| City: |
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St. Louis |
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State:
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MO |
| Zip Code: |
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63121 |
| Conditions: |
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Posttraumatic Stress Disorder |
| Purpose: |
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Sleep impairment is the most often reported of the 17 PTSD symptoms and is considered one of
the most refractory to treatment. This study proposes the use of sleep-directed hypnotherapy
to address sleep issues as a complementary element to empirically supported Cognitive
Processing Therapy (CPT) in treating PTSD in sexual and physical assault survivors.
Specifically the study aims to: 1) compare the results of sleep-directed hypnosis plus CPT
with CPT only, 2) to assess the relationship between sleep and PTSD symptoms, 3) to examine
relationships between sleep improvement, PTSD symptom improvement, and the therapeutic
elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the
intervention, 4) to assess the relationship between sleep and physical reactivity to
trauma-related cues and to other stimuli.
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| Study summary: |
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Cognitive Processing Therapy (CPT) has demonstrated significant empirical support in
treating victims of sexual assault suffering from Posttraumatic Stress Disorder (PTSD)
throughout its program of research at the University of Missouri - St. Louis. Similarly to
the larger treatment outcome literature, these clinical trials have revealed a portion of
participants whose sleep remains refractory to treatment even after conclusion of a full
course of treatment.
In fact, the specific causes of sleep disturbance in posttraumatic stress disorder (PTSD)
sufferers, the most prominent of which are insomnia and nightmares, have not been
determined. However, sleep impairment is the most often reported of the 17 PTSD symptoms and
is considered one of the most refractory to treatment. It is theorized that PTSD sleep
impairment relates to the hypervigilance inherent in PTSD such that sleep is disrupted by
the perception that vigilance (in response to perceived threat) must be maintained at night.
Sleep impairment seen in PTSD sufferers may then result from increased physiological arousal
associated with chronic hypervigilance. Hypnosis provides deep relaxation which is
hypothesized to decrease overall hyperarousal. Nightmares and trauma cues can further
disrupt sleep through learning and conditioning. PTSD sufferers may learn to associate
nighttime cues with danger and conditioned emotional responses to these cues may disrupt
sleep. Detecting relatively innocuous environmental stimuli (i.e. normal nighttime noises)
while trying to fall asleep and interpreting them as dangerous increases arousal.
Hyperarousal interferes with sleep and has been identified as causal in the development of
non-PTSD insomnia. Beyond decreases in general hyperarousal, an additive benefit of the
hypnotic trance and the use of post-hypnotic suggestion would be the facilitation of new
learning such that bedroom stimuli could become associated with pleasant, restful images.
The use of hypnosis as a complement to CPT, an empirically supported, cognitive-behavioral
intervention developed to treat PTSD, could specifically remediate 1.) sleep onset and
maintenance deficits, 2) the frequency and intensity of parasomnia episodes, and 3.)
cumulative sleep deprivation. Acquisition of the skill of self-hypnosis will provide PTSD
sufferers with a tool to regain normal and restorative sleep patterns. Restoring sleep will
enhance the efficacy of CPT in remediating psychiatric symptoms (PTSD and major depression),
reduce overall physiological reactivity, increase psychosocial functioning, and decrease
somatization.
This study proposes the use of sleep-directed hypnotherapy as a complementary element to the
empirically supported CPT in treating PTSD in sexual and physical assault survivors.
Specifically:
Aim 1: Compare the results of sleep-directed hypnosis + CPT (hypCPT) versus CPT-only (CPT)
within a sample of female sexual/physical assault survivors. It is hypothesized that the
hypCPT group will show significantly greater improvement on overall PTSD severity,
concurrent psychopathology, and overall sleep impairment.
Aim 2: Assess the relationship between sleep and PTSD sxs. Specifically, identify temporal
and directional relationships between elevations in PTSD symptoms and increases in sleep
impairment while accounting for daily life stressors.
Aim 3: Evaluate improvements with respect to the process of therapy. Specifically, examine
relationships between sleep improvement, PTSD symptom improvement, and the therapeutic
elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the
intervention. It is specifically hypothesized that improvements in sleep will be positively
and temporally related to improvements in PTSD symptomatology throughout treatment. Further,
overall decreases in sleep impairment will indicate a temporal, positive relationship to
overall improvements in psychosocial functioning and health-related concerns.
Aim 4: Assess the relationship between sleep and psychophysiological reactivity to
trauma-related cues and to an auditory startle probe. It is hypothesized that impairment in
sleep onset and maintenance, frequency/intensity of parasomnia episodes, and overall sleep
deprivation will be positively related to elevations in psychophysiological reactivity
(heart-rate, skin conductance, and facial EMG) during a scripted-imagery paradigm and an
auditory startle paradigm. It is further hypothesized that decreases in sleep impairment
will be positively related to decreases in physiological reactivity across hypCPT treatment. |
| Criteria: |
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Inclusion Criteria:
- Participants will be at least three months post-crime at the time of their
participation and will have been diagnosed with PTSD. Participants will score at
least a "3" on the CAPS symptom of sleep impairment. This score is indicative of
clinically significant symptomatology on any PTSD symptom. There is no upper limit on
time since the trauma for participation.
Exclusion Criteria:
- Exclusion criteria for participants include psychosis, mental retardation, active
suicidality, parasuicidality, or current addiction to drugs or alcohol. In the case
of apparent illiteracy, we will try to accommodate the individual as much as possible
to maximize success in the program. In addition, participants cannot be in a
currently abusive relationship or being stalked. For marital rape or domestic
violence, the participant must have been out of the relationship for at least three
months. Participants can have received any therapy in the past with the exception of
CPT. They may be receiving concurrent therapy as long as it is not trauma-focused.
Allowing subjects to continue with concurrent therapy offers them the option to
continue with established supports and more closely mimics clinical practice and the
generalizability of the results. Participants will be asked to monitor and adhere to
several behaviors that significantly impact sleep and may introduce error into the
study aims. Inability or unwillingness to comply the the following will constitute
exclusion criteria: Participants will be asked not to increase sleep medications, but
to continue usual practice. This usage will be monitored on a daily basis on the
sleep diaries. Daytime sleeping or naps will be monitored on the daily diaries and
used as an outcome measure as naps are utilized less and less frequently across time
in a number of insomnia treatment studies. Participants will also be asked to keep
alcohol consumption to no more than 14 servings per week with no more than 5 servings
on any given day. We will also ask participants to consume no more than 500 mg of
caffeine on a daily basis and to refrain from caffeine consumption after 6 pm. We
will further ask participants to maintain their bedtime and rise time during the work
week and to not vary these times by more than one hour on days off. Participants will
record bedtime and rise time on their daily diaries. Participants will be asked to
maintain these sleep-related behaviors for the duration of therapy - approximately
8-10 weeks. |
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| Study is available at: |
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Center for Trauma Recovery
St. Louis, MO 63121
United States
Primary Contact:
Leah Blain, BA
Email: leahblain@umsl.edu
Phone: 314-516-6737
Secondary Contact:
Leah Blain, BA
Email: leahblain@umsl.edu
Phone: 314-516-6737 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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