NCT02421237

Brief Summary

The purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

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

March 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

5.4 years

First QC Date

April 10, 2015

Last Update Submit

August 6, 2018

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

  • Change in Internalized Stigma of Mental Illness Scale

    Up to 11 months post baseline

  • Change in Beck Hopelessness Scale

    Up to 11 months post baseline

  • Change in Rosenberg Self-Esteem Scale

    Up to 11 months post baseline

Secondary Outcomes (1)

  • Change in Heinrichs Quality of Life Scale

    Up to 11 months post baseline

Study Arms (2)

Experimental condition

EXPERIMENTAL

Narrative enhancement and cognitive therapy (NECT) groups. Structured psychoeducational and skills-training groups focused on self-stigma and its impact on people with schizophrenia

Behavioral: Narrative Enhancement and Cognitive Therapy

Control condition

ACTIVE COMPARATOR

Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma.

Behavioral: Supportive Group Therapy

Interventions

Narrative Enhancement and Cognitive TherapyBEHAVIORAL
Experimental condition
Supportive Group TherapyBEHAVIORAL
Control condition

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia-spectrum disorder (schizophrenia or schizoaffective)
  • Elevated internalized stigma

You may not qualify if:

  • Current substance dependence
  • Inability to speak English
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Jay College, City University of New York

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 20, 2015

Study Start

March 1, 2013

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)