Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Intranasal administration of Oxytocin (OT) has been found to improve social communication skills and encoding of social cues. Studies indicate that the provision of OT enhances the ability to develop trust 1, to improve the benefits of social support during social stress induction tasks 2 and to increase positive communication during couples' conflict discussions

3. These studies, and many others, point to the potential beneficial effects of OT as a facilitator of relationship-focused processes such as psychotherapy. Studies assessing the effect of OT as a possible outcome enhancer in psychotherapy for clinical populations are scarce, and their findings are largely inconsistent 4. Reasons for this state of affairs include the complexity of recruitment in this population; the provision of single-dose OT, which tends to cause a lower and insufficient effect 5; and methodological constraints, such as the lack of a control group 6 or insufficient probing of interpersonal factors 7.

In this study we intend to overcome these constraints by evaluating the impact of intranasal administration of OT in patients suffering from acute stages of anxiety and depression disorders and undergoing intensive, relationship-focused psychotherapy during psychiatric hospitalization. One-hundred-and-twenty admitted patients with anxiety and depression disorders will be randomized and double-blindly allocated to two groups: (a) psychotherapy + OT (n=60), and (b) psychotherapy + placebo (n=60). Patients will be followed for three weeks, beginning at the start of their hospitalization, and will be assessed for the severity of their anxiety and depression symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal OT will be administered twice a day.

This study can provide insights regarding the potential involvement of OT in the trajectories leading to the production of detectable changes in brain activity following psychotherapy. Additionally, it can support the development of an integrating model combining recent findings in psychotherapy research pertaining to the significant role of therapeutic alliance in psychotherapy outcome, and findings from neuroimaging studies. Finally, provision of OT as a psychotherapy enhancer can facilitate a rapid therapeutic response and subsequently replace aggressive psychiatric medication usage, needed to create a rapid decrease of distress during psychiatric admissions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shalvata Mental Health Center
• Treatments: Ethanol; Glycerol; Oxytocin; Sorbitol

Criteria

Inclusion Criteria:

• Age: 18+

• Diagnosis: Transdiagnostic (e.g. depression, anxiety disorders, OCD, personality disorders, PTSD, etc.).

• Expected length of hospitalization of at least 4 weeks

• A physical and psychiatric evaluation will be conducted in admission to hospital

Exclusion Criteria:

• Pregnancy (bHCG levels will be tested in fertile-aged female patients)

• Patients undergoing ECT

• Substance abuse comorbidity (not including cigarette smoking)

• Psychotic, AS or mental retardation spectrum disorders

• Potential suicidal risk (SSI>12) - requiring approval of treating psychiatrist