Depressive Disorder, Study Adherence
Conditions
Brief summary
This partnership between Talkspace and the University of Washington (UW) ALACRITY Center will determine how effective unlimited text-based psychotherapy for depression is when compared to once-a-week psychotherapy. This study will also determine what the best treatment options are for people who are not responding well to either unlimited texting or weekly psychotherapy. The results of this study will be a new product version of message-based care that can tailor psychotherapy intensity based on the needs of future consumers with depression.
Detailed description
This is a fast track Small Business Innovation Research (SBIR) proposal that will (1) test the effectiveness of daily, message-based psychotherapy (MBP) for depression, compared to traditionally delivered, video-chat psychotherapy (VCP) and (2) develop an evidence-based treatment sequence for those who do not respond to either daily MBP or VCP. Phase 1 consists of a pilot study to determine the best incentive model to retain a sample of people 18 years old and older with depression into a SMART trial. Information from this pilot will inform the retention strategy for Phase 2. Phase 2 is a 12-week, randomized clinical trial using a SMART design to test the following aims: 1. Determine the relative effectiveness of daily MBP compared to weekly VCP in treating symptoms of depression and improving social functioning; 2. For those who fail to respond to 6 weeks of weekly VCP only, determine whether the addition of daily messaging, or a switch to monthly video-chat plus daily messaging improves depression and functional outcomes; and 3. For those who fail to respond to 6 weeks of daily MBP, whether the addition of monthly video-chat or weekly video-chat improves outcomes. Participants will provide data on mood, activity, and functioning, and we will collect data on use of treatment (texts and sessions), and working alliance.
Interventions
BEHAVIORALVideo-Chat Psychotherapy (VCP)
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.
BEHAVIORALMessage-Based Psychotherapy (MBP)
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.
BEHAVIORALMessage-Based Psychotherapy with Monthly Video-Chat Psychotherapy
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.
BEHAVIORALMessage-Based Psychotherapy with Weekly Video-Chat Psychotherapy
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.
BEHAVIORALHigh Monetary Incentive (HMI)
Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.
BEHAVIORALLow Monetary and Alternative Incentive (LMAI)
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.
Sponsors
University of Washington
Talkspace
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
In Phase 1, participants will be masked to the incentive condition to which they are randomized but will be aware of which treatment condition they are receiving.
Intervention model description
Phase 1 will test the effectiveness of two forms of participant retention methods into a SMART (sequential, multiple assignment, randomized). In Phase 1, participants (n=200) will be randomized to an incentive level and then randomized to treatment arms. Phase 2 (n=1000) will be the subsequent SMART design comparing message-based psychotherapy (MBP) to video-chat psychotherapy (VCP) in level 1 and for those who do not respond to care after 6 weeks, those participants will be randomized to either MBP+monthly VCP or MBP+weekly VCP. Arms/Interventions have been adjusted to align with the results for the Phase 2 SMART.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
are the same for Phase 1 and Phase 2. Inclusion Criteria: * 18 years old or older * English or Spanish speaking * Live in the United States * Score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) screening * Receive a diagnosis of depression from a Talkspace intake clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts | 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. |
| Change in Patient Health Questionnaire (PHQ-9) | Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder (GAD-7) | Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts | To assess for co-occurring anxiety, we will use the Generalized Anxiety Disorder-7 (GAD-7), a 7- item screener for generalized anxiety disorder (GAD). Participants rate on a scale of 0-3 how much they have experienced symptoms of GAD in the last two weeks. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The scale is a valid screener for GAD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tailoring Variable - Response to Treatment | 6 weeks after treatment starts | To determine whether patients move to Level 2 treatment (starting at week 6), we will used clinician administered Patient Health Questionnaire-9 (PHQ-9) between weeks 3 to 5 of treatment. Response to treatment was defined as a PHQ-9 score less than 50% of the participant's baseline PHQ-9 score. Response to treatment was also evaluated via therapist feedback. Participants who responded to their Level 1 treatment assignment continued in that condition from weeks 6 to 12. Participants who did not respond to treatment were switched to either MBP with weekly VCP or to MBP with monthly VCP. |
