ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000092695

Ethics application status

Approved

Date submitted

22/12/2022

Date registered

27/01/2023

Date last updated

27/01/2023

Date data sharing statement initially provided

27/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Multiple Baseline Clinical Trial Investigating the Efficacy of an Acceptance and Commitment Therapy (ACT)-Based Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) on Sleep, Mental Health, and Quality of Life

Scientific title

Multiple Baseline Clinical Trial Investigating the Efficacy of an ACT-Based Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) on Sleep, Mental Health, and Quality of Life

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1284-4388

Trial acronym

Linked study record

Health condition

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

insomnia

anxiety

depression

poor quality of life

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Mental Health

Depression

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Eligible participants will be randomised into one of three baseline lengths (2, 3 or 4 weeks), delivered non-concurrently. After completion of baseline monitoring, participants will begin the SLEAPI intervention, delivered in-person at the La Trobe University Psychology Clinic.

SLEAPI aims to target processes associated with hyperarousal and sleep disturbance: inflexibility, cognitive fusion, and experiential avoidance. Like other ACT approaches for insomnia there is the encouragement for participants to shift their efforts to values-based living, rather than continuing to focus on trying to fix sleep problems through over-control and rigid routines. This is done through encouraging participants to explore experientially whether the ways they cope with insomnia are leading to life becoming smaller, and the sleep problems bigger and more central to their lives.

Individualized SLEAPI consists of 8 x 50-minute sessions delivered over 8 weeks. Prior to all sessions, participants will have completed online sleep diaries and questionnaires. The clinicians will have calculated everyone’s questionnaire and sleep diary values for discussion and problem-solving. SLEAPI will be delivered by provisional psychologists under the supervision of a clinical psychologist.

Participants in SLEAPI will be given a Workbook that will be adapted from the original group intervention (available from Dr Eric Morris, La Trobe University) and developed for this trial. The workbook includes information presented in session, worksheets, and exercises, to refer in in session and at home.

Provisional Psychologists will follow a SLEAPI manual adapted from the original group intervention (available from Dr Eric Morris, La Trobe University) and developed for this trial. Each SLEAPI session has an aim, where the provisional psychologist will describe a concept or strategy, and use exercises or worksheets to demonstrate the concept or strategy for the participant. Participants will be asked to complete homework exercises between sessions to reinforce strategies learnt during the session and record progress.

The ACT Fidelity Measure (ACT-FM) (O'Neill et al., 2019) will be utilised at the end of every session to ensure the intervention is being delivered appropriately and consistently among clinicians. Upon completion of the intervention, participants will then begin a follow-up monitoring period, ranging from 2-4 weeks depending on the length of their baseline.

Intervention code [1]

Behaviour

Comparator / control treatment

A non-concurrent multiple baseline design will be used to track the effects of the intervention. The use of a multiple baseline design allows participants in the longer baseline phases to act as controls/comparators for those in the intervention phase. In this design all participants will receive the same intervention.

Control group

Active

Outcomes

Primary outcome [1]

Total Insomnia Severity Index score

Timepoint [1]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring)[primary timepoint] and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [1]

Sleep onset latency measured by the Consensus Sleep Diary

Timepoint [1]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [2]

Wake after sleep onset measured by the Consensus Sleep Diary

Timepoint [2]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [3]

Sleep Efficiency measured by the Consensus Sleep Diary

Timepoint [3]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [4]

Total Sleep time measured by the Consensus Sleep Diary

Timepoint [4]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [5]

Perceived restfulness after sleep measured by the Consensus Sleep Diary

Timepoint [5]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [6]

Overall sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [6]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [7]

Sleep onset latency measured by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [7]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [8]

Wake after sleep onset measured by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [8]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [9]

Sleep efficiency measured by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [9]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [10]

Total sleep time measured by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [10]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [11]

Sleep onset latency measured by actigraphy

Timepoint [11]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [12]

Wake after sleep onset measured by actigraphy

Timepoint [12]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [13]

Sleep efficiency measured by actigraphy

Timepoint [13]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [14]

Total sleep time measured by actigraphy

Timepoint [14]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [15]

Change in Generalised Anxiety Disorder 7-item scale (GAD-7) scores

Timepoint [15]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [16]

Change in anxiety question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [16]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [17]

Change in depressive symptoms assessed using Patient Health Questionnaire (PHQ-9) scores

