ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12620000883910

Ethics application status

Approved

Date submitted

13/07/2020

Date registered

7/09/2020

Date last updated

7/09/2020

Date data sharing statement initially provided

7/09/2020

Date results provided

7/09/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy for Insomnia in Older Adults

Scientific title

Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy on sleep quality and timing in Older Adults suffering from Insomnia.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

insomnia

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A 4-week, group-based treatment program of Cognitive Behaviour Therapy for Insomnia including bedtime restriction therapy, sleep education, and cognitive restructuring.

The intervention comprised 1 x 1 hour consultations per week for 4 weeks with 6-8 people per group and delivered by a psychologist. Activities completed during the intervention sessions were educational sessions and open discussion of topics covered in the educational sessions. Participants were asked to keep a sleep diary and complete questionnaires about their insomnia severity, daytime functioning, and their beliefs about and confidence in their sleep.

The intervention was designed specifically for this study.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Wait list control group.
The intervention was offered to the control group following the 3-month follow up.

Control group

Active

Outcomes

Primary outcome [1]

Subjective sleep quality as assessed by sleep diary reported sleep efficiency

Timepoint [1]

Pre-treatment, Immediately post treatment (primary endpoint), 3-months post treatment

Primary outcome [2]

Insomnia Severity Index

Timepoint [2]

Pre-treatment, Immediately post treatment (primary endpoint), 3-months post treatment

Secondary outcome [1]

Subjective sleep quality as assessed by sleep diary reported wake after sleep onset

Timepoint [1]

Immediately post-treatment

Secondary outcome [2]

Fatigue as assessed by the Flinders Fatigue Scale

Timepoint [2]

Immediately post-treatment

Secondary outcome [3]

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

Timepoint [3]

Immediately post-treatment

Secondary outcome [4]

Daytime sleepiness, assessed by the Epworth Sleepiness Scale

Timepoint [4]

Immediately post-treatment

Secondary outcome [5]

Daytime functioning, assessed by the Daytime Feelings and Functioning Scale

Timepoint [5]

Immediately post-treatment

Secondary outcome [6]

Anxiety about sleep, assessed using the Sleep Anticipatory Anxiety Scale

Timepoint [6]

Immediately post-treatment

Secondary outcome [7]

Confidence in ability to sleep, assessed using the Sleep Self-Efficacy Scale

Timepoint [7]

Immediately post-treatment

Eligibility

Key inclusion criteria

(1) wake after sleep onset of greater than 30 min, at least three nights per w for a reported duration of at least 6 mo, and (2) had impaired daytime functioning such as daytime fatigue or memory problems. All participants were required to remain free of sedatives/hypnotic medication for at least 1 mo prior to and throughout their involvement in the study

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participants with clear clinical symptoms of other sleep disorders or severe medical/psychiatric disorders were excluded. Participants were excluded if they (1) indicated the presence of sleep apnea (AHI >15) or restless legs syndrome, (2) indicated the presence of major depression, anxiety, or serious cognitive impairment, or (3) consumed excessive amounts of caffeine (> 300 mg/day) or alcohol (> two standard drinks/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

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

2/06/2008

Date of last participant enrolment

Anticipated

Actual

10/08/2009

Date of last data collection

Anticipated

Actual

14/02/2011

Sample size

Target

118

Accrual to date

Final

118

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Sturt Rd, Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders University Social and Behavioral Ethics Committee

Ethics committee address [1]

Sturt Rd, Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/02/2008

Ethics approval number [1]

Summary

Brief summary

The current study used a randomized controlled trial to investigate the effects of a brief, group-based CBT-I program  in a large sample of older adults with chronic primary insomnia not currently taking hypnotic/sleep aid medications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Leon Lack

Address

Flinders Health and Medical Research Institute (FHMRI) Sleep Health
College of Medicine & Public Health
Flinders University

FHMRI Sleep Health, Level 2A
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042

Country

Australia

Phone

+61 8 82012391

Fax

[email protected]

Contact person for public queries

Name

Nicole Lovato

Address

Country

Australia

Phone

+61 8 72218307

Fax

[email protected]

Contact person for scientific queries

Name

Nicole Lovato

Address

Country

Australia

Phone

+61 8 72218307

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

There are ethical and logistical considerations that would prevent IPD sharing.

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

Source	Title	Year of Publication	DOI
Embase	Sleep misestimation among older adults suffering from insomnia with short and normal objective sleep duration and the effects of cognitive behavior therapy.	2021	https://dx.doi.org/10.1093/sleep/zsaa250

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically