Brief Behavioral Insomnia Treatment Study (BBTI)
28. januar 2020 opdateret af: VA Office of Research and Development
Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder.
The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome.
Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
93
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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San Francisco, California, Forenede Stater, 94121
- San Francisco VA Medical Center, San Francisco, CA
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Veterans between the ages of 18-75 years.
- Meet DSM-5 Criteria for Insomnia Disorder.
- Able attend in-person appointments at the San Francisco VA Medical Center
The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
- Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.
- However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
- The investigators will not exclude individuals with TBI.
- The investigators will not exclude individuals with chronic pain.
- The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.
Exclusion Criteria:
- Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
- Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
- Veterans with suicidal or homicidal ideation.
- Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
- Veterans who work night or rotating shifts.
- Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
|
Aktiv komparator: Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
Tidsramme: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
|
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
|
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
|
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Work and Social Adjustment Scale (WSAS)
Tidsramme: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
|
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
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Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Insomnia Severity (ISI)
Tidsramme: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
|
The ISI is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
|
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
|
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Insomnia Severity (ISI)
Tidsramme: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
|
Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
|
Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
- Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. januar 2016
Primær færdiggørelse (Faktiske)
31. marts 2019
Studieafslutning (Faktiske)
30. juni 2019
Datoer for studieregistrering
Først indsendt
2. oktober 2015
Først indsendt, der opfyldte QC-kriterier
6. oktober 2015
Først opslået (Skøn)
8. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D1539-I
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