Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000067572
Ethics application status
Approved
Date submitted
12/12/2014
Date registered
23/01/2015
Date last updated
23/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy for Insomnia Among Older Adults With Depression
Scientific title
Effect of Cognitive Behaviour Therapy on Symptom Severity in Older Adults Experiencing Insomnia and Depression in a Community Mental Health Setting: A Randomised Controlled Trial
Secondary ID [1] 285810 0
Nil
Universal Trial Number (UTN)
U1111-1165-0188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 293710 0
Depression 293784 0
Condition category
Condition code
Mental Health 294028 294028 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Cognitive Behaviour Therapy for Insomnia (CBT-I):
Participants who are randomly allocated to participate in the Cognitive Behaviour Therapy for insomnia group will be asked to attend 8 weekly, 60-90 minute treatment sessions that involve learning more about their sleep pattern, and identifying unhelpful habits that may be contributing towards their sleep difficulties. Participants will learn several skills that aim to improve their sleep pattern and sleep quality. They will also be provided with information and worksheets during the program which are designed to help improve their sleep pattern. Participating in this form of therapy requires time and commitment. It will take perseverance to make sustainable changes to their sleep habits, and therefore the strategies that they will learn need to be practiced each day during the trial. Participants in this group will be supported by two qualified therapists who have received specialised training and supervision in this therapy. The 8 treatment sessions will be provided in small groups at the local mental health service venue. This will give participants an opportunity to meet other people who are experiencing similar problems and support each other in making changes to their sleep habits.

2. Cognitive Behaviour Therapy for Insomnia and Depression (CBT-I-D)
Participants who are randomly allocated to the Cognitive Behaviour Therapy for insomnia and depression group will receive the same program as the group described above. This group, however, will include additional strategies that are specifically designed to also improve their mood. This will involve assisting to increase their level of daily meaningful activity and help them to refocus their attention on positive thoughts rather than depressive negative thoughts.
Intervention code [1] 290796 0
Treatment: Other
Intervention code [2] 290847 0
Behaviour
Comparator / control treatment
3. Psychoeducation Control group.
This condition includes providing 60-90 minute supportive education sessions about sleep and mood problems once a week over 8 weeks. This group contains no active treatment strategies of CBT for insomnia. Each session will also be held in small groups and co-facilitated by two qualified therapists.
Control group
Active

Outcomes
Primary outcome [1] 293803 0
Insomnia Severity (Insomnia Severity Index)
Timepoint [1] 293803 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Primary outcome [2] 293880 0
Sleep Quality (Consensus Sleep Diary)
Timepoint [2] 293880 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Primary outcome [3] 293881 0
Depression Severity (Geriatric Depression Scale)
Timepoint [3] 293881 0
Baseilne (Pre), Week 8 (Post), 6 Month Follow Up
Secondary outcome [1] 311959 0
Anxiety Severity (Geriatric Anxiety Inventory)
Timepoint [1] 311959 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Secondary outcome [2] 312078 0
Dysfunctional Beliefs About Sleep (DBAS scale)
Timepoint [2] 312078 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Secondary outcome [3] 312079 0
Hopelessness (Beck Hopelessness Scale)
Timepoint [3] 312079 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Secondary outcome [4] 312287 0
Subjective Health (EQ-5)
Timepoint [4] 312287 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up
Secondary outcome [5] 312288 0
Primary Outcome:
Clinical Diagnosis (Yes/No) using the MINI Structured Interview and SLEEP-50
Timepoint [5] 312288 0
Baseline (Pre), Week 8 (Post), 6 Month Follow Up

Eligibility
Key inclusion criteria
Comorbid Insomnia Disorder
Major Depressive Disorder
Aged Persons Community Mental Health Setting
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current Crisis/High Risk/Psychosis
Cognitive Impairment
Unstable dose of medication
ECT
Private Therapist

