Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001167752
Ethics application status
Approved
Date submitted
17/10/2013
Date registered
23/10/2013
Date last updated
29/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Positive Psychology Intervention to Reduce Suicidal Thoughts and Behaviour
Scientific title
A randomised controlled trial evaluating a positive psychology intervention in reducing the severity and intensity of suicidal thoughts and behaviour in individuals presenting to emergency department with suicidal thoughts or behaviour
Secondary ID [1] 283184 0
Nil
Universal Trial Number (UTN)
U1111-1147-8172
Trial acronym
PPSB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 290042 0
Suicide attempt 290342 0
Suicide planning 290343 0
Condition category
Condition code
Mental Health 290421 290421 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.
Intervention code [1] 287909 0
Prevention
Intervention code [2] 287910 0
Treatment: Other
Intervention code [3] 287911 0
Behaviour
Comparator / control treatment
Standard care (treatment as usual) following presentation for suicidal behaviour varies and may involve receiving a psychiatric intervention (crisis stabilisation within an inpatient setting that may involve a combination of medication and psychotherapy), psychological intervention (e.g. cognitive behaviour therapy within an outpatient setting), treatment for alcohol or drug abuse, counselling, anger management, or GP follow-up care. The type of care received is determined by the medical and mental health professionals in the emergency department.
Control group
Active

Outcomes
Primary outcome [1] 290447 0
Change in suicidal ideation severity and intensity on the Columbia Suicide Severity Rating Scale (scores on the severity scale range from 0-5 with higher scores indicating greater severity, while scores on the intensity scale range from 0-25 with higher scores indicating greater intensity).
Timepoint [1] 290447 0
[Time Frame: end of treatment period]
[Time Frame: end of the follow-up period (2 months after treatment is complete)]

Secondary outcome [1] 304530 0
Change in depression score on the Major Depression Inventory (scores range from 0-50 with higher scores indicating greater severity).
Timepoint [1] 304530 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [2] 304531 0
Change in anxiety score on the Generalised Anxiety Disorder Scale (scores range from 0-21 with higher scores indicating greater anxiety)
Timepoint [2] 304531 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [3] 304532 0
Change in substance use over the last two weeks as measured by the Alcohol and Drug Use Outcome measure
Timepoint [3] 304532 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [4] 304533 0
Change in suicidal ideation score on the Columbia Suicide Severity Rating Scale (C-SSRS) Part A (Scores range from 0-5 with higher scores indicating greater severity).
Timepoint [4] 304533 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [5] 304534 0
Change in scores on the PERMA-P Questionnaire (5 constructs; positive emotion, engagement, positive relationships, meaning, and accomplishment. Scores for each construct range from 0-10 with higher scores indicating greater wellbeing). There is also a general wellbeing score that ranges from 0-10 with a higher score indicating greater wellbeing.
Timepoint [5] 304534 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [6] 304535 0
Change in positive and negative emotions score on the Positive and Negative Affect Scale (2 sub-scales; one positive affect (PA) and one negative affect (NA). Scores range from 10 to 50 for each sub-scale, with higher scores indicating greater levels of PA or NA.
Timepoint [6] 304535 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [7] 304536 0
Change in reasons for living sub-scale scores (6 sub-scales, 12 items, 2 per sub-scale: survival and coping beliefs, responsibility to family, child-related concerns, fear of suicide, fear of social disapproval, and moral objections). Scores range from 1-6 for each sub-scale, calculated by finding the mean score from the set of items for each sub-scale. Higher scores indicate the more important a particular reason is for living.
Timepoint [7] 304536 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [8] 304733 0
Change in coping self efficay sub-scale scores and overall score (3 sub-scales: problem-focused coping (12 items), emotion-focused coping (9 items), and social support (5 items). Total score is the summed sub-scale scores. Total scores range from 0-260 with a higher score indicating that a person is more confident on their ability to cope.
Timepoint [8] 304733 0
[Time Frame: Change from baseline at 2 weeks after treatment is complete (primary)]
[Time Frame: Change from baseline at end of follow-up period (2 months after treatment is complete)]
Secondary outcome [9] 308012 0
Re-presentations to the emergency department for suicidal behaviour (e.g., suicidal ideation, suicide planning, suicide attempt) by checking patient health records and the use of questionnaires.
Timepoint [9] 308012 0
[Time Frame: end of treatment period] [Time Frame: end of the follow-up period (2 months after treatment is complete)]

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) Unwilling to be randomised or followed up per study protocol; 9) Currently in prison; 10) Will be living outside of Christchurch for the follow-up period; 11) Unable to provide two contact phone numbers.

