Anxiety Disorders Clinical Trial
Official title:
Asynchronous Messaging Therapy for Depression and Anxiety: A Longitudinal Study
| 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 |
| Verified date | February 2019 |
| Source | Talkspace |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Talkspace | Columbia University, New York University |
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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