Trial Outcomes & Findings for Efficacy of a Brief Nightmare Treatment for Veterans (NCT NCT01220401)

NCT ID: NCT01220401

Last Updated: 2019-04-30

Results Overview

This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

pre, one week, two months

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	ERRT-M Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ERRT-M Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1

Baseline Characteristics

Efficacy of a Brief Nightmare Treatment for Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERRT-M n=21 Participants Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Age, Customized	56.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: pre, one week, two months

Outcome measures

Outcome measures
Measure	ERRT-M n=18 Participants Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Number of Nights With Nightmares Baseline Nights with Nightmares	2.61 nights/week Standard Deviation 1.79
Number of Nights With Nightmares 1-week Nights with Nightmare	.83 nights/week Standard Deviation 1.20
Number of Nights With Nightmares 2-month Nights with Nightmare	0.97 nights/week Standard Deviation 1.23

PRIMARY outcome

Timeframe: pre, one week, two months

This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 - 4). This study utilized the "FI/I2" rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis. Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD.

Outcome measures

Outcome measures
Measure	ERRT-M n=18 Participants Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Clinician Administered PTSD Scale 1-week TOTAL PTSD	46.44 units on a scale Standard Deviation 27.62
Clinician Administered PTSD Scale Baseline TOTAL PTSD	50.72 units on a scale Standard Deviation 24.60
Clinician Administered PTSD Scale 2-month TOTAL PTSD	43.00 units on a scale Standard Deviation 23.10

PRIMARY outcome

Timeframe: pre, one week, two months

This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).

Outcome measures

Outcome measures
Measure	ERRT-M n=18 Participants Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Past Week Nightmare Frequency Baseline Nightmare Frequency (# in past week)	2.97 nightmares/week Standard Deviation 1.78
Past Week Nightmare Frequency 1 Week Nightmare Frequency (# in past week)	1.17 nightmares/week Standard Deviation 1.48
Past Week Nightmare Frequency 2 Month Nightmare Frequency (# in past week)	1.03 nightmares/week Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 months

This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 - 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.

Outcome measures

Outcome measures
Measure	ERRT-M n=18 Participants Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions. exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
Beck Depression Inventory Baseline Depression	27.61 units on a scale Standard Deviation 11.72
Beck Depression Inventory 1-week Depression	18.94 units on a scale Standard Deviation 8.90
Beck Depression Inventory 2-month Depression	22.11 units on a scale Standard Deviation 11.11

Adverse Events

ERRT-M

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Noelle Balliett

University of Tulsa

Phone: 918-631-3976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place