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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

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Empowerment
Sponsored by
Fakeeh College for Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychotic Disorders

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Treatment as usual

    Arm Description

    Intervention group received 6 weeks of empowerment program

    Medications

    Outcomes

    Primary Outcome Measures

    Modified Learned Helplessness
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 14, 2016
    Last Updated
    November 17, 2016
    Sponsor
    Fakeeh College for Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02968667
    Brief Title
    The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial
    Official Title
    The Effectiveness of Hopelessness and Helplessness on Recovery Rate Among People Diagnosed With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fakeeh College for Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorders

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention group received 6 weeks of empowerment program
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Medications
    Intervention Type
    Behavioral
    Intervention Name(s)
    Empowerment
    Intervention Description
    6 weeks of empowerment program and supported face to face discussion
    Primary Outcome Measure Information:
    Title
    Modified Learned Helplessness
    Description
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
    Time Frame
    Up to 6 months
    Secondary Outcome Measure Information:
    Title
    Psychiatric symptoms
    Description
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
    Time Frame
    Up to 6 months
    Title
    recovery assessment scale
    Description
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
    Time Frame
    Up to 6 months
    Title
    Empowerment level
    Description
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
    Time Frame
    Up to 6 months
    Title
    Quality of life
    Description
    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
    Time Frame
    Up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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