Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000405314
Ethics application status
Approved
Date submitted
16/03/2017
Date registered
20/03/2017
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Date results information initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
‘SIFT’ that social information! Feasibility of a novel social cognition treatment for people with acquired brain injury
Scientific title
‘SIFT’ that social information! Feasibility of a novel social cognition treatment for people with acquired brain injury
Secondary ID [1] 291355 0
None
Universal Trial Number (UTN)
U1111-1193-7871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 302383 0
Social cognitive difficulties 302384 0
Condition category
Condition code
Injuries and Accidents 301964 301964 0 0
Other injuries and accidents
Neurological 302075 302075 0 0
Other neurological disorders
Mental Health 302076 302076 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: SIFT IT! The Social Thinking Therapy
SIFT IT is a group treatment with up to four participants per group delivered in face-to-face sessions. It uses transdiagnostic CBT techniques (guided discovery, Socratic questioning, generating alternative beliefs, testing alternative beliefs in different responses) to support participants to understand self- and other- thought-feeling-behaviour cycles involved in each of the ‘SIFT IT’ social cognitive processes. It also applies principles of cognitive remediation, i.e. repetition, practice, and building on single processes to culminate in complex interactions.

Each group session involves an Introduction & agenda setting, Previous session review, Check in with participants, Homework review, Current topic for today’s session, Homework setting, and Take home messages. Session content involves group discussions, whiteboard activities, interactive games and activities using pictures, videos, ‘playing cards’ of social situations, and personalised role play. Homework consists of worksheets continuing the topic of the session: they aim to support the participant to relate the concepts discussed in the session to their own life examples (e.g. practice generating alternative ínterpretations to situations encountered using different 'filters') and may involve an 'experiment' to trial the techniques used in the session. Completing these worksheets may take up to 30 minutes per week.

The treatment comprises 14 sessions, delivered once a week in 90 to 120 minute sessions (including a break). The first group session introduces participants to SIFT IT; Phase I (approx. Sessions 2-6) cover psychoeducation of processes important in social cognition (Sensing, Interpreting… Feelings, Thoughts, Intentions); in Phase II (approx. Sessions 7-10) the interrelations between processes are highlighted using participants real life experiences to improve perspective taking; Phase III (approx. Sessions 11-13) support participants to choose adaptive ways to ‘try’ out their response to reach their goals; and Session 14 will review topics covered throughout the treatment.

An AHPRA registered Clinical Psychologist will deliver the intervention with experience working with people with brain injury. The location of the group sessions will depend on participant needs and location of participant recruitment. They will all occur in a large room suitable for group therapy, in either academic or clinical service locations.

As each participant will develop individualised goals of what they would like to achieve through participation and they will be encouraged to bring personal examples to discuss in the group and relate to key concepts discussed, each group will be personalised to the particular participants attending. Even so, each group will follow the core processes described above.

Adherence will be assessed by monitoring attendance to group sessions; attempts to complete homework. Fidelity will be assessed by random selection of 10% of completed group sessions in which a trained member of the research team will rate the facilitator on SIFT IT Fidelity Scale (Agenda setting, Previous session review, Check-in, Homework, Adherence to session content, Quality of delivery, Session homework, Take-home messages).
Intervention code [1] 297500 0
Treatment: Other
Intervention code [2] 297501 0
Rehabilitation
Intervention code [3] 297502 0
Behaviour
Comparator / control treatment
Waitlist control: participants in this group will receive no intervention between the baseline assessment (Time 1) and the post-treatment assessment (Time 2), which will take place after the 'treatment' group has completed the 14-week therapy. The waitlist control group will be offered treatment following the Time 2 assessment.
Control group
Active

