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Psychotherapy for Depression

N/A

Waitlist Available

Research Sponsored by Talkspace

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after treatment starts

Awards & highlights

Study Summary

This trial will compare the effectiveness of two types of depression treatment - weekly therapy and unlimited texting therapy. The goal is to see which works better and to create a new product that can tailor treatment intensity based on the needs of future patients.

Who is the study for?

This trial is for adults in the U.S. who have been diagnosed with depression by a Talkspace clinician and score at least 10 on the PHQ-9 screening, indicating moderate to severe symptoms. It's open to English or Spanish speakers but not for those under 18, without depression as a primary diagnosis, actively suicidal, or primarily psychotic.Check my eligibility

What is being tested?

The study compares different formats of psychotherapy: unlimited text-based therapy (MBP), MBP with monthly video chats (Premium Plan), and MBP with weekly video chats (Ultimate Plan) against traditional once-a-week video-chat psychotherapy (VCP). It aims to find the most effective treatment sequence for those not improving.See study design

What are the potential side effects?

Since this trial involves psychotherapy interventions rather than medication, side effects may include emotional discomfort due to discussing personal issues. However, there are no physical side effects like you would expect from drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline neuro-qol at 6 weeks and 12 weeks after treatment starts

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline neuro-qol at 6 weeks and 12 weeks after treatment starts

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline neuro-qol at 6 weeks and 12 weeks after treatment starts for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Neuro-QoL - Ability to Participate in Social Roles and Activities

Change in Patient Health Questionnaire (PHQ-9)

Secondary outcome measures

Change in Generalized Anxiety Disorder (GAD-7)

Other outcome measures

Expectations about Treatment (TRS)

Experience of Care and Health Outcomes Survey (ECHO)

Tailoring Variable - Clinician-Administered PHQ-9

+2 more

Trial Design

10Treatment groups

Experimental Treatment

Group I: Phase 2, Level 2: MBP with weekly VCPExperimental Treatment1 Intervention

Phase 2: This intervention will serve as an augmentation arm for participants who do not respond to either MBP or VCP after 6 weeks of care. Like the Premium Plan, participants will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist.

Group II: Phase 2, Level 2: MBP with monthly VCPExperimental Treatment1 Intervention

Phase 2: This intervention will serve as the "switch arm" for participants who do not respond to VCP by week 6, and one of two augmentation arms for participants who do not respond to MBP. The Premium plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist.

Group III: Phase 2, Level 1: Video-Chat Psychotherapy (VCP)Experimental Treatment1 Intervention

Phase 2: Weekly psychotherapy appointments that last between 30-45 minutes. Participants who do not respond to this model will be randomized to switch (PP) or augment (UP) VCP.

Group IV: Phase 2 Level 1: Message-Based Psychotherapy (MBP)Experimental Treatment1 Intervention

Phase 2 participants who respond to MBP after 6 weeks of care will continue in this condition for another 6 weeks. Participants who do not respond by week 6 will be randomized to one of two augmentation arms, MBP plus monthly video chat (Premium Plan: PP) or MBP plus weekly video chat (Ultimate Plan: UP) for another 6 weeks of care.

Group V: Phase 1, Level 2: MBP with weekly VCPExperimental Treatment1 Intervention

Phase 1 participants who do not show 50% reduction in PHQ9 scores will be randomized to either weekly VCP augmented with unlimited MBP (augmentation arm), monthly VCP with unlimited MBP (switch/minimal augmentation arm).

Group VI: Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP)Experimental Treatment1 Intervention

In Phase 1, participants will be randomized to one of two incentive levels. After randomization to an incentive level, participants will be randomized to either video-chat psychotherapy (VCP) or message-based psychotherapy (MBP). After six weeks of treatment, participants will move to level 2. Those who have made a 50% reduction to PHQ9 scores to their assigned treatment will continue in that same treatment for 6 more weeks.

Group VII: Phase 1, Level 1: Incentive 2 + Message-based psychotherapyExperimental Treatment1 Intervention

Group VIII: Phase 1, Level 1: Incentive 1 + Video-chat psychotherapyExperimental Treatment1 Intervention

Group IX: Phase 1, Level 1: Incentive 1 + Message-based psychotherapyExperimental Treatment1 Intervention

Group X: Phase 1 Level 2: MBP with monthly VCPExperimental Treatment1 Intervention

Phase 1 participants randomized to VCP who do not show 50% reduction in PHQ9 scores will be randomized to either weekly VCP augmented with unlimited MBP (augmentation arm) or monthly VCP with unlimited MBP (switch/minimal augmentation arm).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Message-based psychotherapy (MBP)

2020

N/A

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

TalkspaceLead Sponsor

4 Previous Clinical Trials

23,463 Total Patients Enrolled

2 Trials studying Depression

13,063 Patients Enrolled for Depression

University of WashingtonOTHER

1,738 Previous Clinical Trials

1,843,378 Total Patients Enrolled

84 Trials studying Depression

87,416 Patients Enrolled for Depression

Media Library

Message-based psychotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04513080 — N/A

Depression Research Study Groups: Phase 2 Level 1: Message-Based Psychotherapy (MBP), Phase 1, Level 2: MBP with weekly VCP, Phase 2, Level 2: MBP with monthly VCP, Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP), Phase 1, Level 1: Incentive 1 + Video-chat psychotherapy, Phase 2, Level 1: Video-Chat Psychotherapy (VCP), Phase 1 Level 2: MBP with monthly VCP, Phase 2, Level 2: MBP with weekly VCP, Phase 1, Level 1: Incentive 1 + Message-based psychotherapy, Phase 1, Level 1: Incentive 2 + Message-based psychotherapy

Depression Clinical Trial 2023: Message-based psychotherapy Highlights & Side Effects. Trial Name: NCT04513080 — N/A

Message-based psychotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04513080 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant quota for this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that the trial, initially posted on March 2nd 2020 and recently modified in late March 2022, is currently enrolling 1000 participants at a single location."

Answered by AI

Is there still scope for enrolment in this research project?

"Data on clinicaltrials.gov affirms that this experiment is presently recruiting participants, with initial posting taking place March 2nd 2020 and a latest amendment conducted 3/29 of 2022."

Answered by AI