Sleep-directed Hypnosis As A Complement To Cognitive Processing Therapy (CPT) In Treating Posttraumatic Stress Disorder (PTSD)

NCT ID: NCT00725192

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Cognitive Processing Therapy

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

Clients will receive between 12 sessions of Cognitive Processing Therapy.

2

Hypnosis plus Cognitive Processing Therapy.

Group Type EXPERIMENTAL

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

Clients will receive between 12 sessions of Cognitive Processing Therapy.

Hypnosis

Intervention Type BEHAVIORAL

PArticipants will receive 3 sessions of hypnosis to specifically target sleep impairment.

Interventions

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Cognitive Processing Therapy

Clients will receive between 12 sessions of Cognitive Processing Therapy.

Intervention Type BEHAVIORAL

Hypnosis

PArticipants will receive 3 sessions of hypnosis to specifically target sleep impairment.

Intervention Type BEHAVIORAL

Eligibility 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Center for Trauma Recovery, St Louis

OTHER

Sponsor Role lead

Responsible Party

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University of Missouri- St. Louis

Principal Investigators

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Tara Galovski, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Trauma Recovery, University of Missouri- St. Louis

Locations

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Center for Trauma Recovery

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

Reference Type DERIVED
PMID: 37795783 (View on PubMed)

Alpert E, Carpenter JK, Smith BN, Woolley MG, Raterman C, Farmer CC, Kehle-Forbes SM, Galovski TE. Leveraging observational data to identify in-session patient and therapist predictors of cognitive processing therapy response and completion. J Trauma Stress. 2023 Apr;36(2):397-408. doi: 10.1002/jts.22924. Epub 2023 Mar 29.

Reference Type DERIVED
PMID: 36987703 (View on PubMed)

Other Identifiers

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1R21AT004079-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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