‘SIFT’ that social information! Feasibility of a novel social cognition treatment for people with acquired brain injury

• Register: ANZCTR
• Last refreshed on: 22 July 2019
• Main ID: ACTRN12617000405314
• Date of registration: 20/03/2017
• Prospective Registration: Yes
• Primary sponsor: University of New South Wales
• 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
• Date of first enrolment: 20/06/2017
• Target sample size: 28
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000405314.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Anneli Cassel

• Name: Dr Anneli Cassel

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Acquired brain injury;Social cognitive difficulties;
Acquired brain injury
Social cognitive difficulties

Mental Health - Other mental health disorders

Neurological - Other neurological disorders

Injuries and Accidents - Other injuries and accidents

Intervention(s)

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 t

Primary Outcome(s)

Mean scores on The Awareness of Social Inference Test - Short (TASIT-S)[Baseline, Immediately post-intervention, 3 month follow-up]

Mean scores on the Hinting Task[Baseline, Immediately post-intervention, 3 month follow-up]

Mean scores on the Virtual Assessment of Mentalising Ability (VAMA)[Baseline, immediately post-intervention, 3 month follow-up]

Secondary Outcome(s)

Mean scores on the Social Problem Fluency Test[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Frontal Systems Behaviour Scale (FrSBe)[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Balanced Emotional Empathy Scale (BEES)[Baseline, immediately post-intervention, 3 month follow-up]

Implementation of trial protocol and intervention: completion of data collection, number of participants lost to follow-up, fidelity of therapy program delivery[Throughout]

Mean scores on the 20 Item Toronto Alexithymia Scale (TAS-20)[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Quality of Life after Brain Injury - Overall Scale (QOLIBRI)[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Questionnaire of Cognitive and Affective Empathy (QCAE)[Baseline, immediately post-intervention, 3 month follow-up]

Acceptability of intervention: rate of therapy attendance, mean satisfaction ratings on a 10-point Likert scale, semi-structured interviews[Throughout, immediately post-intervention]

Mean scores on the Observable Social Cognition - A Rating Scale (OSCARS)[Baseline, immediately post-intervention, 3 month follow-up]

Demand for treatment: recruitment rate, consent rate, eligibility rate[Throughout]

Mean scores on the Social Skills Questionnaire for Traumatic Brain Injury (SSQ-TBI)[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Awareness Questionnaire (AQ)[Baseline, immediately post-intervention, 3 month follow-up]

Mean scores on the Social Phobia Inventory (SPIN)[Baseline, immediately post-intervention, 3 month follow-up]

Secondary ID(s)

None

Source(s) of Monetary Support

University of New South Wales

Ethics review

Status: Approved
Approval date:
Contact:

Royal Rehab Research Governance Ethics Committee

Status: Approved
Approval date:
Contact:

Sydney Local Health District (SLHD) Ethics Review Committee (RPAH Zone)

Results

• Results available: Yes
• Date Posted: 10/07/2019
• Date Completed: 04/07/2019