What side effects are associated with this type of intervention?

Common treatments for depression that align with digital mental health interventions include digital cognitive-behavioral therapy (CBT) and other online psychotherapy platforms. Known side effects of these treatments are generally minimal compared to pharmacotherapy. They may include temporary increases in anxiety or distress as patients confront challenging thoughts and behaviors. Additionally, some users may experience frustration or disengagement due to technical issues or lack of personal interaction. However, these digital interventions are generally well-tolerated and can be effective in improving mental health outcomes.

What prior FDA approvals exist?

The FDA has approved various treatments for depression, primarily focusing on pharmacotherapy and psychotherapy. Traditional pharmacological treatments include SSRIs, SNRIs, and atypical antidepressants. In recent years, there has been a growing interest in digital mental health interventions (DMHIs) for depression, although specific FDA approvals for these digital platforms are less common. These interventions often include cognitive-behavioral therapy (CBT) delivered via apps or online platforms, sometimes supplemented with coaching or therapist support. While the FDA has not specifically approved many digital mental health tools, they are increasingly recognized as effective adjuncts to traditional treatments, particularly for young adults and those with mild to moderate depression.

What other types of research exist?

Promising, novel alternatives to Digital Mental Health Intervention (DMHI) for depression patients in 2024 include: 1) Virtual Reality Therapy: Uses immersive environments to provide exposure therapy and cognitive-behavioral therapy (CBT) in a controlled setting. 2) AI-Powered Chatbots: Provide 24/7 mental health support and CBT-based interventions through conversational agents. 3) Transcranial Magnetic Stimulation (TMS): A non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. 4) Digital Phenotyping: Uses data from smartphones and wearable devices to monitor and predict mental health states, allowing for timely interventions. 5) Psychedelic-Assisted Therapy: Involves the use of substances like psilocybin or MDMA in a controlled therapeutic setting to enhance psychotherapy outcomes.

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Digital Mental Health Intervention for Self-Harm

N/A

Recruiting

Led By David C Mohr, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a digital mental health app for young adults who self-injure but aren't in treatment. The app offers educational content and activities, with some users also getting support from coaches. The goal is to see if the app is feasible for a larger study.

Who is the study for?

This trial is for young adults aged 18-25 who self-injure, are not in therapy, and don't have severe suicidal thoughts or serious mental illnesses like psychosis. Participants must own a smartphone and understand English well enough to consent and use the app.

What is being tested?

The study tests a digital mental health intervention (DMHI) for nonsuicidal self-injury (NSSI). It has three parts: one with just the app, another adds coaching to the app, and a control group gets educational content through the app without interaction.

What are the potential side effects?

Since this is a digital intervention rather than medication, traditional side effects aren't expected. However, users may experience discomfort or emotional distress when engaging with sensitive content related to NSSI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alexian Brothers Assessment of Self-Injury - Methods checklist

Alexian Brothers Urges to Self-Injure Scale

Secondary study objectives

Borderline Evaluation of Severity Over Time

Depression Symptom Inventory - Suicidality Subscale

Generalized Anxiety Disorder-7

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Self-guided digital intervention for NSSIExperimental Treatment1 Intervention

Group II: Digital intervention for NSSI with coachingExperimental Treatment1 Intervention

The self-guided digital intervention for NSSI will consist of 8 weekly modules containing psychoeducation and skill-based practice, and daily ecological momentary assessments. All content is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. This arm will additionally receive lightweight coaching which consists of a one 20-30 minute engagement call at the beginning of treatment. Thereafter, coaches will check in with participants via medium of participants choice twice per week and respond to patient texts, calls, or emails.

Group III: Active controlActive Control1 Intervention

The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacological approaches like antidepressants, which work by altering neurotransmitter levels to improve mood, and psychotherapeutic approaches such as Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT), which focus on changing negative thought patterns and improving interpersonal relationships. Digital Mental Health Interventions (DMHI) provide mental health support through digital platforms, potentially with coaching, to increase accessibility and reduce stigma. These interventions are particularly beneficial for young adults who are comfortable with technology and may be hesitant to seek traditional in-person therapy.

Development of a Framework for the Implementation of Synchronous Digital Mental Health: Realist Synthesis of Systematic Reviews.An internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial.Digital Interventions for Generalized Anxiety Disorder (GAD): Systematic Review and Network Meta-Analysis.