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Trial registered on ANZCTR


Registration number
ACTRN12612000223831
Ethics application status
Approved
Date submitted
17/02/2012
Date registered
22/02/2012
Date last updated
24/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of sleep disturbances in individuals with insomnia and depression.
Scientific title
Comparison between sleep education and cognitive behavioural therapy for insomnia (CBT-I) in co-morbid insomnia and depression.
Secondary ID [1] 279952 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 285866 0
Depression 285867 0
Condition category
Condition code
Mental Health 286052 286052 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behavioural therapy for insomnia(CBT-I): 4 one-on-one face-to-face sessions of CBT-I are conducted with a psychologist across 8 weeks of treatment (one 50 minute session every two weeks). Session one consists of sleep education and sleep hygiene recommendations as well as an introduction to relaxation techniques. Session two focuses on the importance of sleep scheduling and discusses the rationale and instructions for both stimulus control and sleep restriction. It also introduces progressive muscle relaxation. Session three looks to adjust the sleep schedule, overcome adherence issues and focuses on cognitive restructuring around unhelpful beliefs and attitudes about sleep. It also has an imagery relaxation exercise. The fourth and last session Assesses gains made across the treatment, looks at maintenance strategies and relapse prevention, and concludes with a mindfulness relaxation exercise.
A 3 month-follow up is then conducted to monitor changes over time.
Intervention code [1] 284280 0
Treatment: Other
Intervention code [2] 284281 0
Lifestyle
Intervention code [3] 284282 0
Behaviour
Comparator / control treatment
The information only control group attends the same number of sessions (4 sessions across 8 weeks) and receives the same documentation of information (sleep education, sleep hygiene recommendations, sleep scheduling rationale and instructions, relaxation techniques and cognitive techniques) as the CBT-I group. However, they are unable to go over the information with the researcher or ask any treatment related questions during their participation in the study. Following their 3-month follow-up, they will be offered up to 4 sessions of CBT-I free of charge, although data will not be collected for the study during this time.
Control group
Active

