Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness

NCT06332066 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 0046-24-COM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain.

Conditions

Mental Health Therapists

Outcome Measures

Primary Outcomes (1)

• Attunement and Responsiveness towards patients

  PEAR; Snyder \& Silberschatz, 2017 - The Patient's Experience of Attunement and Responsiveness Scale

  3 weeks

Secondary Outcomes (3)

• Attachment with Therapist

  3 weeks

• Working Alliance with Therapist

  3 weeks

• Patient Symptoms

  3 weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

24IU (12IU\*2) of Oxytocin, Sorbitol, Benzyl, alcohol glycerol, distilled water.

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

24IU (12IU\*2) of Sorbitol, Benzyl, alcohol glycerol, distilled water.

Drug: Oxytocin nasal spray

Interventions

Oxytocin nasal spray DRUG

Intranasal OT will be performed using a spray containing 24IU (12IU administered to each nostril), sorbitol, benzyl, alcohol glycerol, distilled water. Dosage and administration method was determined by standard OT studies instructions and guidelines. The substance will be prepared immediately after randomization by an external preparation and delivered and stored until administration under required conditions. The nasal spray will be self administered, with nursing staff supervising for proper administration of substance, and for supervision of side effects.

Oxytocin; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychotherapist (psychologists, psychiatrists, social workers, dieticians, and art therapists in different stages of seniority and training) in adult clinic and eating disorder clinic , who encounter patients for individual therapy will be included.

You may not qualify if:

• Psychotherapists self-declaring pregnancy or breastfeeding.
• Patients coming for regular therapy once or twice a week
• Patients leaving treatment at time of trial.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• Clalit Health Services: collaborator

Study Sites (1)

Mental Health Clinic, Teradion

Misgav Regional Council, Israel

Location

Central Study Contacts

Ayelet Nir, MA

CONTACT

972-54-5705558; ayelinir@zahav.net.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 27, 2024
• Study Start: May 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

IL (1)