Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oxytocin nasal spray
DrugVeteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Saline nasal spray
DrugVeteran 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 Therapy
BehavioralEight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal OxytocinExperimental treatment 2 interventions
Group B: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline - 6-months post treatmentSecondary 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.
Time frame
Baseline - 6-months post treatmentOther outcomes
1
Psychosocial functioning
The Brief Inventory of Psychosocial Functioning (B-IPF) is a brief version of the Inventory of Psychosocial Functioning (IPF) that measures functioning impairment across seven domains: intimate relationships, family and parenting, friendships, work, socializing, education, and self-care over the past 30 days. Total scores, ranging from 0 to 100, are calculated as the sum score divided by the total possible score multiplied by 100, with higher scores indicating greater impairment in functioning. B-IPF will be completed by veterans with PTSD only.
Time frame
Baseline - 6-months post treatment2
Trust
The Trust in Close Relationships Scale (TCRS) is a 17-item self-report measure of trust in close relationships, including predictability, dependability, and faith in close others. The TCRS uses a 7-point Likert scale (-3 = Strongly Disagree to 3 = Strongly Agree) to capture one's level of trust in their intimate partner. Total TCRS scores range from -51 to 51, with higher scores indicating higher levels of trust. The TCRS will be completed by both partners.
Time frame
Baseline - 6-months post treatment3
Empathy
The Interpersonal Reactivity Index for Couples (IRIC) is a measure of empathy expressed within romantic relationships. The IRIC is a 28-item self-report assessment in which participants select their responses to each item on a 5-point Likert scale (0 = does not describe me well to 4 = describes very well). Items are divided into four subscales with 7 items each: perspective-taking, fantasy, empathic concern, and personal distress. Total scores on the IRIC range from 0 to 112 with higher scores indicating higher empathy. This measure will be completed by both partners.
Time frame
Baseline - 6-months post treatment4
Communication
The Brief Communication Skills Test (CST) is a self-report measure of communication skills that was created by pulling the positive communication questions from the full CST. Participants rate items on a 7-point scale from 1 (Almost Never) to 7 (Almost Always). Total scores range from 10 to 70, with higher scores indicating more positive communication. This will be completed by both partners.
Time frame
Baseline - 6-months post treatmentSponsors and contacts
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Source ClinicalTrials.gov