Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study

February 4, 2019 updated by: Talkspace

Asynchronous Messaging Therapy for Depression and Anxiety: A Longitudinal Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Diagnosed Depression and/or Anxiety Disorder

Exclusion Criteria:

  • Any psychosis related symptoms or disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 52 weeks
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of words sent from patient to therapist
Time Frame: Up to 52 weeks
Word counts of the words contained within messages sent
Up to 52 weeks
Mean number of words sent from therapist to patient
Time Frame: Up to 52 weeks
Word counts of the words contained within messages sent
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talkspace

Collaborators

New York University
Columbia University

Investigators

  • Principal Investigator: Matteo Malgaroli, PhD, New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data is available from October 10, 2018 to October 10, 2019

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety Disorders

Clinical Trials on psychotherapy via asynchronous message

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe