Depressive SymptomsNCT03699488
Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study
An observational study of Depressive Symptoms and Anxiety Disorders, run by Talkspace.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Symptoms, Anxiety Disorders
- What is being tested?
- psychotherapy via asynchronous message
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12,980 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals seeking psychotherapy services through digitally-mediated application who present with and are diagnosed with a depression and/or anxiety related disorder.
Who may be able to join
- Diagnosed Depression and/or Anxiety Disorder
Who cannot join
- Any psychosis related symptoms or disorders
About this study
Official title: 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.
- Conditions
- Depressive Symptoms, Anxiety Disorders
- Being tested
- psychotherapy via asynchronous message
- Keywords
- technology, messaging psychotherapy, depression, anxiety, telehealth
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapy via asynchronous messageBehavioural
Behavioral psychotherapy delivered by asynchronous message using the Talkspace application
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 52 weeks
Secondary outcomes (2)
Mean number of words sent from patient to therapist
Word counts of the words contained within messages sent
Measured: Up to 52 weeks
Mean number of words sent from therapist to patient
Word counts of the words contained within messages sent
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 12,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talkspace
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, New York University
- Responsible party
- Sponsor
- Investigators
- Matteo Malgaroli, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699488
- Sponsor's protocol ID
- 1001
- Status last verified
- Feb 2019
- First submitted
- 5 Oct 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32532225
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asynchronous Messaging Therapy for Depression and Anxiety: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT03699488
- Acronym / sponsor ID
- 1001
- Conditions
- Depressive Symptoms, Anxiety Disorders
- Keywords
- technology, messaging psychotherapy, depression, anxiety, telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,980 participants (actual)
- Lead sponsor
- TalkspaceIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University, New York University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals seeking psychotherapy services through digitally-mediated application who present with and are diagnosed with a depression and/or anxiety related disorder.
Key inclusion criteria (1 listed)
- Diagnosed Depression and/or Anxiety Disorder
Key exclusion criteria (1 listed)
- Any psychosis related symptoms or disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapy via asynchronous messageBehavioral psychotherapy delivered by asynchronous message using the Talkspace application | Behavioural | – |
Primary outcome
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.
2 secondary outcomes
Mean number of words sent from patient to therapist
Time frame: Up to 52 weeks
Mean number of words sent from therapist to patient
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Derived from this study: PubMed 32532225Hull 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Malgaroli, PhD principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms and Anxiety Disorders, run by Talkspace.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depressive symptoms on the Patient Health Questionnaire - 9 (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.