivered individually or in groups; second, it can be delivered by paraprofessionals (high school graduates with no mental health experience), using the principle of task shifting/ task sharing; third, it is designed as a trans- diagnostic intervention, addressing a range of client identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; fourth, it is designed for people in low-income country communities affected by any kind of adversity (e.g. violence, disasters), not just focusing on a single kind of adversity. Recent PM+ trails in Pakistan and Kenya have indicated PM+ to be effective in diminishing depression and anxiety and improving people's functioning and self- selected, culturally relevant outcomes. Group PM+ has been piloted in a district in Nepal, which was affected by the 2015 earthquakes. The pilot was conducted to gather information about the feasibility, safety and delivery of the intervention in the Nepali community settings; and to identify issues around training, supervision and outcomes measures. The pilot trial was successful in terms of acceptability and feasibility and detecting possible problems of compliance, delivery of the intervention, recruitment and retention. The current definitive study will evaluate the effectiveness of Group PM+ in Nepal through a pragmatic cluster randomized controlled trial.

Studietype

Intervensjonell

Registrering (Faktiske)

611

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Morang
      • Biratnagar, Morang, Nepal
        • Transcultural Psychosocial Organization (TPO) Nepal

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. score YES to heart-mind problems on heart-mind screener
  2. score >16 on World Health Organization Disability Assessment Scale

Exclusion Criteria:

  1. Presence of a severe mental disorder (e.g., psychosis)
  2. Alcohol use disorder (score >16 on the alcohol use disorders identification test (AUDIT)

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group problem management plus
Five sessions of group low intensity psychological intervention
Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
Aktiv komparator: Enhanced treatment as usual
Referral to primary health care workers trained in mental health Gap Action Programme.
Referral to primary care workers trained in mental health Gap Action Program Implementation Guide
Andre navn:
  • mental health Gap Action Program-Implementation Guide

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
General psychological distress - General Health Questionnaire
Tidsramme: 20-weeks after baseline
12-item measure of general psychological distress, validated in Nepal
20-weeks after baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Daily functioning - World Health Organization Disability Assessment Scale
Tidsramme: 20-weeks after baseline
12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal
20-weeks after baseline
Depression - Patient Health Questionnaire
Tidsramme: 20-weeks after baseline
9-item measure of depression symptoms, culturally and clinically validated in Nepal
20-weeks after baseline
Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
Tidsramme: 20-weeks after baseline
8-tem measure of post-traumatic stress symptoms validated for use in Nepal
20-weeks after baseline
Cultural idiom of psychological distress - Heart-Mind Screener
Tidsramme: 20-weeks after baseline
2-item locally develop psychological distress screener
20-weeks after baseline
Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support
Tidsramme: 20-weeks after baseline
12-item assessment of perceptions of support from 3 sources: Family, Friends, and a Significant Other
20-weeks after baseline
Somatic symptom burden - Somatic Symptom Scale
Tidsramme: 20-weeks after baseline
8-item brief measure of somatic symptom burden
20-weeks after baseline

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reducing Tension Checklist for Problem Management Plus Skills
Tidsramme: 20-weeks after baseline
10-item measure of behavioral and psychosocial skills related to coping mechanisms
20-weeks after baseline

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studieleder: Mark van Ommeren, PhD, World Health Organization

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.

Generelle publikasjoner

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 (Faktiske)

25. november 2018

Primær fullføring (Faktiske)

30. september 2019

Studiet fullført (Faktiske)

30. september 2019

Datoer for studieregistrering

Først innsendt

31. oktober 2018

Først innsendt som oppfylte QC-kriteriene

17. november 2018

Først lagt ut (Faktiske)

20. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

This will be shared for full trial.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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