Clinical trial NCT04513080: Message-Based Psychotherapy and Digital Treatment Sequences for Depression
Official title: Message-Based Psychotherapy and Digital Treatment Sequences for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Study Adherence
Depressive Disorder
Lead sponsor: Talkspace
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2020-08-14
Enrollment: 973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

Brief summary: This partnership between Talkspace and the 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 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.

Eligibility 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 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.

Primary outcomes:
measure: Change in Neuro-QoL - Ability to Participate in Social Roles and Activities
timeFrame: Change from Baseline Neuro-QoL at 6 weeks and 12 weeks after treatment starts
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder (GAD-7)
timeFrame: Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts
Other outcomes:
measure: Expectations about Treatment (TRS)
timeFrame: Baseline
measure: Experience of Care and Health Outcomes Survey (ECHO)
timeFrame: 12 weeks after treatment starts
measure: Working Alliance Inventory (WAI)
timeFrame: 12 weeks after treatment starts
measure: Tailoring Variable - Clinician-Administered PHQ-9
timeFrame: 6 weeks after treatment starts
measure: Treatment Use Variables
timeFrame: 12 weeks after treatment starts
measure: Treatment Use Variables
timeFrame: 12 weeks after treatment starts
measure: Treatment Use Variables
timeFrame: 12 weeks after treatment starts
Locations:
city: New York
country: United States
facility: Talkspace
state: New York
Study officials:
References:
citation: Arean P, Hull D, Pullmann MD, Heagerty PJ. Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based psychotherapy for depression compared with telepsychotherapy. BMJ Open. 2021 Nov 2;11(11):e046958. doi: 10.1136/bmjopen-2020-046958.