Message-Based Psychotherapy and Digital Treatment Sequences for Depression

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 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Study Adherence, Depressive Disorder

Being tested

Video-Chat Psychotherapy (VCP), Message-Based Psychotherapy (MBP), Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy, Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy, High Monetary Incentive (HMI)

Medical subject headings

Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Video-Chat Psychotherapy (VCP)Behavioural

  Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety.

• Message-Based Psychotherapy (MBP)Behavioural

  Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies.

• Message-Based Psychotherapy with Monthly Video-Chat PsychotherapyBehavioural

  Message-Based Psychotherapy (MBP) with monthly Video-Chat Psychotherapy (VCP) allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. Therapist and participants schedule their video chat appointment to occur at once a month interval during therapist office hours. The content of these sessions, as well as the MBP portion of care, will be based on CBT, PST or IPT. In Phase 1, this is referred to as "Switch Arm" (for participants assigned to VCP at baseline) or "Minimal Augmentation" (for participants assigned to MBP at baseline). In Phase 2, this is referred to as the "Premium Plan".

• Message-Based Psychotherapy with Weekly Video-Chat PsychotherapyBehavioural

  Message-Based Psychotherapy (MBP) with weekly Video-Chat Psychotherapy (VCP) allows patients access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. Therapists will provide care based on CBT, PST or IPT. In Phase 1, this is referred to as the "Augmentation Arm". In Phase 2, this is referred to as the "Ultimate Plan."

• High Monetary Incentive (HMI)Behavioural

  Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

• Low Monetary and Alternative Incentive (LMAI)Behavioural

  Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change in Neuro-QOL - Ability to Participate in Social Roles and Activities

   Neuro-Quality of Life v1.0 (Neuro-QOL). The Neuro-QOL Ability to Participate in Social Roles and Activities short form item bank is an 8-item patient-rated measure of social functioning. Items focus on difficulty participating in social, family, and work activities, and are rated on a 1 to 5 scale for a total score between 8 and 40. Neuro-QOL scores were transformed into t-scores per the scoring manual; after transformation, total scores range from 24.1 to 60.2. Transformed scores are reported. Higher scores indicate less difficulty participating in social roles and activities. The Neuro-QOL was not distributed in Phase 1.

   Measured: Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts

2. Change in Patient Health Questionnaire (PHQ-9)

   The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (DMS) symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Total scores range from 0-27, with higher scores indicating greater severity of depression.

   Measured: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted14 Aug 2020
2. Study start2 Mar 2020
3. Primary completion14 Jan 2024
4. Study completion14 Jan 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Study AdherenceStudies 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.