Timepoint [17]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [18]

Change in depression question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [18]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [19]

Change in pre-sleep somatic arousal subscale of the Pre-sleep Arousal Scale (PSAS)

Timepoint [19]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [20]

Change in pre-sleep cognitive arousal subscale of the Pre-sleep Arousal Scale (PSAS)

Timepoint [20]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [21]

Change in overall score of the World Health Organization Quality of Life – Abbreviated questionnaire (WHOQOL-BREF)

Timepoint [21]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [22]

Change in acceptance of insomnia symptoms measured by Sleep Problem Acceptance Questionnaire (SPAQ)

Timepoint [22]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [23]

Change in Cognitive Fusion Questionnaire (CFQ) scores

Timepoint [23]

End of Phase A (baseline monitoring) to beginning of Phase C (post-intervention monitoring) and at end of Phase C, Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [24]

Change in present moment awareness question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [24]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [25]

Change in values question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [25]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [26]

Change in committed action awareness question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [26]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [27]

Change in self as context question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [27]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [28]

Change in defusion question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [28]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [29]

Change in acceptance question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [29]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [30]

Change in lack of contact with present moment question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [30]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [31]

Change in lack of contact with values question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [31]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [32]

Change in inaction question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [32]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [33]

Change in self as content question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [33]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [34]

Change fusion question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [34]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Secondary outcome [35]

Change in experiential avoidance question measured continuously using Experience Sampling Methodology (ESM)

Timepoint [35]

Phase A (baseline monitoring) to Phase C (post-intervention monitoring) and at Phase D (2-month follow up) and Phase E (6-month follow up)

Eligibility

Key inclusion criteria

Inclusion criteria are being between the age of 18-65 years (to control for age-related sleep difficulties), fluent in English, reporting insomnia symptomology (Insomnia Severity Index (ISI) score greater than 8), having access to a smart phone and internet to complete questionnaires and willingness to attend Bundoora La Trobe University Psychology Clinic for the intervention.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria includes participants unable to complete questionnaires or partake in the intervention due to visual, language, hearing, cognitive deficits or intellectual disabilities, night shift workers, participants diagnosed with a mental health disorder other than anxiety and depression or a sleep disorder other than insomnia (e.g., sleep apnoea), and participants presenting with moderate to high suicide risk.

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)

An allocated research assistant (RA) will be responsible for randomly assigning participants to the three baseline conditions. The RA will contact participants via a central clinic telephone at La Trobe University to inform them of the week of their initial therapy appointment, which will be dependent upon their baseline length.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomly assigned to one of three baseline length conditions (Condition 1: 2 weeks baseline and 4 weeks post, Condition 2: 3 weeks baseline and 3 weeks post, Condition 3: 4 weeks baseline and 2 weeks post) with simple unequal randomisation (3:4:3 allocation) using a computerised random number generator. Each condition will have limits, with condition 1 and 3 having a limit of n = 3 and condition 2 having a limit of n = 4. Due to the nature of the non-concurrent multiple baseline design, each participant will be randomly assigned as they enter the study, following the initial screening, intake interview, and informed consent. Randomisation of the baseline length will allow for an exploration of whether change occurs after each phase starts, rather than if change is a function of other factors, such as if everyone received the same baseline length.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Other

Other design features

This is an experimental study featuring a non-concurrent, randomised multiple-baseline across subjects design followed by a single intervention.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical analysis for primary outcome
Changes in insomnia symptomatology will be analysed using the Reliable Change Index (RCI; Jacobson & Truax, 1991) for each participant. The RCI will provide an indication of the significance of change in individual ISI scores across four time points: the beginning of pre-treatment, the end of baseline and prior to intervention, directly post-intervention, and at the end of the post-treatment phase. A group level analysis will also be conducted using one-way repeated Friedman tests (using all four time points). Significance tests will be followed up using the Wilcoxin signed ranks test, with alpha adjusted for multiple comparisons (Pallant, 2011).

Statistical analyses for secondary outcomes
Sleep components: Visual analyses will be conducted to assess for trends in changes in total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency as reported by the CSD. The Tau-u (Parker et al., 2011) will also be computed in R for each participant’s sleep components to control for baseline trends and compare the statistical significance of trends across phases (p < 0.05). The Tau-u is a non-parametric simple non-overlap controlling for baseline trend.

