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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Center for Trauma Recovery, St Louis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Center for Trauma Recovery, St Louis
ClinicalTrials.gov Identifier:
NCT00725192
First received: July 28, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Behavioral: Cognitive Processing Therapy
Behavioral: Hypnosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep-directed Hypnosis As A Complement To CPT In Treating PTSD

Resource links provided by NLM:


Further study details as provided by Center for Trauma Recovery, St Louis:

Primary Outcome Measures:
  • Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores [ Time Frame: 2 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725192

Locations
United States, Missouri
Center for Trauma Recovery
St. Louis, Missouri, United States, 63121
Sponsors and Collaborators
Center for Trauma Recovery, St Louis
Investigators
Principal Investigator: Tara Galovski, PhD Center for Trauma Recovery, University of Missouri- St. Louis
  More Information

No publications provided

Responsible Party: Tara Galovski, University of Missouri- St. Louis
ClinicalTrials.gov Identifier: NCT00725192     History of Changes
Other Study ID Numbers: 1R21AT004079-01A1
Study First Received: July 28, 2008
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014