NCT02968667

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 14, 2016

Last Update Submit

November 17, 2016

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Psychiatric symptoms

    Up to 6 months

  • recovery assessment scale

    Up to 6 months

  • Empowerment level

    Up to 6 months

  • Quality of life

    Up to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group received 6 weeks of empowerment program

Behavioral: Empowerment

Treatment as usual

NO INTERVENTION

Medications

Interventions

EmpowermentBEHAVIORAL

6 weeks of empowerment program and supported face to face discussion

Intervention

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged 16 years or more
  • Able to read and write in an Arabic
  • Able to consent
  • Diagnosed with schizophrenia
  • Volunteers

You may not qualify if:

  • Learning disability
  • Not able to read or write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 18, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11