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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Behavioral: Empowerment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Learned Helplessness | 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 | 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 | Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May) | Up to 6 months | 
| Empowerment level | 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 | Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May) | Up to 6 months |