ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03566069
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

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.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Drug: Intranasal Oxytocin Other: Intranasal Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness: A Randomized Controlled Study
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Experimental Group
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
32IU (16IU*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water.

Placebo Comparator: Placebo Group
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
32IU (16IU*2) of Sorbitol, Benzyl, alcohol glycerol.




Primary Outcome Measures :
  1. Change in Depression and Anxiety Symptoms [ Time Frame: 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 ]
    As measured repeatedly by the Hopkins symptoms checklist -short form (HSCL-11) (Lutz, Tholen, Schurch, & Berking, 2006)


Secondary Outcome Measures :
  1. Change in Therapeutic Working Alliance [ Time Frame: assessing change over 8 time points (twice a week after psychotherapy sessions) during the month of the intervention for each participant ]
    As measured by the 6 item Working Alliance Inventory (WAI-6) (Falkenström, Hatcher, Skjulsvik, Larsson, & Holmqvist, 2014)


Other Outcome Measures:
  1. Change in Attachment dimension [ Time Frame: assessing change over 2 time points, at baseline and and at the end of the intervention for each participant (after 4 weeks) ]
    As measured by the self-report measurement of Adult Attachment (Brennan, Clark & Shaver, 1998)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18+
  • Diagnosis: Depression and any anxiety disorders, including OCD.
  • 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)

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT03566069     History of Changes
Other Study ID Numbers: 0023-17-SHA
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Shalvata Mental Health Center:
Oxytocin
Psychotherapy
Depression
Anxiety
Therapeutic working Alliance

Additional relevant MeSH terms:
Depression
Mental Disorders
Behavioral Symptoms
Ethanol
Oxytocin
Glycerol
Sorbitol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents
Cryoprotective Agents
Protective Agents
Cathartics
Gastrointestinal Agents