Rehumanized Intervention for Self-Harm

Overseen By Thomas E Joiner, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Needle phobia, Fasting issues, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if feeling dehumanized (being treated as less than human) is linked to suicidal thoughts and whether enhancing a sense of humanity can help. Participants will either engage in activities designed to boost self-awareness and creativity or discuss political attitudes as a control. Researchers will also examine changes in oxytocin, a hormone related to bonding, to assess its impact on suicidal thoughts. This trial is open to women aged 18 to 40 who feel moderately dehumanized and currently experience suicidal thoughts. Those at severe risk of suicide, with needle phobia, or certain health conditions may not qualify. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve mental health treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this rehumanization intervention is safe?

Research has shown that oxytocin has been safely used in humans for various conditions. Studies indicate it is usually well-tolerated when aiding social behaviors and some mental health issues. For example, research on oxytocin's effect on social interactions found it to be safe. Although oxytocin can cause uterine contractions when used during labor, this study does not focus on that application. Overall, previous studies suggest that oxytocin is generally safe for humans in various situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Rehumanized Intervention for self-harm because it offers a fresh approach by using oxytocin, a hormone known for promoting bonding and reducing stress. Unlike standard treatments like cognitive-behavioral therapy or medication, which often focus on symptom management, this intervention combines multi-sensory activities to enhance body and soul awareness, fostering a deeper sense of personal agency and connection. By integrating reading, writing, and speaking exercises, it taps into creativity and emotional expression, potentially addressing underlying causes of self-harm in a holistic manner.

What evidence suggests that this trial's treatments could be effective for reducing self-dehumanization and suicidal ideation?

Research has shown that oxytocin, often called the "love hormone," might help reduce feelings of dehumanization, which are linked to self-harm and suicidal thoughts. Studies have found that oxytocin can affect how connected people feel to others and may increase feelings of empathy and trust. For those who have experienced trauma, oxytocin can change their perception of threats, potentially lowering anxiety and stress. Early findings suggest that increasing oxytocin levels could reduce suicidal thoughts by enhancing feelings of humanity and connection. This trial will explore the effects of a rehumanized intervention, which includes multi-sensory activities, on reducing harmful thoughts and behaviors. Participants will join either the experimental rehumanized intervention arm or the control intervention arm, which focuses on political attitudes. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing self-harm thoughts or behaviors, who are undergoing rehabilitation and treatment. Specific eligibility criteria details were not provided, so it's unclear who exactly can participate.

Inclusion Criteria

I am a woman with a regular menstrual cycle lasting 26-30 days.

At least a moderate level of self-dehumanization (sum score of 12 or greater) and current suicidal ideation

Exclusion Criteria

Participation in the Self-Dehumanized Study by this study team

Phobia of needles (trypanophobia)

I cannot fast for 10 hours due to a health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a pre-induction fasted blood draw and self-report assessments

1 day

1 visit (in-person)

Intervention

Participants undergo either the re-humanization intervention or control intervention, followed by a post-intervention blood draw and self-report measures

1 day

1 visit (in-person)

Follow-up

Participants are contacted one month later to fill out a brief battery of self-report measures

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin

Trial Overview The study tests a new 'rehumanized' intervention aimed at reducing self-dehumanization against a control group to see if it affects suicidal ideation and oxytocin levels in the blood.

How Is the Trial Designed?

Group I: Rehumanized Intervention Experimental Treatment 4 Interventions

This self-rehumanization intervention will involve a set of multi-sensory activities (i.e., reading, writing, and speaking) to prompt body and soul awareness, agency, connection, and creativity.

Group II: Control Intervention Active Control 4 Interventions

Control Intervention about political attitudes

Oxytocin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06710964

Inducing Self-Dehumanization to Examine Oxytocin and ... The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will induce self-dehumanization ...

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1590441/full

The first study of a mentalizing mediator model in ... This study sought to investigate the psychological and pathophysiological mechanisms underlying the development of self-injury behavior through environmental, ...

3. withpower.com withpower.com/trial/phase-disease-7-2025-78727

Oxytocin for Self-Harm Risk · Info for Participants The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will induce self-dehumanization ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3669921/

Sniffing around oxytocin: review and meta-analyses of trials in ... Here we review and conduct a meta-analysis of OT studies with clinical groups against the background of the scientific evidence on neural and behavioral ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030645302030024X

Intranasal oxytocin as a potential therapeutic strategy in ... Results suggest that intranasal oxytocin modulates threat salience among childhood trauma-exposed individuals and that these effects vary as a function of ...

6. merck.com merck.com/docs/product/safety-data-sheets/ah-sds/Oxytocin%20Formulation_AH_US_EN.pdf

SAFETY DATA SHEET Oxytocin Formulation Environmental precautions. : Avoid release to the environment. Prevent further leakage or spillage if safe to do so. Prevent spreading over a wide area (e.g., ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5374331/

Oxytocin and the Social Brain - PMC - PubMed Central - NIH Efficacy and safety of oxytocin augmentation therapy for schizophrenia: An updated systematic review and meta-analysis of randomized, placebo-controlled trials.

8. mayoclinic.org mayoclinic.org/drugs-supplements/oxytocin-intravenous-route-intramuscular-route/description/drg-20065254

Oxytocin (intravenous route, intramuscular route) Oxytocin can be very useful for helping labor. However, there are certain risks with using it. Oxytocin causes contractions of the uterus. In ...