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CompletedNCT02968667Updated Nov 18, 2016

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

A Phase 2 interventional study of Empowerment in Psychotic Disorders, sponsored by Fakeeh College for Medical Sciences. Completed. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Fakeeh College for Medical Sciences · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychotic Disorders
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 102 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Fakeeh College for Medical Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Learning disability
  • Not able to read or write
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention group received 6 weeks of empowerment program

    Behavioral: Empowerment

  • No intervention
    Treatment as usual

    Medications

Interventions

  • BehavioralEmpowerment

    6 weeks of empowerment program and supported face to face discussion

06

What researchers measure

Primary outcomes

  1. Modified Learned Helplessness

    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Time frame: Up to 6 months

Secondary outcomes

  1. Psychiatric symptoms

    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Time frame: Up to 6 months

  2. recovery assessment scale

    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Time frame: Up to 6 months

  3. Empowerment level

    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Time frame: Up to 6 months

  4. Quality of life

    Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)

    Time frame: Up to 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02968667
Lead sponsor
Fakeeh College for Medical Sciences
Responsible party
Abd Alhadi Hasan (Assistant professor, Fakeeh College for Medical Sciences) — Principal investigator
First posted
Nov 18, 2016
Start date
Nov 2015
Primary completion
May 2016
Completion
May 2016
Last update
Nov 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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