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

November 17, 2016 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group received 6 weeks of empowerment program
Behavioral: Empowerment
6 weeks of empowerment program and supported face to face discussion
No Intervention: Treatment as usual
Medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 6 months
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)
Up to 6 months
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)
Up to 6 months
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)
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakeeh College for Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FakeehCMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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