Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

NCT03566069 | Active Not Recruiting Phase 2

• 1 other identifier: 0023-17-SHA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Mental Illness

Keywords

Oxytocin; Psychotherapy; Depression; Anxiety; Therapeutic working Alliance

Outcome Measures

Primary Outcomes (1)

• Change in Depression and Anxiety Symptoms

  As measured repeatedly by the Hopkins symptoms checklist -short form (HSCL-11) (Lutz, Tholen, Schurch, \& Berking, 2006)

  assessing change over 10 time points, at baseline, twice a week after psychotherapy sessions over a month of intervention and at Follow-Up a month post intervention for each participant

Secondary Outcomes (1)

• Change in Therapeutic Working Alliance

  assessing change over 8 time points (twice a week after psychotherapy sessions) during the month of the intervention for each participant

Other Outcomes (1)

• Change in Attachment dimension

  assessing change over 2 time points, at baseline and and at the end of the intervention for each participant (after 4 weeks)

Study Arms (2)

Experimental Group

EXPERIMENTAL

After a double-blind rabdomization, patients allocated to the experimental group will be followed for four weeks beginning at the start of their hospitalization, after signing a consent form. After completing baseline self-report measurements, they will be assessed for the severity of their 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 (at 08:00 a.m. and at 17:00 p.m.). The experimental group will receive - 32IU (16IU\*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water. OT will be inhaled in two sprays, one in each nostril.The substance for both study groups will be prepared in the hospital pharmacy, (in identical bottles), after randomization that will be conducted by the pharmacist. A month post intervention, patients will complete self-report measurements as part of a follow-up evaluation.

Drug: Intranasal Oxytocin

Placebo Group

PLACEBO COMPARATOR

After a double-blind rabdomization, patients allocated to the placebo group will be followed for four weeks beginning at the start of their hospitalization, after signing a consent form. After completing baseline self-report measurements, they will be assessed for the severity of their symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal Placebo will be administered twice a day (at 08:00 a.m. and at 17:00 p.m.). The placebo group will receive - 32IU (16IU\*2) of Sorbitol, Benzyl, alcohol glycerol, distilled water, meaning all ingredients except for the OT and will be inhaled in two sprays, one in each nostril.The substance for both study groups will be prepared in the hospital pharmacy, (in identical bottles), after randomization that will be conducted by the pharmacist. A month post intervention, patients will complete self-report measurements as part of a follow-up evaluation.

Other: Intranasal Placebo

Interventions

Intranasal Oxytocin DRUG

32IU (16IU\*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water.

Experimental Group

Intranasal Placebo OTHER

32IU (16IU\*2) of Sorbitol, Benzyl, alcohol glycerol.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental health Center

Hod HaSharon, Israel

Location

Related Publications (1)

• Tzur Bitan D, Grossman-Giron A, Sedoff O, Zilcha-Mano S, Nitzan U, Maoz H. A double-edged hormone: The moderating role of personality and attachment on oxytocin's treatment facilitation effect. Psychoneuroendocrinology. 2023 May;151:106074. doi: 10.1016/j.psyneuen.2023.106074. Epub 2023 Feb 27.

  PMID: 36905736 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

IL (1)