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- Klinische proef NCT01743339
Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress
A Randomized Controlled Trial of CBT for Insomnia in Patients With PTSD and Depression
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Posttraumatic Stress Disorder (PTSD), which occurs in at least 15-20% of individuals exposed to a traumatic event, is a chronic condition associated with the development of a multitude of negative physical and mental health consequences and the co-occurrence of Major Depressive Disorder (MDD). Sleep disturbances, and especially nightmares and insomnia, are quite common in patients with PTSD, but the standard treatments for PTSD do not directly focus on sleep problems. Perhaps as a result, sleep disturbances are one of the most common residual symptoms following both PTSD treatments and depression treatments. Importantly, insomnia, depression and PTSD are each characterized by similar biological dysregulation, including alterations in important aspects of sleep (rapid eye movement sleep and slow wave sleep) as well as processes linked to health and disease (stress system responses and inflammatory processes).
Directly treating sleep in the context of PTSD and MDD is feasible and can lead to robust improvements in sleep, though whether improving sleep can enhance PTSD and MDD outcomes remains to be established. This study will enroll and randomize 150 participants with PTSD, MDD and insomnia. Following baseline assessments (T1) participants will be randomized to receive cognitive-behavioral therapy for insomnia(CBTi), a well-supported and highly effective insomnia treatment, or to a monitor only control condition. Following this first intervention period all participants will receive cognitive processing therapy, a trauma focused therapy with known effects on PTSD and depression. The study will test whether and how CBTi may(1) achieve improvements in PTSD and MDD symptom severity and (2) lead to enhanced response to subsequent treatment with cognitive processing therapy.
Intervening with CBTi prior to a PTSD-specific treatment and measuring biomarkers longitudinally, will allow for the testing of specific effects of sleep improvement on PTSD, depressive symptoms, objective aspects sleep and stress and inflammatory markers, thereby advancing basic understanding of biobehavioral mechanisms in PTSD and depression. Importantly, the proposed approach utilizes a treatment sequence that may appeal to trauma survivors with post-traumatic event symptoms who may be resistant to or unprepared to fully engage in standard PTSD treatments. Confirmation of the study hypotheses could support immediate translation of the findings to clinical practice.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- must be English-speaking
- age 18-64 years old
- with exposure to trauma from interpersonal violence in the past year
- meet diagnostic criteria for full or subthreshold PTSD
- meet diagnostic criteria for MDD
- meet criteria for Insomnia Disorder
Exclusion Criteria:
- untreated sleep disorders other than insomnia or nightmares
- dementia or cognitive impairment
- history of schizophrenia or bipolar I disorder
- current suicidality
- health conditions with immunological components or taking immunosuppressive therapies
- active alcohol dependence
- medication use including antipsychotics, opiate analgesics, and sleep medications
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Control
Control (brief check-in calls) and Cognitive Processing Therapy (12 individual weekly sessions)
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Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions.
Andere namen:
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Experimenteel: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia (4 individual therapy sessions over 5 weeks) and Cognitive Processing Therapy (12 individual weekly sessions)
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Cognitive Behavioral Therapy for Insomnia(4 individual therapy sessions over 5 weeks) will consist of a standard, structured, multi-component CBT intervention (sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention) Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PTSD (intensity and frequency for each symptom, and remission)
Tijdsspanne: 20 weeks
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The Clinician Administered PTSD Scale (CAPS)will be used as our primary PTSD outcome measure.
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20 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Insomnia severity
Tijdsspanne: 20 weeks
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The Insomnia Severity Index will measure insomnia severity.
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20 weeks
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Depression
Tijdsspanne: 20 weeks
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The Hamilton Rating Scale for Depression-17 (HRSD-17)will be used as our primary measure of depressive symptoms.
The MINI will be used to identify MDD remission status.
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20 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sleep
Tijdsspanne: 7 weeks.
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The primary objective sleep outcomes will be rapid eye movement (REM) arousals and Slow Wave Activity.
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7 weeks.
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Salivary Cortisol
Tijdsspanne: 7 weeks
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Salivary cortisol will be measured in the Psychoneuroimmunology (PNI) Lab using a cortisol HS enzyme immunoassay kit.
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7 weeks
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Inflammatory cytokine levels (IL-6)
Tijdsspanne: 7 weeks
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Inflammatory cytokine levels (IL-6) will be measured in the PNI Lab using Quantikine high sensitivity (HS) ELISA kits.
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7 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Wilfred R. Pigeon, Ph.D., University of Rochester
- Hoofdonderzoeker: Kathi L. Heffner, Ph.D., University of Rochester
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 44033
- R01NR013909 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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