| Treatment Use Variables: Number of Sessions Attended | 12 weeks after treatment starts | Phase 1: Number of distinct days of messaging plus number of live video sessions attended Phase 2: Number of sessions attended, defined as the number of sessions during which the client sent any messages or attended any video sessions, regardless of Level 1 condition (e.g., includes sessions during which participants in VCP only sent messages). |
| Expectations About Treatment: Treatment Rationale Scale (TRS) | Week 1 | Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment. Items are rated on a scale of 0 (not at all) to 10 (very). Total scores range from 0 to 40, with higher scores indicating better outcomes. 1) How logical does your Talkspace treatment seem to you? 2) How confident are you that the treatment will be successful in eliminating your depression? 3) How confident would you be in recommending the treatment to a friend with depression? 4) If you were extremely depressed, would you be willing to undergo such treatment? |
| Treatment Use Variables: Time Between Patient and Psychotherapist Contact | 12 weeks after treatment starts | Time between patient and psychotherapist contact, defined as the number of days from client's Level 1 randomization date to the date of first psychotherapist message or video call. These data were available only for Phase 2. |
| Treatment Use Variables: Number of Messages Sent | 12 weeks after treatment starts | Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only). |
| Experience of Care and Health Outcomes Survey (ECHO) | 10 weeks after treatment starts | The Experience of Care and Health Outcomes Survey (ECHO) items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85. For quality of care, participants rated an adapted version of item 28 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ECHO survey: In the past 4 weeks, using any number from 0 to 10, where 0 is the worst mental health care possible and 10 is the best mental health care possible, what number would you use to rate the mental health care you received from Talkspace? Ratings range from 0 to 10. Higher scores indicate better quality of care received. |
| Working Alliance Inventory-Short Revised (WAI-SR) | 10 weeks after treatment starts | Participants rated therapeutic alliance using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach) evaluating three domains: goals, tasks, and bond. Items are rated on a scale from 1 to 5. Total scores range from 12-60, with higher scores indicating a more effective therapeutic relationship. It is a reliable measure of alliance, with alpha = .92. |
Countries
United States
Participant flow
Recruitment details
Baseline to Week 5: Participated in the Intervention includes the analytic sample for Level 1 analyses. Completed is defined as participants evaluated for Level 2 randomization. Week 6 to Week 12: Phase 1 Completed is defined as having completed the PHQ-9 at any time between weeks 6 to 12. Phase 2 Completed is defined as having completed outcome measures between weeks 6 to 12.
Pre-assignment details
The Participant Flow below shows arms by combination of Level 1 and Level 2 conditions. Sample sizes from baseline to week 5 apply to Level 1 conditions. Sample sizes from week 6 to week 12 apply to Level 2 conditions. Therefore, sample sizes for arms including Level 2 conditions from baseline to week 5 are 0.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) 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. | 423 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) 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. | 427 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. 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. | 55 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. 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. | 54 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) 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. 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. | 52 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) 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. 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. | 54 |
| Total | 1,065 |
Baseline characteristics
| Characteristic | Total | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) | Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Phase 2: Message-Based Psychotherapy (MBP; Level 1) |
|---|---|---|---|---|---|---|---|
| Age, Continuous Phase 1 | 29.72 years STANDARD_DEVIATION 9.54 | 29.20 years STANDARD_DEVIATION 10.04 | 29.48 years STANDARD_DEVIATION 8.89 | 28.91 years STANDARD_DEVIATION 8.86 | 31.25 years STANDARD_DEVIATION 10.35 | — | — |
| Age, Continuous Phase 2 | 33.8 years STANDARD_DEVIATION 10.5 | — | — | — | — | 34.1 years STANDARD_DEVIATION 10.9 | 33.4 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 185 Participants | 16 Participants | 16 Participants | 18 Participants | 15 Participants | 58 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 858 Participants | 36 Participants | 36 Participants | 34 Participants | 39 Participants | 362 Participants | 351 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants | 10 Participants |
| Patient Health Questionnaire-9 (PHQ-9) Phase 1 | 17.15 units on a scale STANDARD_DEVIATION 4.41 | 18.22 units on a scale STANDARD_DEVIATION 4.47 | 16.76 units on a scale STANDARD_DEVIATION 4.6 | 16.22 units on a scale STANDARD_DEVIATION 4.55 | 17.45 units on a scale STANDARD_DEVIATION 3.83 | — | — |
| Patient Health Questionnaire-9 (PHQ-9) Phase 2 | 14.99 units on a scale STANDARD_DEVIATION 4.79 | — | — | — | — | 15.00 units on a scale STANDARD_DEVIATION 4.84 | 14.98 units on a scale STANDARD_DEVIATION 4.75 |
| Race/Ethnicity, Customized Race American Indian/Alaskan Native | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 62 Participants | 4 Participants | 5 Participants | 5 Participants | 3 Participants | 21 Participants | 24 Participants |
| Race/Ethnicity, Customized Race Black or African American | 210 Participants | 3 Participants | 7 Participants | 7 Participants | 3 Participants | 93 Participants | 97 Participants |
| Race/Ethnicity, Customized Race Multiple races | 83 Participants | 6 Participants | 6 Participants | 7 Participants | 9 Participants | 33 Participants | 22 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Prefer not to say | 23 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Prefer to self describe | 33 Participants | 3 Participants | 3 Participants | 4 Participants | 5 Participants | 9 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Unknown or not reported | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 640 Participants | 34 Participants | 31 Participants | 30 Participants | 33 Participants | 253 Participants | 259 Participants |
| Sex/Gender, Customized Gender Female | 733 Participants | 44 Participants | 38 Participants | 42 Participants | 47 Participants | 287 Participants | 275 Participants |
| Sex/Gender, Customized Gender Male | 261 Participants | 8 Participants | 10 Participants | 9 Participants | 3 Participants | 115 Participants | 116 Participants |
| Sex/Gender, Customized Gender Other | 62 Participants | 2 Participants | 4 Participants | 3 Participants | 3 Participants | 23 Participants | 27 Participants |
| Sex/Gender, Customized Gender Unknown or not reported | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 485 | 0 / 484 | 0 / 114 | 0 / 144 | 0 / 126 | 0 / 117 | 0 / 55 | 0 / 54 | 0 / 52 | 0 / 54 | 0 / 10 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 0 / 485 | 0 / 484 | 0 / 114 | 0 / 144 | 0 / 126 | 0 / 117 | 0 / 55 | 0 / 54 | 0 / 52 | 0 / 54 | 0 / 10 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 16 |
| serious Total, serious adverse events | 0 / 485 | 1 / 484 | 0 / 114 | 0 / 144 | 0 / 126 | 0 / 117 | 0 / 55 | 1 / 54 | 0 / 52 | 0 / 54 | 0 / 10 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 16 |
Outcome results
Primary
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.
Time frame: Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts
Population: Phase 2 participants contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Baseline | 39.55 T-score | Standard Deviation 3.93 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Week 6 | 41.65 T-score | Standard Deviation 4.95 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Week 12 | 43.39 T-score | Standard Deviation 6.5 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Baseline | 39.57 T-score | Standard Deviation 4.55 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Week 6 | 42.07 T-score | Standard Deviation 5.47 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Week 12 | 43.11 T-score | Standard Deviation 6.68 |
Comparison: Mean difference comparing difference in average scores from baseline to week 6
Comparison: Mean difference comparing difference in average scores from week 6 to week 12
Primary
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.
Time frame: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
Population: All participants randomized to a Level 2 condition contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 4.25 units on a scale | Standard Deviation 4.15 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.06 units on a scale | Standard Deviation 4.67 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 5.55 units on a scale | Standard Deviation 3.95 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.30 units on a scale | Standard Deviation 4.91 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 5.26 units on a scale | Standard Deviation 3.97 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 3.88 units on a scale | Standard Deviation 4.08 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 10.57 units on a scale | Standard Deviation 5.02 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 14.48 units on a scale | Standard Deviation 5.33 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 9.12 units on a scale | Standard Deviation 6.05 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 9.91 units on a scale | Standard Deviation 5.76 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.14 units on a scale | Standard Deviation 4.72 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.67 units on a scale | Standard Deviation 5.03 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.15 units on a scale | Standard Deviation 5.28 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 14.85 units on a scale | Standard Deviation 4.79 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 9.39 units on a scale | Standard Deviation 5.98 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 10.43 units on a scale | Standard Deviation 5.11 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.09 units on a scale | Standard Deviation 4.32 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.51 units on a scale | Standard Deviation 5.09 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 4.92 units on a scale | Standard Deviation 3.92 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 17.64 units on a scale | Standard Deviation 3.77 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 7.18 units on a scale | Standard Deviation 4.14 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 20.91 units on a scale | Standard Deviation 4.72 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 7.80 units on a scale | Standard Deviation 3.85 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 7.38 units on a scale | Standard Deviation 6.09 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 7.00 units on a scale | Standard Deviation 4.84 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 4.83 units on a scale | Standard Deviation 1.94 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.83 units on a scale | Standard Deviation 4.93 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 6.27 units on a scale | Standard Deviation 4.4 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.59 units on a scale | Standard Deviation 3.74 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 5.42 units on a scale | Standard Deviation 3.42 |
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 12.56 units on a scale | Standard Deviation 4 |
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 7.86 units on a scale | Standard Deviation 3.34 |
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 18.89 units on a scale | Standard Deviation 3.48 |
| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 13.78 units on a scale | Standard Deviation 5.78 |
| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 9.57 units on a scale | Standard Deviation 4.28 |
| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.67 units on a scale | Standard Deviation 4.47 |
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.91 units on a scale | Standard Deviation 3.65 |
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.30 units on a scale | Standard Deviation 4.24 |
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 11.57 units on a scale | Standard Deviation 5.32 |
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.67 units on a scale | Standard Deviation 4.6 |
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 11.33 units on a scale | Standard Deviation 4.97 |
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.83 units on a scale | Standard Deviation 5.64 |
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 14.00 units on a scale | Standard Deviation 5.32 |
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 18.73 units on a scale | Standard Deviation 4.86 |
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 14.29 units on a scale | Standard Deviation 4.82 |
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.23 units on a scale | Standard Deviation 5.07 |
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 10.44 units on a scale | Standard Deviation 6.25 |
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 11.30 units on a scale | Standard Deviation 7.92 |
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 11.00 units on a scale | Standard Deviation 3.16 |
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 10.78 units on a scale | Standard Deviation 5.65 |
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 15.46 units on a scale | Standard Deviation 5.27 |
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 6 | 12.45 units on a scale | Standard Deviation 5.5 |
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Baseline | 16.80 units on a scale | Standard Deviation 5.05 |
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Change in Patient Health Questionnaire (PHQ-9) | Week 12 | 9.64 units on a scale | Standard Deviation 6.55 |
Comparison: Mean difference comparing difference in average scores from baseline to week 6
Comparison: Mean difference comparing difference in average scores from week 6 to week 12
Comparison: Mean difference comparing difference in average scores from baseline to week 6
Comparison: Mean difference comparing difference in average scores from week 6 to week 12
Comparison: Mean difference comparing difference in average scores from baseline to week 6
Comparison: Mean difference comparing difference in average scores from week 6 to week 12
Secondary
Change in Generalized Anxiety Disorder (GAD-7)
To assess for co-occurring anxiety, we will use the Generalized Anxiety Disorder-7 (GAD-7), a 7- item screener for generalized anxiety disorder (GAD). Participants rate on a scale of 0-3 how much they have experienced symptoms of GAD in the last two weeks. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The scale is a valid screener for GAD.
Time frame: Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts
Population: All participants contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 8.70 units on a scale | Standard Deviation 5.12 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 6.98 units on a scale | Standard Deviation 5.66 |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 12.22 units on a scale | Standard Deviation 5.26 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 8.21 units on a scale | Standard Deviation 5.18 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 7.03 units on a scale | Standard Deviation 5.55 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 12.06 units on a scale | Standard Deviation 5.04 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 7.17 units on a scale | Standard Deviation 4.81 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 14.76 units on a scale | Standard Deviation 4.63 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 9.29 units on a scale | Standard Deviation 4.51 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 14.67 units on a scale | Standard Deviation 5.12 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 10.11 units on a scale | Standard Deviation 5.34 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 8.23 units on a scale | Standard Deviation 5.7 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 9.04 units on a scale | Standard Deviation 6.61 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 13.27 units on a scale | Standard Deviation 5.39 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 8.76 units on a scale | Standard Deviation 5.67 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 6 | 8.77 units on a scale | Standard Deviation 5.14 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Baseline | 13.33 units on a scale | Standard Deviation 5.08 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Change in Generalized Anxiety Disorder (GAD-7) | Week 12 | 7.58 units on a scale | Standard Deviation 5.7 |
Other Pre-specified
Expectations About Treatment: Treatment Rationale Scale (TRS)
Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment. Items are rated on a scale of 0 (not at all) to 10 (very). Total scores range from 0 to 40, with higher scores indicating better outcomes. 1) How logical does your Talkspace treatment seem to you? 2) How confident are you that the treatment will be successful in eliminating your depression? 3) How confident would you be in recommending the treatment to a friend with depression? 4) If you were extremely depressed, would you be willing to undergo such treatment?
Time frame: Week 1
Population: Participants providing data on all items of the Treatment Rationale Scale at week 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 24.34 units on a scale | Standard Deviation 9.38 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 26.98 units on a scale | Standard Deviation 8.06 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 26.07 units on a scale | Standard Deviation 7.75 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 25.71 units on a scale | Standard Deviation 8.1 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 25.65 units on a scale | Standard Deviation 7.88 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Expectations About Treatment: Treatment Rationale Scale (TRS) | 24.74 units on a scale | Standard Deviation 7.37 |
Other Pre-specified
Experience of Care and Health Outcomes Survey (ECHO)
The Experience of Care and Health Outcomes Survey (ECHO) items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85. For quality of care, participants rated an adapted version of item 28 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ECHO survey: In the past 4 weeks, using any number from 0 to 10, where 0 is the worst mental health care possible and 10 is the best mental health care possible, what number would you use to rate the mental health care you received from Talkspace? Ratings range from 0 to 10. Higher scores indicate better quality of care received.
Time frame: 10 weeks after treatment starts
Population: Participants randomized to a Level 2 condition contributing data at week 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Experience of Care and Health Outcomes Survey (ECHO) | 7.53 units on a scale | Standard Deviation 1.97 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Experience of Care and Health Outcomes Survey (ECHO) | 8.09 units on a scale | Standard Deviation 1.84 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 5.88 units on a scale | Standard Deviation 2.57 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.11 units on a scale | Standard Deviation 2.62 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.24 units on a scale | Standard Deviation 2.47 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.42 units on a scale | Standard Deviation 2.27 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 8.44 units on a scale | Standard Deviation 1.59 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 5.90 units on a scale | Standard Deviation 3.18 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 8.43 units on a scale | Standard Deviation 1.13 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 5.64 units on a scale | Standard Deviation 2.38 |
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.33 units on a scale | Standard Deviation 2.65 |
| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.63 units on a scale | Standard Deviation 2.2 |
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.11 units on a scale | Standard Deviation 2.15 |
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 4.67 units on a scale | Standard Deviation 2.96 |
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.57 units on a scale | Standard Deviation 1.72 |
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 8.29 units on a scale | Standard Deviation 2.36 |
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 7.25 units on a scale | Standard Deviation 2.66 |
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Experience of Care and Health Outcomes Survey (ECHO) | 6.22 units on a scale | Standard Deviation 1.64 |
Other Pre-specified
Tailoring Variable - Response to Treatment
To determine whether patients move to Level 2 treatment (starting at week 6), we will used clinician administered Patient Health Questionnaire-9 (PHQ-9) between weeks 3 to 5 of treatment. Response to treatment was defined as a PHQ-9 score less than 50% of the participant's baseline PHQ-9 score. Response to treatment was also evaluated via therapist feedback. Participants who responded to their Level 1 treatment assignment continued in that condition from weeks 6 to 12. Participants who did not respond to treatment were switched to either MBP with weekly VCP or to MBP with monthly VCP.
Time frame: 6 weeks after treatment starts
Population: Includes participants assessed for Level 2 randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Tailoring Variable - Response to Treatment | Responded to treatment | 105 Participants |
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 258 Participants |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Tailoring Variable - Response to Treatment | Responded to treatment | 93 Participants |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 243 Participants |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Tailoring Variable - Response to Treatment | Responded to treatment | 15 Participants |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 22 Participants |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Tailoring Variable - Response to Treatment | Responded to treatment | 11 Participants |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 26 Participants |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Tailoring Variable - Response to Treatment | Responded to treatment | 12 Participants |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 25 Participants |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Tailoring Variable - Response to Treatment | Responded to treatment | 17 Participants |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Tailoring Variable - Response to Treatment | Did not respond to treatment | 29 Participants |
Other Pre-specified
Treatment Use Variables: Number of Messages Sent
Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only).
Time frame: 12 weeks after treatment starts
Population: Includes participants who sent any number of messages; excludes participants who sent no messages.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Treatment Use Variables: Number of Messages Sent | 46.42 number of messages | Standard Deviation 55.63 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Treatment Use Variables: Number of Messages Sent | 26.19 number of messages | Standard Deviation 28.64 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Treatment Use Variables: Number of Messages Sent | 38.80 number of messages | Standard Deviation 38.45 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Treatment Use Variables: Number of Messages Sent | 70.33 number of messages | Standard Deviation 76.93 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Treatment Use Variables: Number of Messages Sent | 52.58 number of messages | Standard Deviation 80.27 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Treatment Use Variables: Number of Messages Sent | 109.04 number of messages | Standard Deviation 173.56 |
Other Pre-specified
Treatment Use Variables: Number of Sessions Attended
Phase 1: Number of distinct days of messaging plus number of live video sessions attended Phase 2: Number of sessions attended, defined as the number of sessions during which the client sent any messages or attended any video sessions, regardless of Level 1 condition (e.g., includes sessions during which participants in VCP only sent messages).
Time frame: 12 weeks after treatment starts
Population: Includes participants who sent any number of messages or attended any number of video sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Treatment Use Variables: Number of Sessions Attended | 20.02 sessions | Standard Deviation 16.3 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Treatment Use Variables: Number of Sessions Attended | 16.10 sessions | Standard Deviation 11.71 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Treatment Use Variables: Number of Sessions Attended | 20.63 sessions | Standard Deviation 13 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Treatment Use Variables: Number of Sessions Attended | 70.33 sessions | Standard Deviation 17.26 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Treatment Use Variables: Number of Sessions Attended | 21.32 sessions | Standard Deviation 80.27 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Treatment Use Variables: Number of Sessions Attended | 22.54 sessions | Standard Deviation 173.56 |
Other Pre-specified
Treatment Use Variables: Time Between Patient and Psychotherapist Contact
Time between patient and psychotherapist contact, defined as the number of days from client's Level 1 randomization date to the date of first psychotherapist message or video call. These data were available only for Phase 2.
Time frame: 12 weeks after treatment starts
Population: Phase 2 participants who received a message from a psychotherapist or attended a video session.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Treatment Use Variables: Time Between Patient and Psychotherapist Contact | 0.95 days | Standard Deviation 3.16 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Treatment Use Variables: Time Between Patient and Psychotherapist Contact | 0.93 days | Standard Deviation 1.65 |
Other Pre-specified
Working Alliance Inventory-Short Revised (WAI-SR)
Participants rated therapeutic alliance using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach) evaluating three domains: goals, tasks, and bond. Items are rated on a scale from 1 to 5. Total scores range from 12-60, with higher scores indicating a more effective therapeutic relationship. It is a reliable measure of alliance, with alpha = .92.
Time frame: 10 weeks after treatment starts
Population: Participants randomized to a Level 2 condition contributing data at week 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Working Alliance Inventory-Short Revised (WAI-SR) | 47.70 units on a scale | Standard Deviation 10.65 |
| Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Working Alliance Inventory-Short Revised (WAI-SR) | 49.45 units on a scale | Standard Deviation 9.73 |
| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 38.28 units on a scale | Standard Deviation 14.05 |
| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 37.99 units on a scale | Standard Deviation 14.38 |
| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 41.78 units on a scale | Standard Deviation 12.55 |
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 41.98 units on a scale | Standard Deviation 10.92 |
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 50.56 units on a scale | Standard Deviation 4.53 |
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 40.10 units on a scale | Standard Deviation 17.97 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 49.29 units on a scale | Standard Deviation 9.09 |
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 32.27 units on a scale | Standard Deviation 9.9 |
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 35.78 units on a scale | Standard Deviation 15.43 |
| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 39.69 units on a scale | Standard Deviation 12.16 |
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 34.11 units on a scale | Standard Deviation 13.86 |
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 35.22 units on a scale | Standard Deviation 12.42 |
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 37.86 units on a scale | Standard Deviation 10.22 |
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 48.57 units on a scale | Standard Deviation 12.65 |
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 43.00 units on a scale | Standard Deviation 13.83 |
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Working Alliance Inventory-Short Revised (WAI-SR) | 35.56 units on a scale | Standard Deviation 8.38 |