RECRUITING

Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

Conditions

Post-Traumatic Stress Disorder (PTSD)Post Traumatic Stress Disorder (PTSD)Oxytocin Relational Problems Brief Cognitive Behavioral Conjoint Therapy Veterans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among Veterans. Pharmacological augmentation of bCBCT with intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve the efficacy of bCBCT. The purpose of this randomized placebo-controlled trial is to compare the clinical and functional outcomes of bCBCT augmented with intranasal oxytocin (bCBCT + OT) versus bCBCT plus placebo (bCBCT + PL). The investigators will also explore potential mechanisms of action: communication, empathy, and trust.

Official Title

A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

Quick Facts

Study Start:2024-10-28

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06194851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5) no less than 3 months after the index trauma occurred (to allow for potential natural recovery) 2. Be on a stable psychoactive medication regimen for at least 2 months (if eligible) 3. Veteran must be enrolled and eligible to receive care at the VASDHS 4. If able to become pregnant, have a highly sensitive negative urine pregnancy test at study entry and prior to each medication administration during treatment, and agree to use effective birth control methods from study entry until conclusion of treatment to prevent pregnancy. Pregnancy testing can be waived on a case-by-case basis with PI approval. The ability to become pregnant is defined as: assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Effective birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barrier contraception method (e.g., male or female condoms, diaphragm, cap), or vasectomized sole sexual partner. 5. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5) 6. Be married, or cohabitating for at least 6 months 7. Willing to be randomized into both treatment conditions 8. Agree to have assessment and treatment sessions audio/video recorded 9. Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study 10. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)	11. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT) and Drug Abuse Screening Test (DAST) 12. Any current uncontrolled psychotic disorder in either member of the couple as assessed by the Prime Screen-Revised (PS-R) 13. Positive screen (7+) for borderline personality disorder (BPD) in either member of the couple as assessed by the MacLean Screening Instrument for BPD 14. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS) 15. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy 16. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in the past year 17. Pregnancy, breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception (listed above and for PTSD+ Veteran only). 18. Uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (systolic BP \>130 or diastolic BP \> 80 mm Hg) as assessed by self-report and verified with VA chart review. All veterans will also complete a blood pressure reading within a week of completed informed consent/baseline assessment appointment via the strategy that they find most preferable-(1) via an in-person BP reading by a trained professional at VA, (2) via telehealth using a device sent to their home by our research team, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate, (3) via a reading at their local provider's clinic or pharmacy with a BP kiosk (after which they would meet with study staff via telehealth to have the medical record or photo documentation of the reading with time and date visually verified); or (4) via telehealth with their own BP monitor at home while following study instructions for the most accurate reading, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate. Any potential participants for whom we have elevated concern about safety of intranasal oxytocin (per chart review of ongoing risk factors, health history, and concomitant medications) after consulting with our psychiatrist will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment to rule out uncontrolled hypotension or hypertension. 19. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception listed above. A highly sensitive negative urine pregnancy test must be verified visually by research staff at study entry via telehealth or in-person at the Veterans Medical Research Foundation. Research staff will also visually verify a negative pregnancy test result via telehealth prior to each medication administration during treatment. Veteran must also verbally confirm that they completed the test themselves that day. Pregnancy testing can be waived on a case-by-case basis with PI approval. 20. Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.

Inclusion Criteria

Exclusion Criteria

1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
2. Be on a stable psychoactive medication regimen for at least 2 months (if eligible)
3. Veteran must be enrolled and eligible to receive care at the VASDHS
4. If able to become pregnant, have a highly sensitive negative urine pregnancy test at study entry and prior to each medication administration during treatment, and agree to use effective birth control methods from study entry until conclusion of treatment to prevent pregnancy. Pregnancy testing can be waived on a case-by-case basis with PI approval. The ability to become pregnant is defined as: assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Effective birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barrier contraception method (e.g., male or female condoms, diaphragm, cap), or vasectomized sole sexual partner.
5. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5)
6. Be married, or cohabitating for at least 6 months
7. Willing to be randomized into both treatment conditions
8. Agree to have assessment and treatment sessions audio/video recorded
9. Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study
10. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)

11. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT) and Drug Abuse Screening Test (DAST)
12. Any current uncontrolled psychotic disorder in either member of the couple as assessed by the Prime Screen-Revised (PS-R)
13. Positive screen (7+) for borderline personality disorder (BPD) in either member of the couple as assessed by the MacLean Screening Instrument for BPD
14. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
15. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
16. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in the past year
17. Pregnancy, breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception (listed above and for PTSD+ Veteran only).
18. Uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (systolic BP \>130 or diastolic BP \> 80 mm Hg) as assessed by self-report and verified with VA chart review. All veterans will also complete a blood pressure reading within a week of completed informed consent/baseline assessment appointment via the strategy that they find most preferable-(1) via an in-person BP reading by a trained professional at VA, (2) via telehealth using a device sent to their home by our research team, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate, (3) via a reading at their local provider's clinic or pharmacy with a BP kiosk (after which they would meet with study staff via telehealth to have the medical record or photo documentation of the reading with time and date visually verified); or (4) via telehealth with their own BP monitor at home while following study instructions for the most accurate reading, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate. Any potential participants for whom we have elevated concern about safety of intranasal oxytocin (per chart review of ongoing risk factors, health history, and concomitant medications) after consulting with our psychiatrist will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment to rule out uncontrolled hypotension or hypertension.
19. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception listed above. A highly sensitive negative urine pregnancy test must be verified visually by research staff at study entry via telehealth or in-person at the Veterans Medical Research Foundation. Research staff will also visually verify a negative pregnancy test result via telehealth prior to each medication administration during treatment. Veteran must also verbally confirm that they completed the test themselves that day. Pregnancy testing can be waived on a case-by-case basis with PI approval.
20. Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.

Contacts and Locations

Study Contact

Leslie A Morland, PsyD

CONTACT

(619) 497-8406

Leslie.Morland@va.gov

Lauren M Sippel, PhD

CONTACT

(802) 291-2394

Lauren.Sippel@va.gov

Principal Investigator

Leslie A. Morland, PsyD

PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Lauren M. Sippel, PhD

PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Leslie A. Morland, PsyD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA
Lauren M. Sippel, PhD, PRINCIPAL_INVESTIGATOR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-10-28

Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

Post Traumatic Stress Disorder (PTSD)
Oxytocin
Relational Problems
Brief Cognitive Behavioral Conjoint Therapy
Veterans

Additional Relevant MeSH Terms

Post-Traumatic Stress Disorder (PTSD)