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)
Participants will be invited to participate in the trial via their mental health case manager. This will involve providing participants with an information pack about the trial (e.g., invitation brochure, plain language statement, consent form). Once participants have read the documents and have consented to participate, they will undergo a 2-step eligibility screening process. The first step involves completing a brief insomnia symptom diagnostic screen over the phone. Participants who have current insomnia will be invited to complete a face to face interview. Participants who are eligible for the trial after this second step will be allocated to group/cluster (n=6), which has been randomly generated via cluster/block randomisation. Allocation concealment involved contacting the holder of the allocation schedule who was “off-site”. Participants will have a 2 in 3 chance of being allocated to a CBT group, and a 1 in 3 chance of being allocated to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster/Block Randomisation: Permuted block randomisation was calculated and implemented by an independent statistical researcher at Federation University.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Cluster/Block: Participants are sequentially allocated to a condition (n=6), whether it be a control or intervention group, where the cluster groups have been randomly allocated and concealed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Data will be entered, screened, and analysed using SPSS.
- Repeated measures MANCOVA will be implemented to explore differences between groups and over time, and calculate effect sizes to investigate treatment effect.
- The projected sample size calculation was conducted using power analysis involving modest statistical assumptions. This was cross-referenced with respected RCTs in the field to obtain a minimum total number of participants and minimum number of participants per treatment condition.
- Statistical power analysis was based on an examination of treatment-time interactions in a repeated measures analysis of covariance, with adjustment for confounders. It was specified a “clinically relevant” difference of 2 points between each of the three treatment conditions in the change in adjusted mean of the primary measure (ISI) from pre to post intervention, with no further change at follow-up, and assumed a “within-treatments” SD of 4.1 points (Bastein et al., 2001). Under the assumptions of constant correlation over time, a conservatively estimated magnitude of correlation (r = 0.5) (Frison & Pocock, 1992), with allowance for a design effect (Donner & Klar 2000) of 1.16 due to clustering of participants within treatment groups (based on an assumed cluster size of 5-6 and a conservatively estimated intra class correlation of 0.04 (Adams et al., 2004)), with a significance level of 5% and 80% power, the projected sample size, calculated using GPower software (Faul et al., 2007) is N = 70.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
26/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3243 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 9070 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 290406 0
University
Name [1] 290406 0
Federation University Australia
Country [1] 290406 0
Australia
Primary sponsor type
University
Name
Federation University Australia
Address
Federation University Australia
University Drv.
Mt Helen VIC 3350
Country
Australia
Secondary sponsor category [1] 289125 0
Hospital
Name [1] 289125 0
Latrobe Regional Hospital
Address [1] 289125 0
Latrobe Regional Hospital
Princes Hwy.
Traralgon VIC 3844
Country [1] 289125 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292099 0
HREC Federation University Australia
Ethics committee address [1] 292099 0
Ethics committee country [1] 292099 0
Australia
Date submitted for ethics approval [1] 292099 0
Approval date [1] 292099 0
20/05/2014
Ethics approval number [1] 292099 0
E14-042 (Federation University)
Ethics committee name [2] 292100 0
HREC Latrobe Regional Hospital
Ethics committee address [2] 292100 0
Ethics committee country [2] 292100 0
Australia
Date submitted for ethics approval [2] 292100 0
Approval date [2] 292100 0
14/05/2014
Ethics approval number [2] 292100 0
2014-02 LNR (LRH)

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

Contacts
Principal investigator
Name 53362 0
Mr Paul Sadler
Address 53362 0
LRH Aged Persons Mental Health Service
Wonthaggi Hospital
Graham St
Wonthaggi VIC 3995
Country 53362 0
Australia
Phone 53362 0
+61 3 5671 4515
Fax 53362 0
+61 3 56714520
Email 53362 0
[email protected]
Contact person for public queries
Name 53363 0
Paul Sadler
Address 53363 0
LRH Aged Persons Mental Health Service
Wonthaggi Hospital
Graham St
Wonthaggi VIC 3995
Country 53363 0
Australia
Phone 53363 0
+61 3 5671 4515
Fax 53363 0
+61 3 5671 4520
Email 53363 0
[email protected]
Contact person for scientific queries
Name 53364 0
Suzanne McLaren
Address 53364 0
Federation University Australia
School of Health Sciences
Head of Psychology
University Drive.
Mt Helen VIC 3350
Country 53364 0
Australia
Phone 53364 0
+61 3 5327 9628
Fax 53364 0
Email 53364 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
SourceTitleYear of PublicationDOI
EmbaseCognitive behaviour therapy for older adults experiencing insomnia and depression in a community mental health setting: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-1066-6
EmbaseCognitive behavior therapy for older adults with insomnia and depression: A randomized controlled trial in community mental health services.2018https://dx.doi.org/10.1093/sleep/zsy104
N.B. These documents automatically identified may not have been verified by the study sponsor.