Trial Outcomes & Findings for Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin (NCT NCT05207436)
NCT ID: NCT05207436
Last Updated: 2023-07-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
baseline
Results posted on
2023-07-10
Participant Flow
Participant milestones
| Measure |
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).
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.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
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18
|
|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin
Baseline characteristics by cohort
| Measure |
Brief Cognitive Behavioral Conjoint Therapy for PTSD Plus Intranasal Oxytocin
n=20 Participants
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).
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.
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|---|---|
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Age, Continuous
|
34.10 years
STANDARD_DEVIATION 5.45 • n=93 Participants
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Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
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3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
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Region of Enrollment
United States
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20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: baselineThe 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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
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|---|---|---|
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Couples Satisfaction Inventory-32
|
103.6 score on a scale
Standard Deviation 32.17
|
87.30 score on a scale
Standard Deviation 36.70
|
PRIMARY outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
Couples Satisfaction Inventory-32
|
124.67 score on a scale
Standard Deviation 23.70
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113.44 score on a scale
Standard Deviation 39.08
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PRIMARY outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
Couples Satisfaction Inventory-32
|
114.38 score on a scale
Standard Deviation 40.90
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113.0 score on a scale
Standard Deviation 49.50
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SECONDARY outcome
Timeframe: baselinePopulation: Veteran data only; partner PCL-5 not an outcome measure
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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
|
47.78 score on a scale
Standard Deviation 10.12
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—
|
SECONDARY outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)Population: Veterans only
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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
25.44 score on a scale
Standard Deviation 13.23
|
—
|
SECONDARY outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)Population: Veterans only
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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
31.22 score on a scale
Standard Deviation 14.94
|
—
|
SECONDARY outcome
Timeframe: baselineThe 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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
Brief Inventory of Psychosocial Functioning
|
50.49 score on a scale
Standard Deviation 20.03
|
31.22 score on a scale
Standard Deviation 21.25
|
SECONDARY outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
Brief Inventory of Psychosocial Functioning
|
31.58 score on a scale
Standard Deviation 27.35
|
20.37 score on a scale
Standard Deviation 14.87
|
SECONDARY outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)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.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
Brief Inventory of Psychosocial Functioning
|
32.00 score on a scale
Standard Deviation 27.39
|
23.81 score on a scale
Standard Deviation 23.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineThe World Health Organization Quality of Life - BREF - Physical is a 7-item self-report questionnaire assessing an individual's physical health and functioning. Scores range from 0 to 100, with higher scores representing a better outcome
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - Brief (BREF) - Physical
|
50.19 score on a scale
Standard Deviation 9.28
|
42.21 score on a scale
Standard Deviation 9.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)The World Health Organization Quality of Life - BREF - Physical is a 7-item self-report questionnaire assessing an individual's physical health and functioning. Scores range from 0 to 100, with higher scores representing a better outcome
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Physical
|
55.16 score on a scale
Standard Deviation 6.94
|
55.56 score on a scale
Standard Deviation 11.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)The World Health Organization Quality of Life - BREF - Physical is a 7-item self-report questionnaire assessing an individual's physical health and functioning. Scores range from 0 to 100, with higher scores representing a better outcome
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Physical
|
51.98 score on a scale
Standard Deviation 10.58
|
54.02 score on a scale
Standard Deviation 9.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineThe World Health Organization Quality of Life - BREF - Psychological is a 6-item self-report questionnaire that assesses an individual's mental well-being and psychological functioning. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Psychological
|
51.39 score on a scale
Standard Deviation 11.41
|
62.04 score on a scale
Standard Deviation 14.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)The World Health Organization Quality of Life - BREF - Psychological is a 6-item self-report questionnaire that assesses an individual's mental well-being and psychological functioning. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Psychological
|
54.17 score on a scale
Standard Deviation 12.67
|
65.74 score on a scale
Standard Deviation 17.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)The World Health Organization Quality of Life - BREF - Psychological is a 6-item self-report questionnaire that assesses an individual's mental well-being and psychological functioning. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Psychological
|
52.78 score on a scale
Standard Deviation 13.98
|
65.10 score on a scale
Standard Deviation 10.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineThe World Health Organization Quality of Life - BREF - Social is a 3-item self-report questionnaire that assesses an individual's satisfaction with their social relationships. Scores range from 0 to 100, with higher score representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Social
|
47.92 score on a scale
Standard Deviation 20.77
|
50.00 score on a scale
Standard Deviation 23.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)The World Health Organization Quality of Life - BREF - Social is a 3-item self-report questionnaire that assesses an individual's satisfaction with their social relationships. Scores range from 0 to 100, with higher score representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Social
|
65.63 score on a scale
Standard Deviation 20.14
|
62.04 score on a scale
Standard Deviation 27.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)The World Health Organization Quality of Life - BREF - Social is a 3-item self-report questionnaire that assesses an individual's satisfaction with their social relationships. Scores range from 0 to 100, with higher score representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Social
|
57.41 score on a scale
Standard Deviation 18.84
|
66.67 score on a scale
Standard Deviation 23.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineThe World Health Organization Quality of Life - BREF - Environmental is an 8-item self-report questionnaire that assesses an individual's satisfaction with their physical, social, and home environment. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Environment
|
65.28 score on a scale
Standard Deviation 11.63
|
68.06 score on a scale
Standard Deviation 17.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after the intervention (approximately 2-months after baseline)The World Health Organization Quality of Life - BREF - Environmental is an 8-item self-report questionnaire that assesses an individual's satisfaction with their physical, social, and home environment. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Environment
|
72.22 score on a scale
Standard Deviation 11.42
|
72.92 score on a scale
Standard Deviation 16.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: three months post-treatment (approximately 5-months after baseline)The World Health Organization Quality of Life - BREF - Environmental is an 8-item self-report questionnaire that assesses an individual's satisfaction with their physical, social, and home environment. Scores range from 0 to 100, with higher scores representing a better outcome.
Outcome measures
| Measure |
bCBCT+OT-Veterans
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
bCBCT+OT-Partners
n=10 Participants
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) 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 (OT) nasal spray: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
Brief Cognitive-Behavioral Conjoint Therapy: Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
|
|---|---|---|
|
World Health Organization Quality of Life - BREF - Environment
|
64.93 score on a scale
Standard Deviation 18.74
|
72.66 score on a scale
Standard Deviation 14.44
|
Adverse Events
bCBCT-OT-Veteran
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
bCBCT-OT-Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
bCBCT-OT-Veteran
n=10 participants at risk
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).
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.
|
bCBCT-OT-Partner
n=10 participants at risk
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).
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.
|
|---|---|---|
|
Cardiac disorders
pounding heart
|
10.0%
1/10 • Number of events 1 • 11 weeks
|
0.00%
0/10 • 11 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place