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Trial registered on ANZCTR


Registration number
ACTRN12610000725066
Ethics application status
Approved
Date submitted
30/08/2010
Date registered
31/08/2010
Date last updated
31/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the effects of a support group intervention on symptoms of depression, anxiety and burden in spouses/partners of aged care residents
Scientific title
A randomised controlled trial to assess the effectiveness of a support group intervention in the reduction of symptoms of depression, anxiety and burden in spouses/partners of aged care residents
Secondary ID [1] 252595 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 258090 0
Anxiety 258091 0
Burden on spouses/partners of aged care residents 258092 0
Condition category
Condition code
Mental Health 258271 258271 0 0
Depression
Mental Health 258272 258272 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) an immediate treatment group, or 2) a delayed treatment group, also known as a waitlist control group (beginning treatment approximately 10 weeks after the immediate treatment group begins). Treatment entails weekly 2 hour support groups over 8 weeks that are facilitated by a psychologist. The groups will provide a forum where spouses can share relevant information and personal experiences relating to their shared circumstance of having a spouse/partner living in an aged care facility, and will cover topics and provide education around issues relevant to the caregiving experience, such as coping and communication strategies. Study questionnaires will be completed by all participants at two time points approximately 9 weeks apart. For the immediate treatment group, these time points will occur pre- and post-treatment. For the waitlist control group, both time points will occur before treatment.
Intervention code [1] 257118 0
Other interventions
Intervention code [2] 257121 0
Treatment: Other
Intervention code [3] 257122 0
Lifestyle
Comparator / control treatment
The delayed treatment group, also known as a waitlist control group (beginning treatment approximately 10 weeks after the immediate treatment group begins)
Control group
Active

Outcomes
Primary outcome [1] 259109 0
Mean depression score on the Center for Epidemiologic Studies Depression Scale (CES-D)
Timepoint [1] 259109 0
Administered immediately pre-treatment and immediately post-treatment
Primary outcome [2] 259110 0
Mean anxiety score on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 259110 0
Administered immediately pre-treatment and immediately post-treatment
Primary outcome [3] 259111 0
Mean burden score on the Zarit Burden Interview (ZBI)
Timepoint [3] 259111 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [1] 265415 0
Mean psychological distress score on the Kessler Psychological Distress Scale (K10)
Timepoint [1] 265415 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [2] 265416 0
Mean self-efficacy score on the Proactive Coping Inventory (PCI)
Timepoint [2] 265416 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [3] 265417 0
Mean worry score on the Penn State Worry Questionnaire (PSWQ)
Timepoint [3] 265417 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [4] 265418 0
Mean loneliness score on the UCLA Loneliness Scale
Timepoint [4] 265418 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [5] 265419 0
Mean distress score on the Neuropsychiatric Inventory (NPI)
Timepoint [5] 265419 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [6] 265420 0
Mean scores for various coping styles on the Brief COPE scale
Timepoint [6] 265420 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [7] 265421 0
Mean social support score on the Social Support Questionnaire (SSQ) - Short Form
Timepoint [7] 265421 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [8] 265422 0
Mean social participation score on the Participation Scale (van Brakel et al., 2006)
Timepoint [8] 265422 0
Administered immediately pre-treatment and immediately post-treatment
Secondary outcome [9] 265423 0
Mean life satisfaction score on the Satisfaction With Life Scale (SWLS)
Timepoint [9] 265423 0
Administered immediately pre-treatment and immediately post-treatment

