NCT03699488

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,980

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

October 5, 2018

Last Update Submit

February 4, 2019

Conditions

Keywords

technologymessaging psychotherapydepressionanxietytelehealth

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Mean number of words sent from patient to therapist

    Up to 52 weeks

  • Mean number of words sent from therapist to patient

    Up to 52 weeks

Interventions

Behavioral psychotherapy delivered by asynchronous message using the Talkspace application

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosed Depression and/or Anxiety Disorder

You may not qualify if:

  • Any psychosis related symptoms or disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hull TD, Malgaroli M, Connolly PS, Feuerstein S, Simon NM. Two-way messaging therapy for depression and anxiety: longitudinal response trajectories. BMC Psychiatry. 2020 Jun 12;20(1):297. doi: 10.1186/s12888-020-02721-x.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Matteo Malgaroli, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
Time Frame
Data is available from October 10, 2018 to October 10, 2019