Trial Outcomes & Findings for Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance (NCT NCT00108628)

NCT ID: NCT00108628

Last Updated: 2015-02-18

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

Baseline and 1, 3, and 6 months post-treatment

Results posted on

2015-02-18

Participant Flow

Ten participants dropped out prior to randomization.

Participant milestones

Participant milestones
Measure
Imagery Rehearsal Therapy
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Overall Study
STARTED
61
63
Overall Study
Received One or More Sessions
53
58
Overall Study
Completed Treatment
42
57
Overall Study
COMPLETED
41
53
Overall Study
NOT COMPLETED
20
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Imagery Rehearsal Therapy
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Overall Study
Withdrawal by Subject
17
9
Overall Study
Lack of Efficacy
2
1
Overall Study
Death
1
0

Baseline Characteristics

Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Total
n=124 Participants
Total of all reporting groups
Age, Continuous
59.79 years
STANDARD_DEVIATION 3.18 • n=5 Participants
59.06 years
STANDARD_DEVIATION 3.86 • n=7 Participants
59.42 years
STANDARD_DEVIATION 3.55 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
61 Participants
n=5 Participants
63 Participants
n=7 Participants
124 Participants
n=5 Participants
Region of Enrollment
United States
61 participants
n=5 Participants
63 participants
n=7 Participants
124 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Weekly Number of Nightmares
Baseline
3.95 weekly nightmares
Standard Deviation 2.37
3.88 weekly nightmares
Standard Deviation 3.95
Weekly Number of Nightmares
1 month
3.28 weekly nightmares
Standard Deviation 2.47
3.47 weekly nightmares
Standard Deviation 2.72
Weekly Number of Nightmares
3 months
3.61 weekly nightmares
Standard Deviation 2.63
3.09 weekly nightmares
Standard Deviation 2.08
Weekly Number of Nightmares
6 months
3.20 weekly nightmares
Standard Deviation 2.14
3.04 weekly nightmares
Standard Deviation 1.89

PRIMARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Weekly Nights With a Nightmare
Baseline
2.96 nights/week
Standard Deviation 1.39
3.00 nights/week
Standard Deviation 1.43
Weekly Nights With a Nightmare
1 month
2.67 nights/week
Standard Deviation 1.64
2.78 nights/week
Standard Deviation 1.54
Weekly Nights With a Nightmare
3 months
3.10 nights/week
Standard Deviation 1.70
2.55 nights/week
Standard Deviation 1.41
Weekly Nights With a Nightmare
6 months
2.98 nights/week
Standard Deviation 1.69
2.68 nights/week
Standard Deviation 1.42

PRIMARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Pittsburgh Sleep Quality Index
Baseline
13.40 units on a scale
Standard Deviation 3.00
12.85 units on a scale
Standard Deviation 3.32
Pittsburgh Sleep Quality Index
1 month
12.09 units on a scale
Standard Deviation 4.26
11.82 units on a scale
Standard Deviation 3.79
Pittsburgh Sleep Quality Index
3 months
12.57 units on a scale
Standard Deviation 3.83
11.70 units on a scale
Standard Deviation 3.90
Pittsburgh Sleep Quality Index
6 months
12.06 units on a scale
Standard Deviation 4.09
12.00 units on a scale
Standard Deviation 4.51

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Pittsburgh Sleep Quality Index - Addendum
Baseline
17.51 units on a scale
Standard Deviation 4.96
17.01 units on a scale
Standard Deviation 3.76
Pittsburgh Sleep Quality Index - Addendum
1 month post-treatment
16.71 units on a scale
Standard Deviation 5.18
16.29 units on a scale
Standard Deviation 3.91
Pittsburgh Sleep Quality Index - Addendum
3 months post-treatment
16.58 units on a scale
Standard Deviation 5.56
16.36 units on a scale
Standard Deviation 4.16
Pittsburgh Sleep Quality Index - Addendum
6 months post-treatment
17.35 units on a scale
Standard Deviation 5.13
17.26 units on a scale
Standard Deviation 4.56

