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OpenTrials
Completed

NCT Number: NCT02968667

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

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.

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Key information

Conditions

Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowerment

Behavioral

6 weeks of empowerment program and supported face to face discussion

Primary outcomes

  1. Modified Learned Helplessness

    Time frame: Up to 6 months

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

Secondary outcomes

  1. Psychiatric symptoms

    Time frame: Up to 6 months

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

  2. recovery assessment scale

    Time frame: Up to 6 months

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

  3. Empowerment level

    Time frame: Up to 6 months

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

  4. Quality of life

    Time frame: Up to 6 months

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

Sponsors and collaborators

Lead sponsor

Fakeeh College for Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2016
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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