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

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968667
• Other study ID #: FakeehCMS
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2016
• Last updated: November 17, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Fakeeh College for Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Empowerment
6 weeks of empowerment program and supported face to face discussion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fakeeh College for Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Psychiatric symptoms	Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)	Up to 6 months	No
Secondary	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	No
Secondary	Empowerment level	Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)	Up to 6 months	No
Secondary	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	No