Post-Traumatic Stress Disorder (PTSD)Phase 2CBCT-OT RCTNCT06194851
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
A Phase 2 study testing Oxytocin nasal spray, Saline nasal spray and Brief Cognitive-Behavioral Conjoint Therapy in people with Post-Traumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
Trial summary
Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder (PTSD)
- What is being tested?
- Oxytocin nasal spray, Saline nasal spray and Brief Cognitive-Behavioral Conjoint Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be enrolled and eligible to receive care at the VASDHS
- 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)
- Be married, or cohabitating for at least 6 months
- Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL)
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- Agree to have assessment and treatment sessions audio/video recorded
- Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjoint therapy during the treatment portion of the study
- Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)
Who cannot join
- 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)74 and Drug Abuse Screening Test (DAST)75
- Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined following case consult by PI or other clinician.
- Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
- Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
- 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
- Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure <100 mm Hg) or hypertension (systolic BP >130 or diastolic BP > 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion to be determined in collaboration with study physician following completion of physician's one-on-one appointment with Veteran and review of all relevant information (e.g., risk factors, health history, concomitant medications, etc.) from Veteran's VA medical record and study screening/assessment processes including selfreport measures and blood pressure measurement. Additionally, Veterans for whom the study physician has elevated concern, will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment.
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- Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76. Exclusion to be determined following case consult by PI or other clinician.
- Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception. If able to become pregnant, Veteran must have a highly sensitive negative urine pregnancy test verified visually via telehealth or in-person at the Veterans Medical Research Foundation by research staff at study entry and prior to each medication administration during treatment. Veteran must verbally confirm that they completed the test themselves that day. Veteran must also agree to use an effective birth control method from study entry until conclusion of treatment to prevent pregnancy. 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.
- Pregnancy tests will be purchased by the study and mailed to Veteran unless PI has approved waiver of testing requirement.
- Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Leslie A Morland, PsyD, 619-497-8406, Leslie.Morland@va.gov
Leslie A. Morland, PsyD
About this study
Official title: A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder (PTSD)
- Being tested
- Oxytocin nasal spray, Saline nasal spray, Brief Cognitive-Behavioral Conjoint Therapy
- Keywords
- Post Traumatic Stress Disorder (PTSD), Oxytocin, Relational Problems, Brief Cognitive Behavioral Conjoint Therapy, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Also called Pitocin
Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Saline nasal sprayDrug
Veteran participants will self-administer 40 IU of the placebo (intranasal saline spray) 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint TherapyBehavioural
Also called bCBCT
Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
| Study group | Role | What they receive |
|---|---|---|
| Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin | Experimental | Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin. Receives: Drug: Oxytocin nasal spray; Behavioral: Brief Cognitive-Behavioral Conjoint Therapy |
| Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo | Placebo comparator | Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution. Receives: Drug: Saline nasal spray; Behavioral: Brief Cognitive-Behavioral Conjoint Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnosis and severity change
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity. CAPS-5 will be completed by veterans with PTSD only.
Measured: Baseline - 6-months post treatment
Secondary outcomes (1)
Relationship satisfaction
The Couples Satisfaction Index (CSI-32). The CSI-32 is a 32-item self-report survey that measures romantic relationship satisfaction. The first item measures the overall happiness of the relationship on a 7-point scale (0 = Extremely unhappy to 6 = Perfect). The other 31 items capture satisfaction, quality, and happiness of the relationship on 6-point scales (0 to 5) with varying response options. Total CSI-32 scores range from 0 to 161 with higher scores indicating greater relationship satisfaction. Scores below 104.5 indicate clinical relationship distress. CSI-32 will be completed by both partners.
Measured: Baseline - 6-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start28 Oct 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible dyads will be randomized in a stratified 1:1 manner to the oxytocin or placebo condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie A. Morland, PsyD, Principal investigator, VA San Diego Healthcare System, San Diego, CALauren M. Sippel, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194851
- Sponsor's protocol ID
- D4776-R
- Acronym
- CBCT-OT RCT
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sippel LM, Wachsman TR, Kelley ME, Knopp KC, Khalifian CE, Maglione JE, Glynn SM, Macdonald A, Monson CM, Flanagan JC, Holtzheimer PE, Morland LA. Design of a randomized clinical trial of brief couple therapy for PTSD augmented with intranasal oxytocin. Contemp Clin Trials. 2024 Jun;141:107534. doi: 10.1016/j.cct.2024.107534. Epub 2024 Apr 12.
PubMed 38614447
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT06194851
- Acronym / sponsor ID
- CBCT-OT RCT / D4776-R
- Conditions
- Post-Traumatic Stress Disorder (PTSD)
- Keywords
- Post Traumatic Stress Disorder (PTSD), Oxytocin, Relational Problems, Brief Cognitive Behavioral Conjoint Therapy, Veterans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible dyads will be randomized in a stratified 1:1 manner to the oxytocin or placebo condition.
| Arm | Type | Receives |
|---|---|---|
| Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin | Experimental | Drug: Oxytocin nasal spray, Behavioral: Brief Cognitive-Behavioral Conjoint TherapyCouples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin. |
| Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo | Placebo comparator | Drug: Saline nasal spray, Behavioral: Brief Cognitive-Behavioral Conjoint TherapyCouples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be enrolled and eligible to receive care at the VASDHS
- 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)
- Be married, or cohabitating for at least 6 months
Key exclusion criteria (11 listed)
- 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)74 and Drug Abuse Screening Test (DAST)75
- Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined following case consult by PI or other clinician.
- Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
- Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayAlso: PitocinVeteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session. | Drug | Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin |
| Saline nasal sprayVeteran participants will self-administer 40 IU of the placebo (intranasal saline spray) 30 minutes before the start of each bCBCT session. | Drug | Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo |
| Brief Cognitive-Behavioral Conjoint TherapyAlso: bCBCTEight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. | Behavioural | Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin, Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo |
Primary outcome
PTSD diagnosis and severity change
Time frame: Baseline - 6-months post treatment
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity. CAPS-5 will be completed by veterans with PTSD only.
1 secondary outcome
Relationship satisfaction
Time frame: Baseline - 6-months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 38614447Sippel LM, Wachsman TR, Kelley ME, Knopp KC, Khalifian CE, Maglione JE, Glynn SM, Macdonald A, Monson CM, Flanagan JC, Holtzheimer PE, Morland LA. Design of a randomized clinical trial of brief couple therapy for PTSD augmented with intranasal oxytocin. Contemp Clin Trials. 2024 Jun;141:107534. doi: 10.1016/j.cct.2024.107534. Epub 2024 Apr 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray, Saline nasal spray and Brief Cognitive-Behavioral Conjoint Therapy in people with Post-Traumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie A Morland, PsyD ((619) 497-8406, Leslie.Morland@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnosis and severity change (time frame: Baseline - 6-months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.