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Trial registered on ANZCTR


Registration number
ACTRN12615000840583
Ethics application status
Approved
Date submitted
29/07/2015
Date registered
13/08/2015
Date last updated
22/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Problem Solving Therapy with young stroke patients
Scientific title
The efficacy of problem solving therapy for treating depression in younger (18-65) stroke patients compared to a social control group
Secondary ID [1] 287172 0
Nil Known
Universal Trial Number (UTN)
U1111-1172-1539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 295737 0
Anxiety 295738 0
Stroke 295845 0
Condition category
Condition code
Mental Health 296013 296013 0 0
Depression
Mental Health 296017 296017 0 0
Anxiety
Stroke 296099 296099 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Problem Solving Treatment (PST): Participants in this group will be offered the brief psychological therapy, which will aim to teach them how to use their own skills to cope with their everyday life problems in a systematic way. The therapy comprises seven stages: (1) Explanation and rationale, (2) Clarification and definition of the problems, (3) Establishing achievable goals, (4) Generating solutions, (5) Selective preferred solution, (6) Implementing solution, (7) Evaluation of progress. The intervention will be made up of six group sessions of one hour a week. The programme will specifically target problems resulting from their stroke. Throughout the sessions the participants will receive psycho-education on post stroke depression and anxiety in general and learn specifically about the mechanics of PST and why it is effective. Therapists will guide patients to generate a list of problems that they are currently experiencing in their lives and select and clearly define a moderately challenging one to focus on. Patients will then identify a goal, related to that problem, that they would like to achieve and brainstorm strategies to meet the goal, producing as many solutions as possible. Following this, patients assess the pros and cons of each solution they have created and choose one or more to implement. They then generate an action plan containing steps by which to carry out this solution. The action plan will be reviewed and the success (or lack of success) at achieving the goal is discussed and a new solution will be developed if necessary.

The principal investigator (myself, Charlotte Wainwright, a clinical psychology trainee) will run the Problem Solving Therapy Sessions with a co facilitator (another clinical psychology trainee). The principal investigator will always have access to a registered clinical psychologist during sessions as the sessions will be run at the Massey University Psychology clinic. The principal investigator will attend supervision after each therapy session. The sessions will be run in group format of six to eight participants. A register of attendance will be taken at the beginning of each session.
Intervention code [1] 292446 0
Rehabilitation
Intervention code [2] 292524 0
Treatment: Other
Intervention code [3] 292525 0
Behaviour
Comparator / control treatment
Instead of using a social control group, it was decided that a waitlist control group would be used.
Control group
Active

Outcomes
Primary outcome [1] 295687 0
Depression, assessed by the Centre for Epidemiologic Depression Scale (CES-D)
Timepoint [1] 295687 0
Base line (prior to the beginning of the therapy sessions)
At the final therapy session (week six)
Three months following the final therapy session
Secondary outcome [1] 316228 0
Anxiety, assessed by the Hospital Anxiety and Depression Scale - Anxiety sub-scale (HADS-A)
Timepoint [1] 316228 0
Base line (prior to the beginning of the therapy sessions)
At the final therapy session (week six)
Three months following the final therapy session
Secondary outcome [2] 316230 0
Problem solving ability, assessed by the Social Problem Solving Inventory Revised: Short Form
Timepoint [2] 316230 0
Base line (prior to the beginning of the therapy sessions)
At the final therapy session (week six)
Three months following the final therapy session
Secondary outcome [3] 316231 0
Quality of life, assessed by the Stroke Specific - Quality of Life Scale (SS-QOL)
Timepoint [3] 316231 0
Base line (prior to the beginning of the therapy sessions)
At the final therapy session (week six)
Three months following the final therapy session

Eligibility
Key inclusion criteria
Inclusion criteria for participants will be a diagnosis of stroke within the previous six months to two years of the current study. Participants will be between the ages of 18 and 65 and will be able to get to and partake in therapy sessions. Participants will also be experiencing symptoms of depression and anxiety.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they suffer from severe aphasia or are unable to give informed consent and therefore can not take part in therapy sessions or complete assessment measures.

