Trial Review

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
ACTRN12616000695404
Ethics application status
Approved
Date submitted
20/04/2016
Date registered
26/05/2016
Date last updated
5/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Behavioral GroupTherapy for Insomnia (CBGT-I) in College Students
Scientific title
Cognitive Behavioral GroupTherapy for Insomnia (CBGT-I) in College Students
Secondary ID [1] 289054 0
none
Universal Trial Number (UTN)
U1111-1182-1460
Trial acronym
CBGTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia 298487 0
Condition category
Condition code
Mental Health 298576 298576 0 0
Other mental health disorders
Neurological 298718 298718 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes 4 weekly meetings, 1.5 hours each. College students screened for insomnia attend group therapy based on standard cognitive behavioral therapy for insomnia protocol. Participants complete weekly sleep diaries throughout the intervention. They are educated about sleep hygiene principles, stimulus control and sleep restriction therapies and are encouraged to alter their sleep practices based on these principles. Cognitive therapy for insomnia and relaxation therapies (e.g., mindfullness) are also introduced. Weekly follow up is conducted based on sleep diaries. Primary investigator (who completed official CBT and CBT- Insomnia training) together with doctoral student (registered nurse, supervised by the PI for CBT-Insomnia) will deliver the intervention.
Intervention code [1] 294542 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298071 0
Change in insomnia severity index (ISI) from baseline.
Timepoint [1] 298071 0
6 weeks post intervention
Secondary outcome [1] 323084 0
Change in the Pre Sleep Arousal Scale from baseline.
Timepoint [1] 323084 0
6 weeks post intervention
Secondary outcome [2] 323454 0
Change in self perceived stress from baseline. The perceived stress scale (Cohen 1988) is a 10 item questionnaire with a 5-point likert scale. Responses are summed to achieve a total score.
Timepoint [2] 323454 0
6-weeks post treatment
Secondary outcome [3] 323455 0
Change in sense of coherence from baseline. The sense of coherence questionnaire (Antonovsky, 1983, 1987) short form is a 13-item form with a 7-point likert scale. Items are summed for a total score.
Timepoint [3] 323455 0
6-weeks post treatment
Secondary outcome [4] 323456 0
change in optimism from baseline. The Life Orientation test ((Scheier et al., 1994) is a 6-item questionnaire with a 5-point likert scale. scores are summed for the total score.
Timepoint [4] 323456 0
6-weeks post treatment
Secondary outcome [5] 323457 0
change in perfectionism from baseline. The Perfectionism Cognitions Inventory- PCI (Flett et al., 1998) is a 25-item questionnaire with a 5-point likert scale. Items are summed for the total score.
Timepoint [5] 323457 0
6-weeks post treatment

Eligibility
Key inclusion criteria
college students, insomnia severity index >7
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diagnosed sleep disorder or mental disorder, chronic pain, previous CBT-I intervention, pregnany, child <1-year old,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
29/03/2016
Date of last data collection
Anticipated
Actual
15/06/2016
Sample size
Target
60
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 7832 0
Israel
State/province [1] 7832 0

Funding & Sponsors
Funding source category [1] 293431 0
Self funded/Unfunded
Name [1] 293431 0
Country [1] 293431 0
Primary sponsor type
University
Name
University of Haifa
Address
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel
Zip code: 3498838
Country
Israel
Secondary sponsor category [1] 292253 0
None
Name [1] 292253 0
Address [1] 292253 0
Country [1] 292253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294875 0
Faculty of Social Welfare and Health Sciences committee, Haifa Israel
Ethics committee address [1] 294875 0
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel
Zip code: 3498838
Ethics committee country [1] 294875 0
Israel
Date submitted for ethics approval [1] 294875 0
10/03/2014
Approval date [1] 294875 0
06/04/2014
Ethics approval number [1] 294875 0
22142

Summary
Brief summary
The study aims to assess the efficacy of cognitive behavioral group therapy for insomnia (CBGT-I) on sleep (main outcome) and hyper-arousal (secondary outcome) in college students with insomnia. It is hypothesized that CBGT-I, administered for 4 successive weeks will improve sleep quality and reduce hyper-arousal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65310 0
Prof Tamar Shochat
Address 65310 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel
Zip code: 3498838
Country 65310 0
Israel
Phone 65310 0
+972 4 8288010
Fax 65310 0
Email 65310 0
[email protected]
Contact person for public queries
Name 65311 0
Mrs Zahava Moked
Address 65311 0
University of Haifa
Department of Nursing
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel
Zip code: 3498838
Country 65311 0
Israel
Phone 65311 0
+972 4 6304615
Fax 65311 0
Email 65311 0
[email protected]
Contact person for scientific queries
Name 65312 0
Prof Tamar Shochat
Address 65312 0
University of Haifa
Department of Nursing
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel
Zip code: 3498838
Country 65312 0
Israel
Phone 65312 0
+972 4 8288010
Fax 65312 0
Email 65312 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
No additional documents have been identified.