CClinicalTrials.gg
CompletedNCT02283385PROTECTUpdated May 3, 2018

Mental Health Intervention for Elderly Abuse Victims

An interventional study of PROTECT in Depression, sponsored by Weill Medical College of Cornell University. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2014, registered Oct 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

Despite increasing recognition of the epidemic of elder abuse, we continue to face barriers helping abuse victims access and use elder abuse resolution services. In addition, many victims suffer from concurrent mental health problems that prevent them from taking the necessary steps to protect themselves. The proposed study will introduce a tailored intervention, built on an evidence-based approach (Problem Solving Therapy), to be delivered through a sustainable mental health program embedded in elder abuse services. The proposed psychotherapy is a brief 8-session weekly intervention that combines problem-solving therapy, anxiety management, and psycho education developed specifically for this population by this team.

The objectives of the project are to: identify the mental health needs of elder abuse victims, provide the mental health treatment, assess the impact of the treatment, and facilitate conditions which will sustain the mental health program.

02

Conditions studied

  • Depression

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Keywords

  • Elder abuse
  • Intervention
  • Treatment
  • Detection
03

In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 63 is below the median of 84 across 6,722 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

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

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    PROTECT Intervention

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

    Behavioral: PROTECT

Interventions

  • BehavioralPROTECT

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

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. Functioning (Behavioral Activation for Depression Scale)

    To document effectiveness of PROTECT intervention in increasing quality of life, social interaction, and overall functioning. Severity will be assessed at baseline and 12 weeks using the Behavioral Activation for Depression Scale as the primary measure.

    Time frame: 12 weeks

  2. Service Utilization (specialized mistreatment and service outcome questionnaires)

    To document effectiveness of PROTECT intervention in increasing clients' utilization of elder abuse services and subsequently reporting a reduction in abuse. Service utilization and severity of abuse will be assessed at baseline and 12 weeks using specialized mistreatment and service outcome questionnaires.

    Time frame: 12 weeks

07

Study locations

2 sites
  • Department for the Aging: Elderly Crime Victims Resource Center
    New York, New York 10007, United States
  • Jewish Association Serving the Aging
    New York, New York 10018, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02283385
Lead sponsor
Weill Medical College of Cornell University
Collaborators
The Fan Fox & Leslie R. Samuels Foundation, Inc., New York City Department for the Aging, Jewish Association Serving the Aging (JASA)
Responsible party
Jo Anne Sirey (Associate Professor, Weill Medical College of Cornell University) — Principal investigator
First posted
Nov 5, 2014
Start date
Jul 2014
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
May 3, 2018

Study contacts

Jo Anne Sirey, PhD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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