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

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ClinicalTrials.gov Identifier: NCT00725192
Recruitment Status : Unknown
Verified April 2011 by Center for Trauma Recovery, St Louis.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2008
Last Update Posted : April 7, 2011
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Behavioral: Cognitive Processing Therapy Behavioral: Hypnosis

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep-directed Hypnosis As A Complement To CPT In Treating PTSD
Study Start Date : July 2008
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Cognitive Processing Therapy
Behavioral: Cognitive Processing Therapy
Clients will receive between 12 sessions of Cognitive Processing Therapy.
Experimental: 2
Hypnosis plus Cognitive Processing Therapy.
Behavioral: Cognitive Processing Therapy
Clients will receive between 12 sessions of Cognitive Processing Therapy.
Behavioral: Hypnosis
PArticipants will receive 3 sessions of hypnosis to specifically target sleep impairment.

Outcome Measures

Primary Outcome Measures :
  1. Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores [ Time Frame: 2 weeks post-treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725192

United States, Missouri
Center for Trauma Recovery
St. Louis, Missouri, United States, 63121
Sponsors and Collaborators
Center for Trauma Recovery, St Louis
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Tara Galovski, PhD Center for Trauma Recovery, University of Missouri- St. Louis
More Information

Responsible Party: Tara Galovski, University of Missouri- St. Louis
ClinicalTrials.gov Identifier: NCT00725192     History of Changes
Other Study ID Numbers: 1R21AT004079-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by Center for Trauma Recovery, St Louis:
Posttraumatic Stress Disorder
Physical Assault
Physical Abuse
Sexual Assault
Sexual Abuse
Interpersonal Assault
Cognitive Processing Therapy
Sleep Impairment

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs