NCT02076165

Brief Summary

Women Veterans have high rates of insomnia. Prior research and our preliminary findings show that insomnia impacts the health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. This study compared two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. A novel treatment, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I) was compared to standard treatment, Cognitive Behavioral Therapy for Insomnia (CBT-I). The results showed that ABC-I was non-inferior to CBT-I and adherence to the treatments was similar in both groups. These results improve the repertoire of available behavioral treatments for insomnia within VA by showing that a new treatment, called ABC-I, works as well as standard CBT-I.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

3.5 years

First QC Date

February 27, 2014

Results QC Date

February 27, 2019

Last Update Submit

May 31, 2019

Conditions

Insomnia

Keywords

insomniawomen

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Completing 5 Behavioral Treatment Sessions

    Number of participants who attended and completed all 5 behavioral treatment sessions.

    End of the 5-week behavioral treatment period

  • Adherence With Bedtime Recommendations

    Minutes deviation from recommended bedtime recommendations during final week of intervention period.

    Final 7 nights of the 5-week intervention period

  • Adherence to Rise Time Recommendations

    Minutes deviation from recommended rise time during the final week of the intervention period

    Final 7-nights of the 5-week intervention period

  • Non-adherence to Nighttime Stimulus Control

    Average proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.

    Final 7-nights of the 5-week intervention period

Secondary Outcomes (6)

  • Sleep Efficiency From Sleep Diary at Post-Treatment

    1 week after the end of the 5-week intervention period

  • Sleep Efficiency From Sleep Diary at 3-month Follow-up

    3-months after randomization

  • Sleep Efficiency From Actigraphy at Post-Treatment

    1 week after the end of the 5-week intervention period

  • Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up

    3-months after randomization

  • Change From Baseline to Post-Treatment in Insomnia Severity Index Score

    Baseline and 1 week after the end of the 5-week intervention period

  • +1 more secondary outcomes

Study Arms (2)

ABC-I

EXPERIMENTAL

Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.

Behavioral: Acceptance and the Behavioral Changes to Treat Insomnia

CBT-I

ACTIVE COMPARATOR

Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.

Behavioral: Cognitive behavioral therapy for insomnia

Interventions

Acceptance and the Behavioral Changes to Treat InsomniaBEHAVIORAL

Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.

Also known as: ABC-I
ABC-I
Cognitive behavioral therapy for insomniaBEHAVIORAL

Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Also known as: CBT-I
CBT-I

Eligibility Criteria

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

You may qualify if:

  • Female Veteran
  • Community-dwelling
  • Age 18 years and older
  • Received care from VA Greater Los Angeles Healthcare System in the past six months
  • Responses to postal survey indicate symptoms of insomnia
  • Did not check "opt-out" box for further contact on postal survey
  • Live within 50 mile radius of Sepulveda VA Ambulatory Care Center

You may not qualify if:

  • Unstable housing
  • No transportation to the medical center
  • Current pregnancy
  • Significant health or emotional problems, or use of drugs or alcohol
  • Untreated sleep apnea
  • Restless legs syndrome that accounts for the sleep disturbances reported
  • Circadian rhythm sleep disorder that accounts for the sleep disturbances reported
  • Active substance users or in recovery with less than 90 days of sobriety
  • Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
  • Remission of insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Publications (7)

  • Fung CH, Martin JL, Hays RD, Rodriguez JC, Igodan U, Jouldjian S, Dzierzewski JM, Kramer BJ, Josephson K, Alessi C. Development of the Usability of Sleep Apnea Equipment-Positive Airway Pressure (USE-PAP) questionnaire. Sleep Med. 2015 May;16(5):645-51. doi: 10.1016/j.sleep.2015.01.019. Epub 2015 Feb 12.

    PMID: 25890783RESULT

  • Dzierzewski JM, Mitchell M, Rodriguez JC, Fung CH, Jouldjian S, Alessi CA, Martin JL. Patterns and predictors of sleep quality before, during, and after hospitalization in older adults. J Clin Sleep Med. 2015 Jan 15;11(1):45-51. doi: 10.5664/jcsm.4362.

    PMID: 25325580RESULT

  • Culver NC, Song Y, Kate McGowan S, Fung CH, Mitchell MN, Rodriguez JC, Dzierzewski JM, Josephson KR, Jouldjian S, Washington DL, Yano EM, Schweizer CA, Alessi CA, Martin JL. Acceptability of Medication and Nonmedication Treatment for Insomnia Among Female Veterans: Effects of Age, Insomnia Severity, and Psychiatric Symptoms. Clin Ther. 2016 Nov;38(11):2373-2385. doi: 10.1016/j.clinthera.2016.09.019. Epub 2016 Oct 27.

    PMID: 28314434RESULT

  • Song Y, Washington DL, Yano EM, McCurry SM, Fung CH, Dzierzewski JM, Rodriguez JC, Jouldjian S, Mitchell MN, Alessi CA, Martin JL. Caregiving-Related Sleep Problems and Their Relationship to Mental Health and Daytime Function in Female Veterans. Behav Sleep Med. 2018 Jul-Aug;16(4):371-379. doi: 10.1080/15402002.2016.1228640. Epub 2016 Oct 3.

    PMID: 27690634RESULT

  • Saldana KS, Carlson GC, Revolorio K, Kelly MR, Josephson KR, Mitchell MN, Culver N, Kay M, McGowan SK, Song Y, Deleeuw C, Martin JL. Values Expressed by Women Veterans Receiving Treatment for Chronic Insomnia Disorder. Behav Sleep Med. 2024 May-Jun;22(3):340-352. doi: 10.1080/15402002.2023.2260517. Epub 2023 Sep 25.

    PMID: 37749876DERIVED

  • Martin JL, Carlson GC, Kelly MR, Song Y, Mitchell MN, Josephson KR, McGowan SK, Culver NC, Kay MA, Erickson AJ, Saldana KS, May KJ, Fiorentino L, Alessi CA, Washington DL, Yano EM. Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans. J Consult Clin Psychol. 2023 Nov;91(11):626-639. doi: 10.1037/ccp0000836. Epub 2023 Aug 3.

    PMID: 37535521DERIVED

  • Carlson GC, Kelly MR, Grinberg AM, Mitchell M, McGowan SK, Culver NC, Kay M, Alessi CA, Washington DL, Yano EM, Martin JL. Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms. Behav Sleep Med. 2021 Sep-Oct;19(5):672-688. doi: 10.1080/15402002.2020.1846537. Epub 2020 Nov 30.

    PMID: 33251855DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Jennifer Martin
Organization
VA Greater Los Angeles Healthcare System
Jennifer.Martin@va.gov
818 891-7711

Study Officials

  • Jennifer Martin, PhD

    VA Greater Los Angeles Healthcare System, Sepulveda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

September 1, 2014

Primary Completion

February 28, 2018

Study Completion

August 31, 2018

Last Updated

June 11, 2019

Results First Posted

May 31, 2019

Record last verified: 2019-05

Locations

US(1)