Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000454673
Ethics application status
Approved
Date submitted
17/04/2014
Date registered
1/05/2014
Date last updated
29/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Positive Psychology Intervention for Suicidal Thoughts and Behaviour - Feasibility and Acceptability Study.
Scientific title
A feasibility study evaluating the acceptability of providing a positive psychology intervention to individuals presenting to the emergency department with suicidal thoughts or behaviour.
Secondary ID [1] 284449 0
Nil
Universal Trial Number (UTN)
U1111-1155-7803
Trial acronym
PPSTB-FAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 291672 0
Suicide attempt 291673 0
Condition category
Condition code
Mental Health 292051 292051 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION
The positive psychology intervention will involve the serial completion of activities (known as positive activities) over a period of eight weeks; one activity per week. The positive activities to be performed are: Week 1 - "What Went Well"?; Week 2: Gratitude Letter; Week 3 - Acts of Kindness; Week 4 - Best Possible Future Self; Week 5 - Nurturing Social Relationships; Week 6 - Get Active; Week 7- Committing to Your Goals; and Week 8 - Increasing 'Flow' Experiences. The activities take approximately 20-30 minutes to complete and only needed to be completed once during the week. Adherence will be monitored through bi-weekly phone calls to the participant to check activity completion. Participants will also be required to keep a diary recording activity completion. This will be collected by the study investigators at the end of the intervention phase. Activities will be administered using a handbook (hard copy or electronic PDF).
Intervention code [1] 289202 0
Treatment: Other
Intervention code [2] 289203 0
Prevention
Intervention code [3] 289279 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291927 0
Acceptability - Number and percentage of participants initially enrolled who go on to complete the entire 8-week intervention.
Timepoint [1] 291927 0
[Time Frame: End of the intervention period]
Secondary outcome [1] 307851 0
Participation Rate - The number and percentage of individuals who consent to participating in the study as a total of the number of presenters to the emergency department who meet eligibility criteria and are invited to participate in the study.
Timepoint [1] 307851 0
[Time Frame: End of the intervention period]
Secondary outcome [2] 307852 0
Logicalness and Credibility/Expectancy Scores - participant ratings on logicalness, usefulness, success of intervention, and how confident the participant would be in recommending intervention to others. A series of four 9-point scales will be used to assess these variables higher points on the scale indicating greater logicalness, usefulness, expectations of success, more likely to recommend to others.
Timepoint [2] 307852 0
[Time Frame: End of 8 week intervention period]
Secondary outcome [3] 307853 0
Activity Completion - Number of activities completed during the intervention period. This will be recorded by the participant either in a hard copy diary or an online questionnaire.
Timepoint [3] 307853 0
[Time Frame: End of the 8 week intervention period]

Eligibility
Key inclusion criteria
Individuals who present to the CHCH ED: 1) 16 years or older; 2) With a presenting complaint which includes suicidal ideation or plan for suicide, or who have made a suicide attempt; 3) Have the physical and cognitive capacity to meet the requirements of the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to read or understand English; 2) Current psychotic disorder; 3) Current homicide risk; 4) Life-threatening medical condition requiring hospitalisation; 5) Admitted to a psychiatric inpatient unit; 6) Lack capacity to give informed consent; 7) Leave the ED against medical advice or without being seen; 8) Currently in prison; 9) Will be living outside of Christchurch for the follow-up period; 10) Unable to follow-up.

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)
Potential participants will be enrolled in the study in the week following their discharge (over the phone) and will be given the intervention as an adjunct to standard care.
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
Statistical analysis of pre and post-intervention data will be performed using IBM SPSS statistical software (version 19.0).

A demographic profile will be provided.

Proportions and percentages will be calculated for the primary and secondary outcomes.

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
2/05/2014
Actual
6/05/2014
Date of last participant enrolment
Anticipated
Actual
4/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 6014 0
New Zealand
State/province [1] 6014 0
Canterbury

Funding & Sponsors
Funding source category [1] 289106 0
University
Name [1] 289106 0
University of Canterbury
Country [1] 289106 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Department of Psychology
University of Canterbury
Private Bag 4800,
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287772 0
None
Name [1] 287772 0
Address [1] 287772 0
Country [1] 287772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290892 0
University of Canterbury Human Ethics Committee
Ethics committee address [1] 290892 0
Private Bag 4800,
Christchurch 8140
New Zealand
Ethics committee country [1] 290892 0
New Zealand
Date submitted for ethics approval [1] 290892 0
Approval date [1] 290892 0
27/02/2014
Ethics approval number [1] 290892 0
HEC 2013/147
Ethics committee name [2] 290893 0
Health and Disability Ethics Committee
Ethics committee address [2] 290893 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [2] 290893 0
New Zealand
Date submitted for ethics approval [2] 290893 0
Approval date [2] 290893 0
14/02/2014
Ethics approval number [2] 290893 0
13/NTB/163

Summary
Brief summary
The primary purpose of the study is to determine if providing a group of individuals who present to the emergency department with suicidal behaviour with a handbook containing a set of positive psychology activities to perform over 8 weeks is feasible and well-accepted.
Trial website
Trial related presentations / publications
Public notes
20/08/2014

Due to a high refusal and withdrawal rate it has been decided to discontinue the current feasibility and acceptability study. If you have any questions or queries, please do not hesitate to contact the study coordinator.

Contacts
Principal investigator
Name 47774 0
Mr Kosta Tabakakis
Address 47774 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 47774 0
New Zealand
Phone 47774 0
+64 22 151 3002
Fax 47774 0
Email 47774 0
[email protected]
Contact person for public queries
Name 47775 0
Mr Kosta Tabakakis
Address 47775 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 47775 0
New Zealand
Phone 47775 0
+64 22 151 3002
Fax 47775 0
Email 47775 0
[email protected]
Contact person for scientific queries
Name 47776 0
Mr Kosta Tabakakis
Address 47776 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 47776 0
New Zealand
Phone 47776 0
+64 22 151 3002
Fax 47776 0
Email 47776 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.