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)
Potential participants will be enrolled in the study in the week following their discharge (over the phone) and then randomised to receive either the intervention or treatment as usual. The randomisation process will be concealed by having a research associate carry out the randomisation process. An allocation schedule will be used to prepare a set of opaque consecutively numbered sealed envelopes, with the treatment group (intervention/control) indicated inside the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by using a computer-generated randomisation procedure generator (http://www.randomization.com) to generate an allocation schedule.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of this study is based on the expected effect on the primary outcome measure, i.e. the reduction in severity and intensity of suicidal thoughts. In order to be able to demonstrate an effect size of 0.45 (Cohen’s d; Cohen, 1988) with a = 0.05 and beta = 0.20 (Power = 80%), 80 subjects are needed in each condition (Dupont and Plummer, 1990). When including an expected drop-out of 15%, the total sample size is determined at 190 at a 1:1 ratio. Statistical analysis of pre and post-intervention data will be performed using IBM SPSS statistical software (version 19.0). A demographic comparison will be made between the intervention and control groups at baseline; using an independent samples t-tests for continuous variables and chi-square tests for categorical variables. Further suicidal behaviour: counts and means will be calculated for each of the two experimental groups. A t-test will be used to compare the means of the two groups. Change in scale scores: counts and means will be calculated for each of the two experimental groups at each assessment point (baseline, 12 weeks and 26 months). T-tests will be used to compare the means of the two groups.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
18/08/2014
Actual
Date of last participant enrolment
Anticipated
9/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment outside Australia
Country [1] 5430 0
New Zealand
State/province [1] 5430 0
Canterbury

Funding & Sponsors
Funding source category [1] 288001 0
University
Name [1] 288001 0
University of Canterbury
Country [1] 288001 0
New Zealand
Primary sponsor type
Individual
Name
Kosta Tabakakis (PhD Candidate)
Address
Department of Psychology
University of Canterbury
Private Bag 4800,
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286723 0
Individual
Name [1] 286723 0
Associate Professor Janet Carter
Address [1] 286723 0
Department of Psychology
University of Canterbury
Private Bag 4800,
Christchurch 8140
New Zealand
Country [1] 286723 0
New Zealand
Other collaborator category [1] 277629 0
Individual
Name [1] 277629 0
Professor David Fergusson
Address [1] 277629 0
Christchurch Health and Development Study
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [1] 277629 0
New Zealand
Other collaborator category [2] 277630 0
Individual
Name [2] 277630 0
Professor Annette Beautrais
Address [2] 277630 0
34 Rayburn Avenue
Papanui
Christchurch 8053
New Zealand
Country [2] 277630 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289926 0
University of Canterbury Human Ethics Committee
Ethics committee address [1] 289926 0
Human Ethics Committee
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Ethics committee country [1] 289926 0
New Zealand
Date submitted for ethics approval [1] 289926 0
07/10/2013
Approval date [1] 289926 0
27/01/2014
Ethics approval number [1] 289926 0
HEC 2013/147
Ethics committee name [2] 289929 0
Health and Disability Ethics Committee
Ethics committee address [2] 289929 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [2] 289929 0
New Zealand
Date submitted for ethics approval [2] 289929 0
07/10/2013
Approval date [2] 289929 0
21/01/2014
Ethics approval number [2] 289929 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 activities to perform over 8 weeks reduces the severity and intensity of their suicidal ideation when compared to a group receiving treatment as usual. We believe that the group receiving treatment as usual plus the handbook with activities to perform will have lower mean suicidal ideation severity and intensity scores than the group receiving treatment as usual alone.
Trial website
Trial related presentations / publications
Public notes
Given the poor results from the feasibility and acceptability study, a randomised controlled trial is not warranted.

Contacts
Principal investigator
Name 42814 0
Mr Kosta Tabakakis
Address 42814 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 42814 0
New Zealand
Phone 42814 0
+64 22 151 3002
Fax 42814 0
Email 42814 0
[email protected]
Contact person for public queries
Name 42815 0
Mr Kosta Tabakakis
Address 42815 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 42815 0
New Zealand
Phone 42815 0
+64 22 151 3002
Fax 42815 0
Email 42815 0
[email protected]
Contact person for scientific queries
Name 42816 0
Mr Kosta Tabakakis
Address 42816 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 42816 0
New Zealand
Phone 42816 0
+64 22 151 3002
Fax 42816 0
Email 42816 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.