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Nightmare Effects Survey
Baseline
26.39 units on a scale
Standard Deviation 9.00
24.11 units on a scale
Standard Deviation 9.99
Nightmare Effects Survey
1 month post-treatment
24.12 units on a scale
Standard Deviation 10.43
24.66 units on a scale
Standard Deviation 9.18
Nightmare Effects Survey
3 months post-treatment
25.28 units on a scale
Standard Deviation 10.06
24.02 units on a scale
Standard Deviation 10.22
Nightmare Effects Survey
6 months post-treatment
25.88 units on a scale
Standard Deviation 9.75
24.98 units on a scale
Standard Deviation 10.14

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
PTSD Military Checklist
6 months post-treatment
59.05 units on a scale
Standard Deviation 11.87
59.64 units on a scale
Standard Deviation 12.30
PTSD Military Checklist
Baseline
62.73 units on a scale
Standard Deviation 10.18
65.06 units on a scale
Standard Deviation 9.48
PTSD Military Checklist
1 month post-treatment
58.83 units on a scale
Standard Deviation 13.56
60.96 units on a scale
Standard Deviation 11.43
PTSD Military Checklist
3 months post-treatment
60.13 units on a scale
Standard Deviation 12.16
61.13 units on a scale
Standard Deviation 12.00

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Beck Depression Inventory
Baseline
26.85 units on a scale
Standard Deviation 11.82
23.51 units on a scale
Standard Deviation 11.92
Beck Depression Inventory
1 month post-treatment
24.16 units on a scale
Standard Deviation 13.35
22.31 units on a scale
Standard Deviation 12.76
Beck Depression Inventory
3 months post-treatment
24.80 units on a scale
Standard Deviation 13.14
23.76 units on a scale
Standard Deviation 12.76
Beck Depression Inventory
6 months post-treatment
25.02 units on a scale
Standard Deviation 13.30
23.37 units on a scale
Standard Deviation 12.34

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
SF-36 Physical Component
Baseline
37.17 units on a scale
Standard Deviation 9.21
38.53 units on a scale
Standard Deviation 9.64
SF-36 Physical Component
1 month post-treatment
39.48 units on a scale
Standard Deviation 10.19
36.84 units on a scale
Standard Deviation 10.34
SF-36 Physical Component
3 months post-treatment
37.72 units on a scale
Standard Deviation 9.57
35.96 units on a scale
Standard Deviation 11.97
SF-36 Physical Component
6 months post-treatment
35.80 units on a scale
Standard Deviation 9.64
37.21 units on a scale
Standard Deviation 11.23

SECONDARY outcome

Timeframe: Baseline and 1, 3, and 6 months post-treatment

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
SF-36 Mental Component
Baseline
29.69 units on a scale
Standard Deviation 9.08
34.52 units on a scale
Standard Deviation 12.06
SF-36 Mental Component
1 month post-treatment
32.33 units on a scale
Standard Deviation 10.63
32.84 units on a scale
Standard Deviation 9.75
SF-36 Mental Component
3 months post-treatment
30.98 units on a scale
Standard Deviation 9.33
34.00 units on a scale
Standard Deviation 10.35
SF-36 Mental Component
6 months post-treatment
32.15 units on a scale
Standard Deviation 8.99
34.78 units on a scale
Standard Deviation 10.87

SECONDARY outcome

Timeframe: Baseline and 1 month post-treatment

Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.

Outcome measures

Outcome measures
Measure
Imagery Rehearsal Therapy
n=61 Participants
Imagery Rehearsal Therapy Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare Management
n=63 Participants
Sleep and Nightmare Management Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Clinician-Administered PTSD Scale (CAPS)
Baseline
81.34 units on a scale
Standard Deviation 14.00
79.48 units on a scale
Standard Deviation 15.27
Clinician-Administered PTSD Scale (CAPS)
1 month post-treatment
74.04 units on a scale
Standard Deviation 20.36
74.85 units on a scale
Standard Deviation 19.52

Adverse Events

Imagery Rehearsal Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sleep and Nightmare Management

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. Richard Ross

Philadelphia VA Medical Center

Phone: (215) 823-4046

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place