Outcomes
Primary outcome [1] 301469 0
Mean scores on The Awareness of Social Inference Test - Short (TASIT-S)
Timepoint [1] 301469 0
Baseline, Immediately post-intervention, 3 month follow-up
Primary outcome [2] 301470 0
Mean scores on the Virtual Assessment of Mentalising Ability (VAMA)
Timepoint [2] 301470 0
Baseline, immediately post-intervention, 3 month follow-up
Primary outcome [3] 301471 0
Mean scores on the Hinting Task
Timepoint [3] 301471 0
Baseline, Immediately post-intervention, 3 month follow-up
Secondary outcome [1] 332762 0
Mean scores on the Social Problem Fluency Test
Timepoint [1] 332762 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [2] 332763 0
Mean scores on the Observable Social Cognition - A Rating Scale (OSCARS)
Timepoint [2] 332763 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [3] 332764 0
Mean scores on the Balanced Emotional Empathy Scale (BEES)
Timepoint [3] 332764 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [4] 332766 0
Mean scores on the Questionnaire of Cognitive and Affective Empathy (QCAE)
Timepoint [4] 332766 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [5] 332767 0
Mean scores on the 20 Item Toronto Alexithymia Scale (TAS-20)
Timepoint [5] 332767 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [6] 332768 0
Mean scores on the Social Phobia Inventory (SPIN)
Timepoint [6] 332768 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [7] 332769 0
Mean scores on the Awareness Questionnaire (AQ)
Timepoint [7] 332769 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [8] 332770 0
Mean scores on the Frontal Systems Behaviour Scale (FrSBe)
Timepoint [8] 332770 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [9] 332771 0
Mean scores on the Social Skills Questionnaire for Traumatic Brain Injury (SSQ-TBI)
Timepoint [9] 332771 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [10] 332772 0
Mean scores on the Quality of Life after Brain Injury - Overall Scale (QOLIBRI)
Timepoint [10] 332772 0
Baseline, immediately post-intervention, 3 month follow-up
Secondary outcome [11] 332774 0
Demand for treatment: recruitment rate, consent rate, eligibility rate
Timepoint [11] 332774 0
Throughout
Secondary outcome [12] 332776 0
Implementation of trial protocol and intervention: completion of data collection, number of participants lost to follow-up, fidelity of therapy program delivery
Timepoint [12] 332776 0
Throughout
Secondary outcome [13] 332777 0
Acceptability of intervention: rate of therapy attendance, mean satisfaction ratings on a 10-point Likert scale, semi-structured interviews
Timepoint [13] 332777 0
Throughout, immediately post-intervention

Eligibility
Key inclusion criteria
(1) experienced a moderate to severe acquired brain injury (for traumatic brain injury: score on the Glasgow Coma Scale of 9-12 [moderate], 8 or less [severe] and/or a period of post traumatic amnesia of 1-24 hours [moderate], more than 24 hours [severe])
(2) at least six months post-injury
(3) residing in the community for at least six months
(4) between 18 and 65 years of age
(5) sufficient cognitive capabilities to participate in assessment and group tasks
(6) sufficient English language proficiency to participate in assessment and group tasks
(7) performance at least one standard deviation below normative sample on social cognition measures at baseline assessment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) diagnosed developmental delay
(2) substantive expressive and/or receptive language impairment
(3) recent history or current risk of major psychiatric crisis (e.g. suicide attempt, psychotic relapse)
(4) uncorrected visual or hearing impairment

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)
Concealed allocation: Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation, generated following recruitment of up to 8 eligible participants (to randomly allocate 4 into each group)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimations were not conducted due to this research being in its pilot phase. It is recommended for pilot clinical feasibility trials to have a completed sample size of at least 24 participants. To account for an estimated 14% attrition rate (based on mean attrition rates reported in similar treatment trials conducted within the Sydney region), a total sample size of 28 will therefore be the aim for recruitment.

Data will be analysed using a mixed methods approach. Quantitative feasibility data will be analysed by examining treatment effects (interaction analyses) and individual reliable change indices. Qualitative feasibility data will be analysed using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2017
Actual
20/06/2017
Date of last participant enrolment
Anticipated
Actual
28/09/2018
Date of last data collection
Anticipated
Actual
4/07/2019
Sample size
Target
28
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7676 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [2] 11449 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 11450 0
Hunter Brain Injury Service - Bar Beach
Recruitment postcode(s) [1] 15594 0
2112 - Ryde
Recruitment postcode(s) [2] 23467 0
2170 - Liverpool
Recruitment postcode(s) [3] 23468 0
2300 - Bar Beach

