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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep maintenance insomnia

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Mental Health

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]

Behaviour

Intervention code [2]

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]

Wake after sleep onset assessed using seven day sleep diary and actigraphy

Timepoint [1]

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]

Sleep efficiency assessed using seven day sleep diary and actigraphy

Timepoint [2]

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]

Total sleep time assessed using seven day sleep diary and actigraphy

Timepoint [3]

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]

Number of awakenings assessed from seven day sleep diary

Timepoint [1]

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]

Sleep onset latency assessed using seven day sleep diary

Timepoint [2]

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]

Bedtime assessed using seven day sleep diary

Timepoint [3]

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]

Lights-out time assessed using seven day sleep diary

Timepoint [4]

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]

Sleep onset time assessed using seven day sleep diary

Timepoint [5]

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]

Final wake up time assessed using seven day sleep diary

Timepoint [6]

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]

Time in bed assessed using seven day sleep diary

Timepoint [7]

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]

Insomnia severity assessed using the Insomnia Severity Index

Timepoint [8]

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]

Fatigue assessed using the Flinders Fatigue Scale

Timepoint [9]

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]

Sleepiness assessed using the Epworth Sleepiness Scale

Timepoint [10]

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]

Daily feelings and functioning assessed using the Daytime Feeling and Functioning Scale

Timepoint [11]

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]

Sleep self-efficacy assessed using the Sleep Self-Efficacy Scale

Timepoint [12]

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]

Dysfunctional beliefs and attitudes about sleep assessed using the Dysfunctional Beliefs and Attitudes about sleep Scale

Timepoint [13]

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]

Sleep anticipatory anxiety assessed using the Sleep Anticipatory Anxiety QUestionnaire

Timepoint [14]

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]

Government body

Name [1]

National Health and Medical Research Council Grant

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

GPO Box 2100
Adelaide, SA 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

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

Prof Leon Lack

Address

Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001

Country

Australia

Phone

+61 8 8201 2391

Fax

Email

[email protected]

Contact person for public queries

Name

Leon Lack

Address

Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001

Country

Australia

Phone

+61 8 8201 2391

Fax

Email

[email protected]

Contact person for scientific queries

Name

Nicole Lovato

Address

Flinders University
School of Psychology
GPO Box 2100
Adelaide, S.A. 5001

Country

Australia

Phone

+61 8 8201 2377

Fax

Email

[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.