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Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699488
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Columbia University
New York University
Information provided by (Responsible Party):
Talkspace

Brief Summary:
Therapies delivered via technology have been developed to improve accessibility, however, there is limited research regarding messaging therapy in particular, and none that we know of utilizing a longitudinal effectiveness design. The aim of this study was to investigate the overall effectiveness of messaging therapy, identify any contributors to its effectiveness, and to evaluate a dosage effect for this type of treatment.

Condition or disease Intervention/treatment
Depressive Symptoms Anxiety Disorders Behavioral: psychotherapy via asynchronous message

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Study Type : Observational
Actual Enrollment : 12980 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Asynchronous Messaging Therapy for Depression and Anxiety: A Longitudinal Study
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Behavioral: psychotherapy via asynchronous message
    Behavioral psychotherapy delivered by asynchronous message using the Talkspace application


Primary Outcome Measures :
  1. Change from Baseline in Depressive symptoms on the Patient Health Questionnaire - 9 [ Time Frame: Up to 52 weeks ]
    Patient Health Questionnaire - 9 (PHQ-9) is a measure of depression symptoms. It has 9 items, with a minimum of 0 and a maximum of 27, with higher scores indicating more symptoms and distress. Decreasing scores indicate better outcome. All items are summed to give the summary score.

  2. Change from Baseline in Anxiety symptoms on the Generalized Anxiety Disorder - 7 [ Time Frame: Up to 52 weeks ]
    Generalized Anxiety Disorder - 7 (GAD-7) is a measure of anxiety symptoms. It has 7 items, with a minimum of 0 and a maximum of 21, with higher scores indicating more symptoms and distress. Decreasing scores indicate better outcome. All items are summed to give the summary score.


Secondary Outcome Measures :
  1. Mean number of words sent from patient to therapist [ Time Frame: Up to 52 weeks ]
    Word counts of the words contained within messages sent

  2. Mean number of words sent from therapist to patient [ Time Frame: Up to 52 weeks ]
    Word counts of the words contained within messages sent



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals seeking psychotherapy services through digitally-mediated application who present with and are diagnosed with a depression and/or anxiety related disorder.
Criteria

Inclusion Criteria:

  • Diagnosed Depression and/or Anxiety Disorder

Exclusion Criteria:

  • Any psychosis related symptoms or disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699488


Sponsors and Collaborators
Talkspace
Columbia University
New York University
Investigators
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Principal Investigator: Matteo Malgaroli, PhD New York University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Talkspace
ClinicalTrials.gov Identifier: NCT03699488    
Other Study ID Numbers: 1001
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for both studies is available in addition to the study protocol and statistical analysis plan. IPD includes demographic information for patient and therapist, as well as outcome scale summary scores for each time point.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data is available from October 10, 2018 to October 10, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Talkspace:
technology
messaging psychotherapy
depression
anxiety
telehealth
Additional relevant MeSH terms:
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Depression
Anxiety Disorders
Behavioral Symptoms
Mental Disorders