NCT01329393

Brief Summary

This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2010

Typical duration for phase_1

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

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 30, 2020

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

February 2, 2011

Last Update Submit

March 27, 2020

Conditions

Keywords

DisabilitySocial SecurityRepresentative Payee

Outcome Measures

Primary Outcomes (1)

  • Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure

    The Heinrich-Carpenter Quality of Life score is derived by summing ratings of individual items after a semi-structured interview. The possible score on any given interview is 0-126. It is a global measure of social functioning with higher scores indicating better functioning.

    Change from Week 0 to Week 24

Study Arms (2)

Benefits Management

EXPERIMENTAL

Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.

Behavioral: Benefits Management

Illness Management and Recovery

ACTIVE COMPARATOR
Behavioral: Illness Management and Recovery

Interventions

Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.

Benefits Management

Recovery Oriented Training in Biopsychosocial Model of Stress and How to Cope with Stress

Illness Management and Recovery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has received treatment for a psychiatric disorder within 60 days of enrollment
  • Receives SSI or SSDI payments totaling at least $600 per month
  • Has an identified outpatient clinician
  • Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months

You may not qualify if:

  • Already has a conservator or representative payee
  • An application to assign a payee or conservator has been initiated
  • Unable to speak and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Living

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Marc I. Rosen, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

April 5, 2011

Study Start

August 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 30, 2020

Record last verified: 2014-07

Locations