Funding & Sponsors
Funding source category [1] 295828 0
University
Name [1] 295828 0
University of New South Wales
Country [1] 295828 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 294796 0
None
Name [1] 294796 0
Address [1] 294796 0
Country [1] 294796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297112 0
Sydney Local Health District (SLHD) Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 297112 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 297112 0
Australia
Date submitted for ethics approval [1] 297112 0
20/09/2016
Approval date [1] 297112 0
17/11/2016
Ethics approval number [1] 297112 0
HREC/16/RPAH/572
Ethics committee name [2] 297202 0
Royal Rehab Research Governance Ethics Committee
Ethics committee address [2] 297202 0
Royal Rehab
235 Morrison Road
Ryde NSW 2112
Ethics committee country [2] 297202 0
Australia
Date submitted for ethics approval [2] 297202 0
25/01/2017
Approval date [2] 297202 0
03/02/2017
Ethics approval number [2] 297202 0
SSA-AU/2/FFAA211

Summary
Brief summary
Understanding emotions, understanding that other people think or feel things differently to ourselves, and thinking and feeling from another’s perspective are all skills associated with social cognition. There are many reasons why some people find it more difficult to do these things, and having a brain injury is one of them: the regions in the brain that can be damaged through injury often affect the areas we know are important for social cognition. What is less well understood is whether it is possible to treat social cognitive deficits after such an injury.

This is because very little research has been done trialling these kinds of treatments for people with a brain injury, and there have been no trials that have ‘comprehensively’ targeted the interrelating process of social cognition. The aim of this study, therefore, is to trial a novel social cognition treatment (SIFT IT), a therapy that has been developed considering the needs of those living with a brain injury, yet still informed by treatments developed in other clinical populations. SIFT IT: The Social Thinking Therapy has been designed as a group program that will run for 14 weekly sessions, each 90-120 minutes. It combines principles of cognitive behavioural therapy (CBT) with cognitive remediation to help participants understand the breadth of processes involved in social cognition and then to apply them to their everyday lives.

As SIFT IT is a new psychotherapeutic group intervention, the focus of this study is on whether it is possible to treat social cognitive deficits in this way in this population: i.e. to examine the intervention’s feasibility. Feasibility will be examined by looking at the demand for the therapy, how well the therapy can be implemented, the acceptability of the treatment, and whether it looks like the therapy is helping people improve their social cognitive skills. The study will run as a randomised controlled trial. Participants with a brain injury who have scored lower than expected on at least one social cognition assessment measure will be randomly allocated to the SIFT IT therapy group or to a waitlist control. Testing will take place after initial recruitment to gather baseline performance, then again after the SIFT IT therapy group has finished, then again after a further three months. The participants in the waitlist control will be offered to take part in the therapy group after the second round of testing. All participants will be asked to take part in a semi-structured interview after they have taken part in the therapy group to find out more detailed information about how they found the program.

Data gathered from the trial will be analysed in a mixed methods approach. Some data will provide descriptive information about the participants and feasibility outcomes. Some data will allow for examination of changes in outcomes pre- to post-intervention. Other data will be analysed for common themes from feedback to examine therapy acceptability.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1579 1579 0 0
/AnzctrAttachments/372489-HREC Approval 0754_001.pdf (Ethics approval)
Attachments [2] 1580 1580 0 0
/AnzctrAttachments/372489-17SSA03 SSA Approval letter.docx (Ethics approval)

Contacts
Principal investigator
Name 73014 0
Dr Anneli Cassel
Address 73014 0
University of New South Wales
School of Psychology
Mathews Building
Randwick
NSW 2052
Country 73014 0
Australia
Phone 73014 0
+61 2 9385 9067
Fax 73014 0
Email 73014 0
[email protected]
Contact person for public queries
Name 73015 0
Dr Anneli Cassel
Address 73015 0
University of New South Wales
School of Psychology
Mathews Building
Randwick
NSW 2052
Country 73015 0
Australia
Phone 73015 0
+61 2 9385 9067
Fax 73015 0
Email 73015 0
[email protected]
Contact person for scientific queries
Name 73016 0
Dr Anneli Cassel
Address 73016 0
University of New South Wales
School of Psychology
Mathews Building
Randwick
NSW 2052
Country 73016 0
Australia
Phone 73016 0
+61 2 9385 9067
Fax 73016 0
Email 73016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be available due to the small number of participants combined with risk of re-identification if their individual data were available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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