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

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

How is the drug oxytocin unique in treating self-harm?

Oxytocin is unique in treating self-harm because it is a hormone that influences social interactions and feelings of belonging, which are often disrupted in individuals who self-harm. Unlike other treatments, oxytocin may help improve social connectedness and emotional support, potentially reducing the risk of self-harm. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will reduce self-dehumanization using a novel re-humanization condition and compare this group to a control group to analyze the pathway between higher perceptions of self-dehumanization, suicidal ideation, and changes in oxytocin concentrations. It is hypothesized that participants randomly assigned to the re-humanized condition will exhibit decreases in suicidal ideation and increases in oxytocin concentrations as compared to the control condition, which will not display significant changes. Further, we will explore if the magnitude of the oxytocin response will partially mediate the change in suicidal ideation.

Eligibility Criteria

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

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

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

Exclusion Criteria

Participation in the Self-Dehumanized Study by this study team

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

Phobia of needles (trypanophobia)

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Serum oxytocin concentrations in current and recent suicide survivors are lower than in healthy controls. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Oxytocin plasma levels in psychiatric patients with and without recent suicide attempt. [2012]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal oxytocin in the treatment of autism spectrum disorders: a review of literature and early safety and efficacy data in youth. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Unextracted plasma oxytocin levels decrease following in-laboratory social exclusion in young adults with a suicide attempt history. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Suicide attempt and future risk of cancer: a nationwide cohort study in Sweden. [2022]