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)
Recommendations for participants who meet the inclusion criteria will be taken from the neurology team at Wellington hospital. It is intended that possible participants will be contacted and given information about this study via health professionals from Wellington hospital. They will be sent out an information pack about the research project, as well as the contact details of the researcher. In order to honour privacy and give participants time to decide on their own, an 0800 number will be set up for possible participants to phone with queries and to register interest in participation. A freepost envelope and email information will also be included in the pack for clients to respond.

Social control groups were no longer used therefore the administrators of the social support group were not contacted.

As the trial was extended to Tauranga, the Tauranga participants were placed on the waitlist. No random allocation was used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Social control groups were no longer used.

As the trial was extended to Tauranga, the Tauranga participants were placed on the waitlist. No random allocation was used. For either group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data collected will be both quantitative and qualitative in nature. Demographic variables will be analysed with an independent sample T-test for continuous variables, the Mann-Whitney U test for ordinal variables, and the chi-square test for categorical variables.
Responses on the LUNS will be analysed using descriptive statistics. These will include frequency and percentage response distributions, measures on central tendency (mean, median and mode) and dispersion measures (range and standard deviation).
With regards to the therapy groups, all cases will be analysed using data at baseline and data at T2 and T3. Differences within treatment groups will be analysed using McNemar tests and paired t-tests to assess changes over time.
The effect of the intervention will be the difference in outcome between the PST group and the wait-list control group (level of significance p<0.05). In order to investigate the effect of the intervention, univariate general linear models and binary logistic regression will be used. Gender, age and other baseline values will be used as covariates to correct for baseline differences between the groups.
Models will be created for both primary (depression) and secondary (anxiety, problem solving and quality of life) outcome variables with time, group condition (intervention or control), and the interaction between these variables as predictors. Furthermore, variables that are accidentally not equally distributed between the two group conditions will be controlled for.
All quantitative data will be analysed using SPSS version 22 for windows.
The value of the PST sessions to participants will be analysed using coding and content analysis. Descriptive statistics will be used to summarize participant’s ratings of helpfulness, enjoyment, and future use of PST.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/02/2016
Date of last participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last data collection
Anticipated
1/10/2016
Actual
Sample size
Target
56
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 7056 0
New Zealand
State/province [1] 7056 0
Wellington
Country [2] 8048 0
New Zealand
State/province [2] 8048 0
Tauranga

Funding & Sponsors
Funding source category [1] 291737 0
University
Name [1] 291737 0
Massey University Post Graduate Research Fund
Country [1] 291737 0
New Zealand
Primary sponsor type
Individual
Name
Charlotte Wainwright
Address
Massey University
Wallace Street
Mount Cook
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 290411 0
None
Name [1] 290411 0
Address [1] 290411 0
Country [1] 290411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293259 0
Health and Disablity Ethics Committees
Ethics committee address [1] 293259 0
Ethics committee country [1] 293259 0
New Zealand
Date submitted for ethics approval [1] 293259 0
17/08/2015
Approval date [1] 293259 0
09/09/2015
Ethics approval number [1] 293259 0
15/CEN/124

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

Contacts
Principal investigator
Name 59134 0
Ms Charlotte Wainwright
Address 59134 0
Massey University
Wallace Street
Mount Cook
Wellington
6021
Country 59134 0
New Zealand
Phone 59134 0
+64 27 2427568
Fax 59134 0
Email 59134 0
char.pr.wainwright@gmail.com
Contact person for public queries
Name 59135 0
Charlotte Wainwright
Address 59135 0
Massey University
Wallace Street
Mount Cook
Wellington
6021
Country 59135 0
New Zealand
Phone 59135 0
+64 27 2427568
Fax 59135 0
Email 59135 0
char.pr.wainwright@gmail.com
Contact person for scientific queries
Name 59136 0
Charlotte Wainwright
Address 59136 0
Massey University
Wallace Street
Mount Cook
Wellington
6021
Country 59136 0
New Zealand
Phone 59136 0
+64 27 2427568
Fax 59136 0
Email 59136 0
char.pr.wainwright@gmail.com

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.