An interventional study of Message-based psychotherapy (MBP) and Video-chat Psychotherapy (VCP) in Depression and Anxiety, sponsored by Talkspace. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Talkspace · Not applicable, Interventional, and Treatment
This study is concerned with evaluating an innovative care delivery platform that is becoming widely available but has not been adequately evaluated in a clinical trial. Primarily, this study is concerned with whether text based care is clinically effective, and if that effect is a function of (1) intervention intensity, (2) timeliness and match of therapeutic recommendations and (3) more stable mood and function over time. Based on the existing, yet limited data in the field, there is evidence to suggest that more frequent encounters with a psychotherapist results in better treatment adherence and faster and more stable response to treatment.
Mobile psychotherapies have been shown to be reliable and effective platforms for delivering evidence-based psychotherapies, and have the potential to reach millions of lives. Several recent randomized clinical trials demonstrate that mobile psychotherapy is effective for mild to moderate depression. These studies also demonstrate that mobile psychotherapy overcomes transportation, time, and stigma barriers for minority and rural individuals. These interventions are found to be culturally relevant and avoid the stigma concerns faced by many minorities and immigrant populations and improve access for those who are too physically disabled to leave home for in-person treatment. Available platforms range from fully self-guided treatment, text-based care, and telephone based psychotherapy. Although self-guided care may be the most cost efficient method of care, recent research shows that this is a highly under-utilized form of care and in soon to be released publication from our group, most patients find this a less appealing form of treatment because of the lack of accountability of the treatment and motivational issues that are a consequence of these illnesses. Indeed, other work suggests that consumer internal resources such as motivation fatigue and illness burden impact engagement with self-guided treatment. Although there is a population to which self-guided treatment may be appealing, in the broader context, access to a coach or expert is needed for these to be effective models of care.
Text-based care however is becoming a widely popular and available form of psychotherapy delivery. Part of the appeal of text-based care is that consumers can access care when they need and at their convenience, and may be able to have more frequent contact with their therapists over the course of treatment. Telephone based psychotherapy is a well-established form of psychotherapy delivery, with several meta-analyses demonstrating not only clinical equivalency with face-to-face psychotherapy, but better adherence to treatment. However, most telephone-based psychotherapy is delivered in a traditional manner, with one-hour, weekly appointments. Although this is an effective manner of care, it still requires that consumers set aside time during the week to receive care and does not allow for in-the-moment care.
Conceptually, text-based care has many potential therapeutic advantages over traditionally delivered telephone-based care. This model of care is similar to Ecological Momentary Intervention (EMI). This intervention model is based on the theory that interventions have their biggest clinical impact when the consumer is at their greatest level of receptivity, and through better timing and tailoring, improve the consumer's readiness to change, self-efficacy to implement the intervention and great behavioral activation in goal directed behavior.
This study is concerned with evaluating an innovative care delivery platform that is becoming widely available but has not been adequately evaluated in a clinical trial. Primarily, this study is concerned with whether text based care is clinically effective, and if that effect is a function of (1) intervention intensity, (2) timeliness and match of therapeutic recommendations and (3) more stable mood and function over time. Based on the existing, yet limited data in the field, there is evidence to suggest that more frequent encounters with a psychotherapist results in better treatment adherence and faster and more stable response to treatment.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 83 is close to the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Talkspace is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Message-based psychotherapy (MBP)
Behavioral: Video-chat Psychotherapy (VCP)
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.
Video Chat Only (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.
Change in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a 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.
Time frame: Change from Baseline PHQ-9 each week for 12 weeks after treatment starts and at 6 months after treatment starts
Change in Generalized Anxiety Disorder (GAD-7)
To assess for co-occurring anxiety, we will use the GAD-7, a 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.
Time frame: Change from Baseline GAD-7 each week for 12 weeks after treatment starts and at 6 months after treatment starts
Plan to share: Yes — Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.
Ran from Feb 2020 to primary completion in Nov 2020, 8 months.
Of 96 industry-sponsored interventional studies with no phase under Depression, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 8 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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