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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03699488
Other study ID # 1001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date February 1, 2018

Study information

Verified date February 2019
Source Talkspace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12980
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Diagnosed Depression and/or Anxiety Disorder

Exclusion Criteria:

- Any psychosis related symptoms or disorders

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Talkspace Columbia University, New York University

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Depressive symptoms on the Patient Health Questionnaire - 9 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. Up to 52 weeks
Primary Change from Baseline in Anxiety symptoms on the Generalized Anxiety Disorder - 7 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. Up to 52 weeks
Secondary Mean number of words sent from patient to therapist Word counts of the words contained within messages sent Up to 52 weeks
Secondary Mean number of words sent from therapist to patient Word counts of the words contained within messages sent Up to 52 weeks
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