Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001312730
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
25/11/2013
Date last updated
25/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of a brief cognitive-behaviour therapy treatment program for the treatment of sleep maintenance insomnia in older adults.
Scientific title
The evaluation of a brief cognitive-behaviour therapy treatment program for the treatment of sleep maintenance insomnia in older adults.
Secondary ID [1] 281871 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep maintenance insomnia 288253 0
Condition category
Condition code
Other 288606 288606 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 290977 290977 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised control trial was used to assess a brief treatment program of cognitive-behaviour therapy. CBT-I comprised of 1 x 1 hour session per week for 4 weeks. CBT-I was delivered by trainee psychologists to small groups of 4-6 participants.
Intervention code [1] 286433 0
Behaviour
Intervention code [2] 288348 0
Treatment: Other
Comparator / control treatment
Waitlist control group. The waitlist control group was offered the intervention after the 3-month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 288756 0
Wake after sleep onset assessed using seven day sleep diary and actigraphy
Timepoint [1] 288756 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Primary outcome [2] 290966 0
Sleep efficiency assessed using seven day sleep diary and actigraphy
Timepoint [2] 290966 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Primary outcome [3] 290967 0
Total sleep time assessed using seven day sleep diary and actigraphy
Timepoint [3] 290967 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [1] 300909 0
Number of awakenings assessed from seven day sleep diary
Timepoint [1] 300909 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [2] 305684 0
Sleep onset latency assessed using seven day sleep diary
Timepoint [2] 305684 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [3] 305685 0
Bedtime assessed using seven day sleep diary
Timepoint [3] 305685 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [4] 305686 0
Lights-out time assessed using seven day sleep diary
Timepoint [4] 305686 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [5] 305687 0
Sleep onset time assessed using seven day sleep diary
Timepoint [5] 305687 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [6] 305688 0
Final wake up time assessed using seven day sleep diary
Timepoint [6] 305688 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [7] 305689 0
Time in bed assessed using seven day sleep diary
Timepoint [7] 305689 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [8] 305690 0
Insomnia severity assessed using the Insomnia Severity Index
Timepoint [8] 305690 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [9] 305691 0
Fatigue assessed using the Flinders Fatigue Scale
Timepoint [9] 305691 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [10] 305692 0
Sleepiness assessed using the Epworth Sleepiness Scale
Timepoint [10] 305692 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [11] 305693 0
Daily feelings and functioning assessed using the Daytime Feeling and Functioning Scale
Timepoint [11] 305693 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [12] 305694 0
Sleep self-efficacy assessed using the Sleep Self-Efficacy Scale
Timepoint [12] 305694 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [13] 305695 0
Dysfunctional beliefs and attitudes about sleep assessed using the Dysfunctional Beliefs and Attitudes about sleep Scale
Timepoint [13] 305695 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up
Secondary outcome [14] 305696 0
Sleep anticipatory anxiety assessed using the Sleep Anticipatory Anxiety QUestionnaire
Timepoint [14] 305696 0
Immediately following treatment (commencing in week 5, the week immediately following the conclusion of the 4-week treatment program).

3-month follow up

Eligibility
Key inclusion criteria
Participants were included in this study if they experienced (a) wake after sleep onset of greater than 30-minutes, at least three nights per week for a reported duration of at least 6-months, and (b) impaired daytime functioning such as daytime fatigue or memory problems. All participants were required to remain free of sedative/hypnotic medication for at least one month prior to and throughout their involvement in the study.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with clear clinical symptoms of other sleep disorders or severe medical/psychiatric disorders were excluded. Participants were excluded if they (a) indicated the presence of sleep apnoea (AHI>15) or restless legs syndrome, (b) indicated the presence of major depression, anxiety or serious cognitive impairment, or (c) consumed excessive amounts of caffeine (>300mg per day) or alcohol (> two standard drinks per day).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2008
Actual
9/06/2008
Date of last participant enrolment
Anticipated
Actual
18/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286654 0
Government body
Name [1] 286654 0
National Health and Medical Research Council Grant
Country [1] 286654 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 285433 0
None
Name [1] 285433 0
Address [1] 285433 0
Country [1] 285433 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective: To evaluate the efficacy of a brief four-week group-administered treatment program of cognitive-behavior therapy (CBT-I) for older adults with sleep maintenance insomnia.

Design: Randomized controlled trial of CBT-I compared to waitlist control with comparisons at pre-treatment, post-treatment, and 3-month follow up.

Setting: Flinders University Sleep and Circadian Rhythm Research Laboratory, Adelaide, South Australia.

Participants: One-hundred and eighteen (mean age = 63.76 years, SD = 6.45, Male = 55) adults with sleep maintenance insomnia.

Interventions: A four-week, group-based treatment program of CBT-I including bedtime restriction therapy, sleep education and cognitive restructuring.

