DepressionPROTECTNCT02283385
Mental Health Intervention for Elderly Abuse Victims
A study testing PROTECT in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- PROTECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department for the Aging: Elderly Crime Victims Resource Center
New York, New York, 10007
Jewish Association Serving the Aging
New York, New York, 10018
About this study
Official title: Mental Health Intervention for Elderly Abuse Victims: Providing Options to Elderly Clients Together (PROTECT)
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.
- Conditions
- Depression
- Being tested
- PROTECT
- Keywords
- Elder abuse, Intervention, Treatment, Detection
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTECTBehavioural
8-session weekly psychotherapy intervention that combines problem-solving therapy, anxiety management and psycho education developed specifically for this population
| Study group | Role | What they receive |
|---|---|---|
| PROTECT Intervention | Experimental | Participants will receive a brief psychotherapy that builds on Problem Solving Therapy (PST) Receives: Behavioral: PROTECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJul 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- The Fan Fox & Leslie R. Samuels Foundation, Inc., New York City Department for the Aging, Jewish Association Serving the Aging (JASA)
- Responsible party
- Principal investigator, Jo Anne Sirey, Weill Medical College of Cornell University
- Investigators
- Jo Anne Sirey, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283385
- Sponsor's protocol ID
- 1306014011
- Acronym
- PROTECT
- Status last verified
- Apr 2018
- First submitted
- 24 Oct 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Intervention for Elderly Abuse Victims: Providing Options to Elderly Clients Together (PROTECT)
- ClinicalTrials.gov ID
- NCT02283385
- Acronym / sponsor ID
- PROTECT / 1306014011
- Conditions
- Depression
- Keywords
- Elder abuse, Intervention, Treatment, Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- The Fan Fox & Leslie R. Samuels Foundation, Inc., New York City Department for the Aging, Jewish Association Serving the Aging (JASA)
- Study start
- Jul 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROTECT Intervention | Experimental | Behavioral: PROTECTParticipants will receive a brief psychotherapy that builds on Problem Solving Therapy (PST) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROTECT8-session weekly psychotherapy intervention that combines problem-solving therapy, anxiety management and psycho education developed specifically for this population | Behavioural | PROTECT Intervention |
Primary outcome
Depression (Hamilton Depression Rating Scale)
Time frame: 12 weeks
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.
2 secondary outcomes
Functioning (Behavioral Activation for Depression Scale)
Time frame: 12 weeks
Service Utilization (specialized mistreatment and service outcome questionnaires)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Anne Sirey, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTECT in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (Hamilton Depression Rating Scale) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.