Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Purpose
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.
Condition
- Post-Traumatic Stress Disorder (PTSD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Inclusion criteria for Veterans 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. Inclusion criteria for Partners 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) Inclusion criteria for Veterans and Partner dyads 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)
Exclusion Criteria
Exclusion criteria for Veterans and Partners 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). Exclusion criteria for Veteran receiving medication 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Eligible dyads will be randomized in a stratified 1:1 manner to the oxytocin or placebo condition.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blind, quadruple masking
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin |
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin. |
|
Placebo Comparator Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo |
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
The primary aim of this study is to investigate the effects of Brief Cognitive Behavioral Conjoint Therapy (bCBCT) paired with intranasal oxytocin (OT) versus placebo on PTSD symptoms, intimate relationship satisfaction and psychosocial functioning in a sample of veterans with PTSD (across all measures) and their intimate partners (relationship satisfaction only). The study will also explore the impact of intranasal oxytocin on potential mechanisms of action (i.e., communication skills, empathy, and trust). bCBCT is a modified PTSD-specific cognitive-behavioral psychotherapy attended by the couple that uses close relationships as the vehicle for recovery. Across eight 75-minute sessions, this manualized therapy addresses the patient's PTSD and relationship functioning simultaneously via its focus on PTSD psychoeducation within relationship contexts, communication skills, behavioral approach exercises, and cognitive interventions. Oxytocin is a 9-amino-acid nonapeptide hormone produced by the paraventricular and supraoptic nuclei of the hypothalamus that regulates human emotions, social cognition, and social behaviors. Oxytocin is released to several brain areas, including the amygdala, hypothalamus, hippocampus, insula, and striatum, and effects are mediated by oxytocin receptors found in these regions. Intranasal administration of oxytocin may offer understanding of the causal effects of oxytocin on human behavior. Intranasal oxytocin is safe and easy to administer, with a short half-life that makes it highly suitable for adding to behavioral interventions. Intranasal oxytocin is best known for its widespread effects on affiliative processes and behaviors. For example, intranasal oxytocin increases trust, empathy, generosity, positive communication, and emotional disclosure. Oxytocin also improves social cognition, including emotion recognition and empathic accuracy. The combination of intranasal oxytocin with provision of social support suppresses cortisol release and subjective responses to social stress. Intranasal oxytocin can be conceptualized as a "psychotherapy process catalyst", in that oxytocin could enhance patients' openness to intervention, attention to others' communication, and willingness and ability to develop therapeutic alliance. A recent systematic review of 14 studies of the effects of intranasal oxytocin on PTSD symptoms concluded that there is tentative evidence for the clinical utility of intranasal oxytocin for PTSD, although more studies with chronic administration among clinical samples are needed. The investigators will employ a double blind, placebo-controlled RCT design in which Veterans will receive a dose of oxytocin or placebo before each bCBCT session and complete mid-treatment, post-treatment, 3-month, and 6-month follow-up assessments. Based on the findings from past bCBCT trial and the investigators' recent bCBCT + OT pilot study, the investigators anticipate about 1/3 of the sample will be dual Veterans or the identified Veteran is female. The investigators project an approximate 20-25% attrition rate, resulting in approximately 100 couples completing treatment. Consistent with past trials, to enhance retention, the investigators will ask couples to provide contact information for collateral informants who can reach them if the investigators are unable to do so via their primary contact information. Study personnel will routinely remind couples of appointments via telephone and/or letters and the team will meet weekly to review and problem-solve retention strategies. These are all established procedures implemented from successful prior trials. If successful, the study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.