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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

NCT ID: NCT02968667

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

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.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Intervention group received 6 weeks of empowerment program

Group Type EXPERIMENTAL

Empowerment

Intervention Type BEHAVIORAL

6 weeks of empowerment program and supported face to face discussion

Treatment as usual

Medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Empowerment

6 weeks of empowerment program and supported face to face discussion

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fakeeh College for Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Abd Alhadi Hasan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FakeehCMS

Identifier Type: -

Identifier Source: org_study_id