Outcomes
Primary outcome [1] 286532 0
Beck Depression Inventory, Second Edition (BDI-II): This will be used as a primary outcome measure. It is a 21-item self-report measure that assesses the severity of various commonly reported symptoms of depression over a two week period. It has a 4 point scale for each item ranging from 0-3. Total scores range from 0-63. It has high internal consistency, high content validity, high validity in differentiating between depressed and non-depressed subjects, and sensitivity to change.
Timepoint [1] 286532 0
The BDI-II will be taken on a total of six occasions: At the screening session, at sessions 1, 2, and 3, at post-treatment (end of session 4), and 3 months post-therapy.
Primary outcome [2] 286533 0
Insomnia Severity Index (ISI): This will be used as the primary outcome measure for determining changes in insomnia severity across the study. This self-rated measure consists of 7 items that are scored from 0 to 4, with 0 = no problem, very satisfied, not at all noticeable, not at all worried, and not at all interfering to 4 = very severe problem, very dissatisfied, very much noticeable, very much worried, and very much interfering. The sum of these items produces an overall score (range = 0-28), with 0-14 indicating no clinically significant (or sub-threshold) insomnia, 15-21 indicating a moderate severity of clinical insomnia, and 22-28 indicating severe insomnia.
Timepoint [2] 286533 0
The ISI will be taken on a total of six occasions: During baseline data collection, at sessions 1, 2, and 3, at post-treatment (end of session 4), and 3 months post-therapy.
Secondary outcome [1] 296094 0
Fatigue Severity Scale (FSS): The FSS is a 9-item general fatigue scale that assesses the behavioural consequences, rather than the symptoms of fatigue, and the impact of fatigue on daily functioning. The FSS has acceptable internal consistency, stability over time, and sensitivity to clinical changes.
Timepoint [1] 296094 0
The FSS will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.
Secondary outcome [2] 296095 0
Epworth Sleepiness Scale (ESS): This daytime sleepiness measure is widely used as an index of sleep propensity in adults. Participants rate how likely they would be to doze off in eight situations, in their usual way of life, on a scale from 0 = would never doze, to 3 = high chance of dozing. Total scores range from 0-24.
Timepoint [2] 296095 0
The ESS will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.
Secondary outcome [3] 296096 0
Pittsburgh Sleep Quality Index (PSQI): This instrument is a self-rated questionnaire which assesses sleep quality and disturbances over a one-month period. Seven component scores (subjective sleep quality, sleep latency, sleep duaration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score are generated from 19 questions. The global PSQI score greater than 5 yielded a diagnostic sensitivity of 86.5% (kappa = 0.75, p < .001) in distinguishing good and poor sleepers.
Timepoint [3] 296096 0
The PSQI will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.
Secondary outcome [4] 296097 0
Actigraphic sleep parameters. Actiwatch (Respironics, USA) is a wrist activity monitor (16g) with an integrated light sensor (range 0.1 TO 150,000 lux). Several sleep parameters can be derived from actigraphic data, including sleep duration, sleep efficiency (total sleep time divided by time in bed) and number of awakenings.
Timepoint [4] 296097 0
Sleep parameters will be collected during the baseline period every night for two weeks and for every night across the 8 weeks of treatment.
Secondary outcome [5] 296098 0
The Pittsburgh sleep diary (PSD): This instrument records several subjective sleep measures across a 2-week period, including bedtime (BT), sleep onset latency (SOL; time taken to get to sleep), number of awakenings (NOA), wake after sleep onset (WASO - time awake during the sleep period), and rising time (RT). The collection of these variables also allow for further subjective sleep measures to be calculated, including time in bed (TIB = difference between BT and RT), total sleep time (TST = TIB - SOL - WASO) and sleep efficiency (SE = TST / TIB). These variables allow for progress to be monitored and for feedback to be given to participants. The SE findings also help determine TIB prescriptions for sessions 2, 3 and 4 (based on the bed restriction instructions).
Timepoint [5] 296098 0
The PSD will be completed by participants upon waking each day during the two-week baseline data collection, across the 8 weeks of treatment, and two weeks prior to the 3-month post-treatment session.
Secondary outcome [6] 296099 0
Diagnostic Interview of Sleeping Disorders (DISD): The DISD is a structured clinical interview that asks several questions about the severity of an individual's sleeping problem, their typical current sleep pattern, their history of insomnia, whether or not they exhibit symptoms of other sleep disorders, their ideal circadian rhythm, usage of medicinal or other sleeping aids, their sleep hygiene practices, their nocturnal cognitions, and the relationship between their sleep and mood to delineate if their insomnia is primary, secondary or co-morbid.
Timepoint [6] 296099 0
The DISD is only given once: During the initial screening session, and is used to help determine eligibility for the study.
Secondary outcome [7] 296100 0
The Multivariate Apnoea Risk Index (MAP index): This 13-item screening tool assesses for the likely prevalence of sleep apnoea or other primary sleep disorders. Responses are rated on the frequency of symptoms experienced or noticed by others per week over the past month, with 0 = never; 1 = rarely, less than once a week; 2 = 1-2 times per week; 3 = 3-4 times per week; 4 = 5-7 times per week; and DK = Don't know. The sum of these items are then divided by the number of responses to obtain the overall symptom score (range 0-4), with a higher score representing a greater risk of apnoea. Any participants that are considered to be high-risk of a primary sleep disorder will be informed of their results at the conclusion of their participation in the study and will be encouraged to discuss these findings with their general practitioner or a sleep specialist.
Timepoint [7] 296100 0
The MAP index is only given once: During the initial screening session.
Secondary outcome [8] 296101 0
The Depression Anxiety Stress Scales (DASS-21): The DASS-21 consists of three separate 7-item scales that aim to delineate the core features of depression, anxiety and stress, with the overall 21-item scale being a general measure of negative affectivity. Each item is rated on a 4-point Likert scale from 0 to 3 based on how much each statement (item) applied to the participant over the past week. Scores for each scale are summed up and multiplied by 2 to obtain the final rating (range = 0-42), with higher scores indicating a greater level of severity.
Timepoint [8] 296101 0
The DASS-21 will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.
Secondary outcome [9] 296102 0
Dysfunctional Beliefs about Sleep Scale (DBAS-16): This instrument is a 16-item self-report questionnaire that is used to examine the strength of several unhelpful beliefs and attitudes that are thought to contribute to the maintenance of insomnia. Each item is rated on a scale from 0 (= strongly disagree) to 10 (=strongly agree) based on how much the participant agrees with each statement. The item scores are then summed to obtain an overall DBAS-16 score, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.
Timepoint [9] 296102 0
The DBAS-16 will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.
Secondary outcome [10] 296103 0
Sleep Hygiene Index (SHI): This instrument is used to assess sleep hygiene practices. Each of the 13-items are rated on a 5-point Likert scale from 0 to 4 based on how frequently the participant engages in specific poor sleep hygiene behaviour, with 0 = never and 4 = always. The item scores are summed to obtain an overall SHI score, with higher scores indicating poorer sleep hygiene practices.
Timepoint [10] 296103 0
The SHI will be taken on three occasions: During baseline data collection, at post-treatment (end of session 4), and 3-months post treatment.

