NCT02283385

Brief Summary

There is no current elder abuse service that systematically assesses and provides services to address the mental health needs of older adult abuse victims. The proposed study will investigate the efficacy of a skill-based, mental health intervention to help treat elder abuse victims, bolster mental health outcomes, and improve detection of symptomatology in future screenings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

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

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

October 24, 2014

Last Update Submit

April 30, 2018

Conditions

Keywords

Elder abuseInterventionTreatmentDetection

Outcome Measures

Primary Outcomes (1)

  • Depression (Hamilton Depression Rating Scale)

    To document effectiveness of PROTECT intervention in reducing depressive symptoms. Severity of depression will be assessed at baseline and 12 weeks using the Hamilton Depression Rating Scale as the primary measure.

    12 weeks

Secondary Outcomes (2)

  • Functioning (Behavioral Activation for Depression Scale)

    12 weeks

  • Service Utilization (specialized mistreatment and service outcome questionnaires)

    12 weeks

Study Arms (1)

PROTECT Intervention

EXPERIMENTAL

Participants will receive a brief psychotherapy that builds on Problem Solving Therapy (PST)

Behavioral: PROTECT

Interventions

PROTECTBEHAVIORAL

8-session weekly psychotherapy intervention that combines problem-solving therapy, anxiety management and psycho education developed specifically for this population

PROTECT Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Client of the New York City Department for the Aging's (DFTA) Elderly Crime Victims Resource Center
  • Score of 10 or higher on the Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder 7-item scale (GAD-7)

You may not qualify if:

  • Co-morbid psychiatric disorder other than unipolar non-psychotic major depression that prevents participation in depression and anxiety screening
  • Inability to speak or understand English
  • Cognitive impairment that prevents participation in screening, as determined by screening social worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department for the Aging: Elderly Crime Victims Resource Center

New York, New York, 10007, United States

Location

Jewish Association Serving the Aging

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jo Anne Sirey, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 5, 2014

Study Start

July 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations