NCT00725192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

3.8 years

First QC Date

July 28, 2008

Last Update Submit

April 6, 2011

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDPosttraumatic Stress DisorderPhysical AssaultPhysical AbuseSexual AssaultSexual AbuseInterpersonal AssaultCognitive Processing TherapySleep ImpairmentInsomniaHypnosis

Outcome Measures

Primary Outcomes (1)

  • Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores

    2 weeks post-treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Cognitive Processing Therapy

Behavioral: Cognitive Processing Therapy

2

EXPERIMENTAL

Hypnosis plus Cognitive Processing Therapy.

Behavioral: Cognitive Processing TherapyBehavioral: Hypnosis

Interventions

Cognitive Processing TherapyBEHAVIORAL

Clients will receive between 12 sessions of Cognitive Processing Therapy.

12
HypnosisBEHAVIORAL

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

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Trauma Recovery

St Louis, Missouri, 63121, United States

Location

Related Publications (2)

  • 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.

    PMID: 37795783DERIVED

  • 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.

    PMID: 36987703DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSleep Initiation and Maintenance Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tara Galovski, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

US(1)