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The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial

17. november 2016 opdateret af: Abd Alhadi Hasan, Fakeeh College for Medical Sciences

The Effectiveness of Hopelessness and Helplessness on Recovery Rate Among People Diagnosed With Schizophrenia

A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual [TAU] (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

102

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult aged 16 years or more
  • Able to read and write in an Arabic
  • Able to consent
  • Diagnosed with schizophrenia
  • Volunteers

Exclusion Criteria:

  • Learning disability
  • Not able to read or write

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Intervention group received 6 weeks of empowerment program
6 weeks of empowerment program and supported face to face discussion
Ingen indgriben: Treatment as usual
Medications

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Learned Helplessness
Tidsramme: Up to 6 months
Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
Up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychiatric symptoms
Tidsramme: Up to 6 months
Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
Up to 6 months
recovery assessment scale
Tidsramme: Up to 6 months
Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
Up to 6 months
Empowerment level
Tidsramme: Up to 6 months
Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
Up to 6 months
Quality of life
Tidsramme: Up to 6 months
Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
Up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

14. november 2016

Først indsendt, der opfyldte QC-kriterier

17. november 2016

Først opslået (Skøn)

18. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • FakeehCMS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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