Trial · Interventional

CompletedPhase 2Results postedRegistry data

Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin

Short name CBCT+OT

NCTNCT05207436Other id1227284

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 20 participants (actual)
Sponsor: San Diego Veterans Healthcare System · Fed
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 17 Jan 2022
Primary completion: 30 Sept 2022
Completion: 31 Dec 2022
First posted: 26 Jan 2022
Last update posted: 10 Jul 2023
Conditions: Post Traumatic Stress Disorder · Relational Problems

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20222023

Ph 2
CBCT+OT
NCT05207436
17 Jan 2022 to 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In 2019 VA mandated that all Veterans seeking mental health care have access to flexible family mental health services in VA (VHA directive 1163.04). This study aims to respond to this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD symptoms and improve relationship satisfaction for Veterans and their romantic partners. Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on relationship satisfaction are less reliable and robust. Pharmacological augmentation of psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If successful, the proposed study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.

Interventions

Oxytocin nasal sprayDrug
Brief Cognitive-Behavioral Conjoint TherapyBehavioral

Arms1

Experimental
Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT).

Primary outcomes3

Outcomes the sponsor listed as primary.

Couples Satisfaction Inventory-32
Time frame · baseline
Registry description
The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.
Couples Satisfaction Inventory-32
Time frame · immediately after the intervention (approximately 2-months after baseline)
Registry description
The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.
Couples Satisfaction Inventory-32
Time frame · three months post-treatment (approximately 5-months after baseline)
Registry description
The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

Secondary outcomes(6)

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
Time frame · baseline
Registry description
The PCL-5 is a 20-item self-report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist for DSM-5 (PCL-5)
Time frame · immediately after the intervention (approximately 2-months after baseline)
Registry description
The PCL-5 is a 20-item self-report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist for DSM-5 (PCL-5)
Time frame · three months post-treatment (approximately 5-months after baseline)
Registry description
The PCL-5 is a 20-item self-report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Brief Inventory of Psychosocial Functioning
Time frame · baseline
Registry description
The Brief Inventory of Psychosocial Functioning (B-IPF) is a 7-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher scores (range 0 to 100) indicate more functional impairment.
Brief Inventory of Psychosocial Functioning
Time frame · immediately after the intervention (approximately 2-months after baseline)
Registry description
The Brief Inventory of Psychosocial Functioning (B-IPF) is a 7-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher scores (range 0 to 100) indicate more functional impairment.
Brief Inventory of Psychosocial Functioning
Time frame · three months post-treatment (approximately 5-months after baseline)
Registry description
The Brief Inventory of Psychosocial Functioning (B-IPF) is a 7-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher scores (range 0 to 100) indicate more functional impairment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline

Couples Satisfaction Inventory-32

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	103.6	32.17
bCBCT+OT-Partners	87.30	36.70

Primary outcomeMean· immediately after the intervention (approximately 2-months after baseline)

Couples Satisfaction Inventory-32

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	124.67	23.70
bCBCT+OT-Partners	113.44	39.08

Primary outcomeMean· three months post-treatment (approximately 5-months after baseline)

Couples Satisfaction Inventory-32

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	114.38	40.90
bCBCT+OT-Partners	113.0	49.50

Secondary and other outcome results(5)

Secondary outcomeMean· baseline

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	47.78	10.12

Secondary outcomeMean· immediately after the intervention (approximately 2-months after baseline)

PTSD Checklist for DSM-5 (PCL-5)

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	25.44	13.23

Secondary outcomeMean· three months post-treatment (approximately 5-months after baseline)

PTSD Checklist for DSM-5 (PCL-5)

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	31.22	14.94

Secondary outcomeMean· baseline

Brief Inventory of Psychosocial Functioning

Group	Value (score on a scale)	Spread
bCBCT-OT-Veterans	50.49	20.03
bCBCT+OT-Partners	31.22	21.25

Secondary outcomeMean· immediately after the intervention (approximately 2-months after baseline)

Brief Inventory of Psychosocial Functioning

Group	Value (score on a scale)	Spread
bCBCT+OT-Veterans	31.58	27.35
bCBCT+OT-Partners	20.37	14.87

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
bCBCT-OT-VeteranCouples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT). Oxytocin nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each B-CBCT session. Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.	0 / 10	0 / 10	1 / 10
bCBCT-OT-PartnerCouples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT). Oxytocin nasal spray: Veteran participants only. Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.	0 / 10	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * One member of the couple be a Veteran enrolled in the San Diego VA Healthcare System with a Posttraumatic Stress Disorder Checklist-5 score of \> 33, indicating a likely PTSD diagnosis. * Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study * If already on psychoactive medication prior to study referral, Veteran participant must remain on a stable psychoactive medication regimen for at least 45 days. Exclusion Criteria: * Acute suicidality * Psychosis * Active substance use disorder * Severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes) * Uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (\>160/100 mm Hg) * Pregnancy, delivery in the past 6 months, or current breastfeeding * Severe intimate aggression reported by either partner

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