Eligibility
Key inclusion criteria
Individuals with Major Depressive Disorder and chronic insomnia who have been prescribed with and have adhered to standard antidepressant (SSRI) treatment for at least 6 weeks.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not take any medication for insomnia in the 14 days prior to the screening visit and are requested to not undertake any other ongoing types of treatment (including over-the-counter medications or herbs) or therapy (including alternative therapy) of claimed efficacy for depression or insomnia at any point in the study. Participants will be excluded if they have had electro-convulsive therapy (ECT) in the prior year and if they exhibit any current active suicidal potential or psychotic features. Diagnosis of seasonal affective disorder or major depressive disorder (MDD) with a seasonal pattern will be exclusionary. Participants must not have any other co-morbid psychiatric conditions, or any conditions incompatible with standard antidepressants (SSRIs). Participants will be excluded if they have a current diagnosis of any other primary sleep disorder or any uncontrolled medical conditions. Participants with inadequate English language fluency will also be excluded from the study.

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)
Any individuals interested in participating in the project are invited to attend a screening session, where they read and sign the Participant Information and Consent Form, answer questions, and fill in questionnaires to determine their eligibility for the study. Once eligibility criteria has been met at the beginning of the first session, participants are randomly allocated to either the treatment or the control condition. Randomisation is conducted by a computer program off-site and the allocation schedule is only known by a research assistant that is not involved with the project. Once eligibility criteria is met, the researcher conducting the treatment sessions must contact the holder of the allocation schedule to find out what group the participant has been assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5011 0
3000
Recruitment postcode(s) [2] 5012 0
3121
Recruitment postcode(s) [3] 5013 0
3181
Recruitment postcode(s) [4] 5014 0
3800

Funding & Sponsors
Funding source category [1] 284760 0
University
Name [1] 284760 0
Monash University
Country [1] 284760 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Shantha Rajaratnam
Address
Monash University, School of Psychology and Psychiatry, Building 17, Clayton Campus, Monash University, VIC 3800
Country
Australia
Secondary sponsor category [1] 283625 0
Individual
Name [1] 283625 0
Dr Tracey Sletten
Address [1] 283625 0
Monash University, School of Psychology and Psychiatry, Building 17, Clayton Campus, Monash University, VIC 3800
Country [1] 283625 0
Australia
Secondary sponsor category [2] 283626 0
Individual
Name [2] 283626 0
Dr Moira Junge
Address [2] 283626 0
Monash University, School of Psychology and Psychiatry, Building 17, Clayton Campus, Monash University, VIC 3800
Country [2] 283626 0
Australia
Other collaborator category [1] 260549 0
Individual
Name [1] 260549 0
Professor David Clarke
Address [1] 260549 0
School of Psychology and Psychiatry, Building 17, Clayton Campus, Monash University, Victoria 3800
Country [1] 260549 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286737 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 286737 0
Ethics committee country [1] 286737 0
Australia
Date submitted for ethics approval [1] 286737 0
Approval date [1] 286737 0
09/05/2011
Ethics approval number [1] 286737 0
CF11/0688 - 2011000333

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33784 0
Address 33784 0
Country 33784 0
Phone 33784 0
Fax 33784 0
Email 33784 0
Contact person for public queries
Name 17031 0
Damon Ashworth
Address 17031 0
School of Psychology and Psychiatry, Building 17, CLAYTON CAMPUS, Monash University, Victoria 3800
Country 17031 0
Australia
Phone 17031 0
(+61) (03) 9905 3952
Fax 17031 0
Email 17031 0
Damon.Ashworth@monash.edu
Contact person for scientific queries
Name 7959 0
Associate Professor Shantha Rajaratnam
Address 7959 0
School of Psychology and Psychiatry, Building 17, CLAYTON CAMPUS, Monash University, Victoria 3800
Country 7959 0
Australia
Phone 7959 0
(+61) (03) 9905 3934
Fax 7959 0
Email 7959 0
Shantha.Rajaratnam@monash.edu

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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