Measurements: Seven-day sleep diaries, actigraphy, and several self-report measures to assess perceived insomnia severity, daytime functioning, confidence in and beliefs about sleep.

Results: The brief group-administered CBT-I program produced robust and durable improvements in the timing and quality of sleep, perceived insomnia severity, daytime functioning, and participants’ confidence in and beliefs about sleep.

Conclusions: The treatment program used in the current study has demonstrated impressive potential for a brief, inexpensive, and effective treatment of sleep maintenance insomnia in the older adult population.
Trial website
Trial related presentations / publications
Lovato, N., Lack, L., Wright, H. & Kennaway, D.J. (in press) The evaluation of a brief treatment program of cognitive-behaviour therapy for insomnia in older adults. Sleep

Lovato N., Lack, L., Wright, H., & Kennaway, D.J. (2013). Predictors of improvement in subjective sleep quality reported by older adults following group-based Cognitive-Behaviour Therapy for sleep maintenance and early morning awakening insomnia. Sleep Medicine, 14, 888-893

Lovato, N., Lack, L., Wright, H., Kemps, E., Cant, M., & Humphries, J. (2013). A preliminary assessment of the reliability and validity of a computerized working memory task. Perceptual and Motor Skills,116(2), 368-381

Lovato, N., Lack, L., Wright, H., Cant, M., & Humphries, J. (2012). Working memory performance of older adults with insomnia. Journal of Sleep Research, 22, 251-257.


N, Lovato., L, Lack., Wright, H., Kennaway, D.J., (2013). A randomized controlled trial of brief, group-administered CBT for the treatment of insomnia in older adults. 27th Anniversary Meeting of the Associated Professional Sleep Societies: Baltimore, Maryland, United States of America.

N, Lovato., L, Lack., Wright, H., Kennaway, D.J., (2013). Predictors of improvement in subjective sleep quality reported by older adults with sleep maintenance insomnia following group-based CBT-I. 27th Anniversary Meeting of the Associated Professional Sleep Societies: Baltimore, Maryland, United States of America.


N, Lovato., L, Lack., & H, Wright. (2012). A randomized controlled trial of a combined treatment of cognitive behaviour therapy and evening bright light therapy for insomnia in older adults. Paper presented at 24th Annual Scientific Meeting of the Australasian Sleep Association, Darwin, October 10-13.

N, Lovato., L, Lack., & H, Wright. (2012). Predictors of improvement in subjective sleep quality reported by older adults with sleep maintenance insomnia following group-based CBT-I. Paper presented at 24th Annual Scientific Meeting of the Australasian Sleep Association, Darwin, October 10-13.


N, Lovato., L, Lack., & H Wright (2011). A randomized controlled trial of a combined treatment of cognitive behaviour therapy and evening bright light therapy for insomnia in older adults. 25th Anniversary Meeting of the Associated Professional Sleep Societies: Minneapolis, United States of America.

N, Lovato., L, Lack., H, Wright., M, Cant., & J, Humphries (2011). Do older adults with insomnia have impaired working memory performance? 25th Anniversary Meeting of the Associated Professional Sleep Societies: Minneapolis, United States of America.


N, Lovato., M, Cant., L. Lack., & H, Wright. (2010). The working memory performance of older adults with insomnia. 22nd Annual Scientific Meeting of Australasian Sleep Association and Australasian Sleep Technologists Association: Christchurch, New Zealand.

M. Cant., L. Lack., H. Wright., & N. Lovato. (2010). Is working memory performance impaired in older adults with insomnia. 20th Congress of the European Sleep Research Society: Lisbon, Portugal.

N, Lovato., M, Cant., L, Lack., & H, Wright. (2010). Working memory performance of older adults with insomnia. 1st Annual Scientific Meeting of the Adelaide Sleep Retreat: Adelaide, Australia.

N, Lovato., L, Lack., & H, Wright. (2010). The evaluation of Cognitive Behaviour Therapy and Evening Bright Light Therapy for insomnia in older adults. 1st Annual Meeting of the Adelaide Sleep Retreat: Adelaide, Australia.
Public notes

Contacts
Principal investigator
Name 37494 0
Prof Leon Lack
Address 37494 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001
Country 37494 0
Australia
Phone 37494 0
+61 8 8201 2391
Fax 37494 0
Email 37494 0
[email protected]
Contact person for public queries
Name 37495 0
Leon Lack
Address 37495 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001
Country 37495 0
Australia
Phone 37495 0
+61 8 8201 2391
Fax 37495 0
Email 37495 0
[email protected]
Contact person for scientific queries
Name 37496 0
Nicole Lovato
Address 37496 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001
Country 37496 0
Australia
Phone 37496 0
+61 8 8201 2377
Fax 37496 0
Email 37496 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.