Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001000897
Ethics application status
Approved
Date submitted
14/09/2012
Date registered
18/09/2012
Date last updated
18/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Rural SHADE – feasibility and acceptability pilot study of an internet-delivered intervention for co-occurring depression and alcohol use in rural community residents.
Scientific title
Pilot study of an internet-delivered intervention for co-occurring depression and alcohol use in rural community residents.
Secondary ID [1] 281231 0
n/a
Universal Trial Number (UTN)
U1111-1134-7067
Trial acronym
Rural SHADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287418 0
Alcohol use 287419 0
Condition category
Condition code
Mental Health 287753 287753 0 0
Depression
Mental Health 287754 287754 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we will pilot test an internet-delivered intervention to address co-occurring depression and alcohol use for people residing in rural and remote areas. Participants reporting elevated depressive symptoms and alcohol use exceeding the current Australian guidelines will receive ten sessions of cognitive-behavioural therapy delivered via an internet-based program, with weekly telephone support from trained members of the project team. The sessions take approximately one hour to complete and participants will be asked to complete two sessions per week, over a five week period.
Intervention code [1] 285698 0
Behaviour
Intervention code [2] 285715 0
Treatment: Other
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287988 0
Depressive symptoms as measured on the depression scale of the DASS-21.
Timepoint [1] 287988 0
Baseline and 10 weeks post-baseline.
Primary outcome [2] 287989 0
Alcohol use as measured by the Time Line Follow Back.
Timepoint [2] 287989 0
Baseline and 10 weeks post-baseline
Secondary outcome [1] 299192 0
Suicidal ideation as measured by item 9 of the PHQ
Timepoint [1] 299192 0
Baseline and Follow up assessment (10 weeks post-baseline)
Secondary outcome [2] 299193 0
Substance use as measured by the Cannabis OTI, Amphetamine OTI and Tobacco OTI
Timepoint [2] 299193 0
Baseline and Follow up assessment (10 weeks post-baseline)
Secondary outcome [3] 299208 0
Caffeine use as measured through items that record daily intake of tea, coffee and caffeinated drinks.
Timepoint [3] 299208 0
Baseline and Follow up assessment (10 weeks post-baseline)
Secondary outcome [4] 299209 0
Computer anxiety as measured through the Computer anxiety rating scale (CARS-C Form C)
Timepoint [4] 299209 0
Baseline and Follow up assessment (10 weeks post-baseline)
Secondary outcome [5] 299210 0
Computer thoughts as measured by the Computer thoughts survey scale (CTS-C Form C)
Timepoint [5] 299210 0
Baseline and Follow up assessment (10 weeks post-baseline)
Secondary outcome [6] 299211 0
Perceptions of computer delivered treatment as measured through a qualitative interview
Timepoint [6] 299211 0
Follow up assessment

Eligibility
Key inclusion criteria
Participants will be recruited from the Australian Rural Mental Health Study (ARMHS). Participants of ARMHS are those that reside in rural or remote areas (non-Metropolitan) in New South Wales, specifically the Greater Western, Hunter New England or North Coast health regions. They were recruited to ARMHS using random selection from the electoral roll and had to reside in a house. Potential participants for the present project will be identified from the information gathered in the 3 year follow up assessment for ARMHS. Potential eligibility will be met by those with:
- elevated depressive symptoms (as indicated by a Patient Health Questionnaire-9, PHQ-9, with a score greater than 5) or current suicidal ideation (indicated by a score greater than or equal to 1 on item 9 of the PHQ-9);
and,
- Hazardous consumption of alcohol (indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of >= 8) at the time of assessment; and,
- Access to telephone and internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) any participant who does not meet the criteria for elevated depressive symptoms ; (b) people who are not using alcohol above recommended levels.

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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5741 0
2337
Recruitment postcode(s) [2] 5742 0
2340
Recruitment postcode(s) [3] 5743 0
2360
Recruitment postcode(s) [4] 5744 0
2400
Recruitment postcode(s) [5] 5745 0
2440
Recruitment postcode(s) [6] 5746 0
2441
Recruitment postcode(s) [7] 5747 0
2444
Recruitment postcode(s) [8] 5748 0
2446
Recruitment postcode(s) [9] 5749 0
2454
Recruitment postcode(s) [10] 5750 0
2456
Recruitment postcode(s) [11] 5751 0
2460
Recruitment postcode(s) [12] 5752 0
2462
Recruitment postcode(s) [13] 5753 0
2478
Recruitment postcode(s) [14] 5754 0
2480
Recruitment postcode(s) [15] 5755 0
2481
Recruitment postcode(s) [16] 5756 0
2482
Recruitment postcode(s) [17] 5757 0
2483
Recruitment postcode(s) [18] 5758 0
2648
Recruitment postcode(s) [19] 5759 0
2566
Recruitment postcode(s) [20] 5760 0
2672
Recruitment postcode(s) [21] 5761 0
2787
Recruitment postcode(s) [22] 5762 0
2794
Recruitment postcode(s) [23] 5763 0
2795
Recruitment postcode(s) [24] 5764 0
2800
Recruitment postcode(s) [25] 5765 0
2820
Recruitment postcode(s) [26] 5766 0
2824
Recruitment postcode(s) [27] 5767 0
2825
Recruitment postcode(s) [28] 5768 0
2835
Recruitment postcode(s) [29] 5769 0
2840
Recruitment postcode(s) [30] 5770 0
2873
Recruitment postcode(s) [31] 5771 0
2880
Recruitment postcode(s) [32] 5772 0
3502

Funding & Sponsors
Funding source category [1] 286009 0
Charities/Societies/Foundations
Name [1] 286009 0
BeyondBlue
Country [1] 286009 0
Australia
Funding source category [2] 286010 0
Other Collaborative groups
Name [2] 286010 0
Hunter Institute of Mental Health
Country [2] 286010 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 284829 0
University
Name [1] 284829 0
University of New South Wales
Address [1] 284829 0
Kensington, NSW 2052
Country [1] 284829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288058 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 288058 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Ethics committee country [1] 288058 0
Australia
Date submitted for ethics approval [1] 288058 0
Approval date [1] 288058 0
21/08/2012
Ethics approval number [1] 288058 0
H-2011-0339

Summary
Brief summary
In this study, we will pilot test an internet-delivered intervention to address co-occurring depression and alcohol use for people residing in rural and remote areas. Participants reporting elevated depressive symptoms and alcohol use exceeding the current Australian guidelines will receive ten sessions of cognitive-behavioural therapy delivered via an internet-based program, with weekly telephone support from a trained member of the research team. The primary outcomes are depression and alcohol use at ten weeks post-baseline.
Trial website
www.theshadeproject.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34712 0
Address 34712 0
Country 34712 0
Phone 34712 0
Fax 34712 0
Email 34712 0
Contact person for public queries
Name 17959 0
Dr Frances Kay-Lambkin
Address 17959 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country 17959 0
Australia
Phone 17959 0
+612 40335690
Fax 17959 0
Email 17959 0
[email protected]
Contact person for scientific queries
Name 8887 0
Dr Frances Kay-Lambkin
Address 8887 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country 8887 0
Australia
Phone 8887 0
+612 40335690
Fax 8887 0
Email 8887 0
[email protected]

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