Message-Based Psychotherapy and Digital Treatment Sequences for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Talkspace
- 入组人数
- 1,184
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and
排除标准
- •are the same for Phase 1 and Phase
- •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
- •Exclusion Criteria:
- •Under the age of 18
- •Non-English or Spanish speaking
- •Do not meet criteria for a depressive disorder
- •Participants with active suicidal ideation or with a primary diagnosis of psychosis will also be excluded and referred to intensive care.
研究组 & 干预措施
Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2)
Phase 2 participants who respond to Message-Based Psychotherapy (MBP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2).
干预措施: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2)
Phase 2 participants who respond to Video-Chat Psychotherapy (VCP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). VCP consists of weekly psychotherapy appointments that last between 30-45 minutes.
干预措施: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
干预措施: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
干预措施: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). 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.
干预措施: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). 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.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). 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.
干预措施: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). 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.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: High Monetary Incentive (HMI) (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
干预措施: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire (PHQ-9)
时间窗: 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.
Change in Neuro-QOL - Ability to Participate in Social Roles and Activities
时间窗: 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)
时间窗: 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.
次要结局
- Change in Generalized Anxiety Disorder (GAD-7)(Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts)
- Change in Generalized Anxiety Disorder (GAD-7)(Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts)
研究者
Aarthi Padmanabhan
Senior Director of Research
Talkspace