Eligibility
Key inclusion criteria
- Must be the spouse/partner of an aged care resident who has resided at their current facility for at least 3 months
- Must be living independently
- Must be able to speak fluent English
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Staff at each aged care facility provide explanatory statements and consent forms to eligible spouses. Interested spouses post signed consent forms to the project coordinator, who then contacts spouses by phone to confirm eligibility and schedule initial interviews. Once all interviews are conducted at a facility, the facility is then allocated to immediate start or delayed treatment based on the contents of a folded piece of paper drawn out of an opaque container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to groups is determined using clustered randomisation i.e. participants are allocated to groups based on the aged care facility at which their spouse/partner resides. Each facility is assigned as either an immediate start facility or a waitlist facility based on simple randomisation. Specifically, a folded piece of paper labelled as either ‘treatment’ or ‘waitlist’ is drawn out of an opaque container by a staff member not directly involved in the project.
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
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3161 0
3101
Recruitment postcode(s) [2] 3162 0
3106
Recruitment postcode(s) [3] 3163 0
3107
Recruitment postcode(s) [4] 3164 0
3108
Recruitment postcode(s) [5] 3165 0
3109
Recruitment postcode(s) [6] 3166 0
3111
Recruitment postcode(s) [7] 3167 0
3123
Recruitment postcode(s) [8] 3168 0
3124
Recruitment postcode(s) [9] 3169 0
3125
Recruitment postcode(s) [10] 3170 0
3126
Recruitment postcode(s) [11] 3171 0
3127
Recruitment postcode(s) [12] 3172 0
3130
Recruitment postcode(s) [13] 3173 0
3133
Recruitment postcode(s) [14] 3174 0
3134
Recruitment postcode(s) [15] 3175 0
3136
Recruitment postcode(s) [16] 3176 0
3147
Recruitment postcode(s) [17] 3177 0
3149
Recruitment postcode(s) [18] 3178 0
3150
Recruitment postcode(s) [19] 3179 0
3152
Recruitment postcode(s) [20] 3180 0
3153
Recruitment postcode(s) [21] 3181 0
3163
Recruitment postcode(s) [22] 3182 0
3165
Recruitment postcode(s) [23] 3183 0
3166
Recruitment postcode(s) [24] 3184 0
3168
Recruitment postcode(s) [25] 3185 0
3174
Recruitment postcode(s) [26] 3186 0
3175
Recruitment postcode(s) [27] 3187 0
3177
Recruitment postcode(s) [28] 3188 0
3181
Recruitment postcode(s) [29] 3189 0
3186
Recruitment postcode(s) [30] 3190 0
3187
Recruitment postcode(s) [31] 3191 0
3191
Recruitment postcode(s) [32] 3192 0
3196
Recruitment postcode(s) [33] 3193 0
3206
Recruitment postcode(s) [34] 3194 0
3803
Recruitment postcode(s) [35] 3195 0
3804
Recruitment postcode(s) [36] 3196 0
3805
Recruitment postcode(s) [37] 3197 0
3806
Recruitment postcode(s) [38] 3198 0
3137
Recruitment postcode(s) [39] 3199 0
3154
Recruitment postcode(s) [40] 3200 0
3155
Recruitment postcode(s) [41] 3201 0
3156
Recruitment postcode(s) [42] 3202 0
3765

Funding & Sponsors
Funding source category [1] 257561 0
Charities/Societies/Foundations
Name [1] 257561 0
J.O. & J.R. Wicking Trust
Country [1] 257561 0
Australia
Primary sponsor type
University
Name
Aged Mental Health Research Unit, School of Psychology and Psychiatry, Monash University
Address
Kingston Centre,
Warrigal Rd,
Cheltenham VIC 3192
Country
Australia
Secondary sponsor category [1] 256784 0
None
Name [1] 256784 0
Address [1] 256784 0
Country [1] 256784 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31587 0
Address 31587 0
Country 31587 0
Phone 31587 0
Fax 31587 0
Email 31587 0
Contact person for public queries
Name 14834 0
Renee Kharsas
Address 14834 0
Aged Mental Health Research Unit,
Kingston Centre,
Warrigal Rd,
Cheltenham, VIC 3192
Country 14834 0
Australia
Phone 14834 0
+61 3 9265 1705
Fax 14834 0
+61 3 9265 1711
Email 14834 0
renee.kharsas@monash.edu
Contact person for scientific queries
Name 5762 0
Renee Kharsas
Address 5762 0
Aged Mental Health Research Unit,
Kingston Centre,
Warrigal Rd,
Cheltenham, VIC 3192
Country 5762 0
Australia
Phone 5762 0
+61 3 9265 1705
Fax 5762 0
+61 3 9265 1711
Email 5762 0
renee.kharsas@monash.edu

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.