NCT00831935

Brief Summary

The purpose of this study is to test a new monitoring technology that uses the sound of a depressed person's speech to assess the severity of depression symptoms. The Vocal Social Signals Platform (VSSP) is software that analyzes the non-verbal characteristics of a person's speech. This study will test this software to see if it could be a useful measurement tool for assessing depression symptoms. Participation in this study requires coming to the research headquarters twice over a three-month period. The first visit is to determine eligibility. Throughout the study, participants will be connected to a telephone system five times, on which they will answer questions about their depression symptoms. After answering questions, their voice will be recorded using a structured speech sample that the participant will read out loud. The participant will also give an unstructured speech sample, which will involve describing a typical day or the last movie s/he saw. The voice samples will be analyzed and compared to the results of the depression symptom questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

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

First Submitted

Initial submission to the registry

May 22, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

2.4 years

First QC Date

May 22, 2008

Last Update Submit

April 5, 2013

Conditions

Keywords

Acoustic properties of voice in depression

Outcome Measures

Primary Outcomes (1)

  • Inventory of Depressive Symptomatology (IDS)

    3 months

Study Arms (2)

Depressed

Depressed individuals, as identified by their referring physician.

Non-depressed

Non-depressed individuals, confirmed to be non-depressed by the Centers for Epidemiological Studies Depression Scale (CES-D).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample - residents in Boston, Massachusetts area and those referred from Boston Medical Center primary care and psychiatry departments.

You may qualify if:

  • Be \> 18 years of age.
  • Speak, understand and read conversational English.
  • A clinical diagnosis of Major Depressive Disorder in the past 2 weeks.

You may not qualify if:

  • Not having access to a telephone at home or on the person (cell phone) or at work.
  • Planning to leave Boston during the study period.
  • Having a long history of smoking, which is defined as 1 pack per day for 10 years or more.
  • Meeting the criteria for alcohol abuse.
  • Having one of the following mental illnesses based on attached instruments: Social Anxiety, Bipolar Disorder (BD) or Borderline Personality Disorder (BPD).
  • Having a life threatening and/or chronic health condition such as organic brain disease, e.g., Alzheimers' Disease and other dementias, cancer, HIV or other autoimmune diseases, diabetes, heart disease, renal failure, etc.
  • Having a physical condition, such as one of the following, that could affect the acoustic characteristics of speech or a condition that can alter vocal production by affecting the mouth, larynx, trachea, lungs, thorax, nose, nasal passages and sinuses, ears and hearing:
  • Neurological events or diseases such as stroke, ALS, brain injury, brain tumors, Parkinson's disease, Huntington's disease and multiple sclerosis
  • Chronic allergic conditions such as allergic rhinitis
  • Upper or lower respiratory track infections such as sinusitis
  • GERD (acid reflux)
  • Anatomic abnormalities such as deviated nasal septum
  • Speech impairment, as determined by the research staff
  • Any other permanent, chronic or intermittent conditions that affect the quality of speech

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ramesh Farzanfar, Ph.D

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations