Trial Outcomes & Findings for Message-Based Psychotherapy and Digital Treatment Sequences for Depression (NCT NCT04513080)

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.

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.

Includes participants who participated in the intervention.

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.

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.

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.

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?

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.

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.

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.

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).

Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only).

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.