Quality of Life (QoL), Acceptance of Insomnia & Objective Sleep Quality: Individual RCIs and group level non-parametric statistics (Friedman Tests and Wilcoxin signed ranks) will be used to analyse whether there are statistically significant differences in QoL and acceptance of sleep issues across each trial phase, and to analyse if there are statistically significant differences in actigraphy pre- and post-intervention.

Insomnia symptomatology, subjective sleep quality, anxiety, depression & pre-sleep arousal: Within group analyses for the ISI, PSQI, PSAS and GAD-7 will be conducted across the four time points (pre-baseline, pre-intervention, post-intervention, and follow-up). This data will be analysed using one-way Friedman’s ANOVA, a non-parametric analysis with repeated measures. Any significant results will be further analysed using the Wilcoxon signed ranks test. The RCI will also be used to assess for change in the PSQI, PSAS, GAD-7, and PHQ-9 for each participant across all four time points. Tau-u will also be computed for continuous measures of anxiety and depression, which will be measured in two questions via ESM.

Cognitive Fusion & Experiential Avoidance:
An individual RCI will be computed for each participant to compare cognitive fusion on the CFQ across pre- and post- intervention. A Friedman’s one way ANOVA will be used to compare all four timepoints on the CFQ to examine change at a group level in the total sample. This is a non-parametric test of whether more than two related groups differ on a variable. Tau-U will also be computed for continuous measures of cognitive fusion and experiential avoidance to assess changes from Phase A to the end of Phase C. Including continuous measures of cognitive fusion and experiential avoidance will allow us to assess how these psychological processes change over time across the intervention.

Continuous Assessment Data
Changes in the continuous assessment data will be computed using Tau-u to assess for changes from Phase A to the end of Phase C. This will include assessing changes in psychological flexibility and inflexibility processes, as well as vitality, anxiety, depression, cognitive activity, daytime functioning, and the sleep components (measured through the CSD).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/01/2023

Actual

Date of last participant enrolment

Anticipated

31/05/2023

Actual

Date of last data collection

Anticipated

13/03/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

1 Kingsbury Drive,
Bundoora VIC 3086

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

1 Kingsbury Drive,
Bundoora VIC 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University, Human Research Ethics Committee

Ethics committee address [1]

1 Kingsbury Drive
Bundoora VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2022

Approval date [1]

19/12/2022

Ethics approval number [1]

HEC22352

Summary

Brief summary

Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) is a novel ACT-I/behavioural therapy (BT) intervention originally developed to increase behavioural and psychological flexibility around sleep in autistic adults (Lawson et al., 2022). Behavioural methods aimed at reducing sleep difficulties and improving sleep involve sleep hygiene, self-monitoring, relaxation, and sleep restriction. 

This trial aims to investigate whether SLEAPI delivered in an individual format for non-autistic adults promotes significant improvements on insomnia symptomology severity. This study will investigate the efficacy of the SLEAPI intervention on improving (1) quality of life; (2) acceptance of sleep issues; (3) individual sleep components; (4) perceived sleep quality; and reducing (5) anxiety and depression and (6) pre-sleep arousal among non-autistic adults. 

A non-concurrent multiple baseline design will be used to track the effects of the intervention. The use of a multiple baseline design allows participants in the longer baseline phases to act as controls/comparators for those in the intervention phase. In this design all participants will receive the same intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lauren Lawson

Address

Department of Psychology, Counselling & Therapy
School of Psychology and Public Health
La Trobe University
1 Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 394792409

Fax

[email protected]

Contact person for public queries

Name

Lauren Lawson

Address

Department of Psychology, Counselling & Therapy
School of Psychology and Public Health
La Trobe University
1 Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 394792409

Fax

[email protected]

Contact person for scientific queries

Name

Lauren Lawson

Address

Department of Psychology, Counselling & Therapy
School of Psychology and Public Health
La Trobe University
1 Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 394792409

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

Due to the small number of participants and the large amount of data collected, data will not be publicly available to ensure confidentiality and privacy of trial participants.

What supporting documents are/will be available?

Doc. No.	Type	Email
17924	Study protocol	[email protected]
17925	Statistical analysis plan	[email protected]
17926	Informed consent form	[email protected]
17927	Ethical approval	[email protected]

Results publications and other study-related documents

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No additional documents have been identified.

Trial Review

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