Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study
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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
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Condition or disease | Intervention/treatment |
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Depressive Symptoms Anxiety Disorders | Behavioral: psychotherapy via asynchronous message |
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 |

- Behavioral: psychotherapy via asynchronous message
Behavioral psychotherapy delivered by asynchronous message using the Talkspace application
- 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.
- 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.
- Mean number of words sent from patient to therapist [ Time Frame: Up to 52 weeks ]Word counts of the words contained within messages sent
- Mean number of words sent from therapist to patient [ Time Frame: Up to 52 weeks ]Word counts of the words contained within messages sent

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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 |
Inclusion Criteria:
- Diagnosed Depression and/or Anxiety Disorder
Exclusion Criteria:
- Any psychosis related symptoms or disorders

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
Principal Investigator: | Matteo Malgaroli, PhD | New York University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
technology messaging psychotherapy depression anxiety telehealth |
Depression Anxiety Disorders Behavioral Symptoms Mental Disorders |