Westerhof-Evers et al. (2017)

Netherlands

RCT

PEDro=7

N_Initial=61

N_Final=56

Population: TBI; Mean Age=43.2 yr; Gender: Male=83, Female=17; Severity: Moderate to severe.

Treatment: Participants were randomly assigned to receive Treatment for Impairments in Social Cognition and Emotion Regulation (T-ScEmo, n=30) protocol or Cogniplus (n=29) training. The TScEmo protocol is aimed at enhancing emotion perception, perspective taking, theory of mind, goal-directed social behaviour through 20 individual treatment sessions offered 1-2x/wk by neuropsychologists. Cogniplus is an individually administered computerized attention training aimed at improving general cognition. Outcomes were assessed baseline (T0), post-intervention (T1), and 3-5 mo follow-up (T2).

Outcome Measure: The Awareness of Social Inferences Test (TASIT-short), Sixty faces test (FEEST), Cartoon test, Faux Pas test (FP), Wechsler Adult Intelligence Scale (WAIS-III digit span), Trail Making Test (TMT A and B/A), Test of Everyday Attention Lottery (TEA lottery), Dysexecutive Questionnaire-Social scales (DEX-Soc-self, DEX-Soc-proxy), Brock’s Adaptive Functioning Questionnaire-Social monitoring scale (BAFQ-SM-self, BAFQ-SM-proxy), BAFQ empathy scale (BAFQ-Emp-self, BAFQ-Emp-proxy), Role Resumption List (RRL), Quality of Life after Brain Injury (QOLIBRI satisfaction, QOLIBRI burden), Treatment Goal Attainment (TGA), Relationship Quality Scale (RQS-self, RQS-life partner).

1.       For the primary outcome of TASIT-short, there was no significant improvements over time in either group or no significant differences between groups.

2.       Significant Time x Group interactions from T0 to T1 were observed for FEEST (p=0.01), CT (p=0.02), RRL (p<0.01), and TGA (p<0.01). No significant interactions from T0 to T1 were observed for FP, DEX-Soc-self, DEX-Soc-proxy, BAFQ-SM-self, BAFQ-SM-proxy, BAFQ-Emp-self, BAFQ-Emp-proxy, QOLIBRI satisfaction, QOLIBRI burden, RQS-self, RQS-life partner, WAIS-III digit span, TMT A, TMT B/A, or TEA lottery.

3.       Significant Time x Group interactions from T0 to T2 were observed for FEEST (p<0.01), CT (p=0.02), BAFQ-Emp-proxy (p=0.02), RRL (p<0.01), QOLIBRI burden (p=0.04), RQS-life partner (p=0.02), and TGA (p<0.01). No significant interactions from T0 to T2 were observed for FP, DEX-Soc-self, DEX-Soc-proxy, BAFQ-SM-self, BAFQ-SM-proxy, BAFQ-Emp-self, QOLIBRI satisfaction, RQS-self, WAIS-III digit span, TMT A, TMT B/A, or TEA lottery.

Dahlberg et al. (2007)

USA

RCT

PEDro=6

N=52

Population: TBI; Mean Age=41.17 yr; Gender: Male=44, Female=8; Mean Time Post Injury=9.67 yr; Severity: Severe=40, Moderate to mild=12.

Treatment: Patients were randomly assigned to either the experimental (n=26) group or the control group (n=26). Individuals receiving the training focused on listening to others, communicating needs, and regulating their emotions during social interactions. There were 12 sessions each lasting 1.5 hr. The control group waited 3 mo before undergoing treatment. Patients were assessed 5 times: baseline (wk 0), end of treatment (wk 12), at wk 24, 36 and 48.

Outcome Measure: Profile of Functional Impairment in Communication (PFIC), Social Communication Skills Questionnaire-Adapted (SCSQ-A), Goal Attainment Scale (GAS).

1.       Results of the PFIC rating scale showed significantly greater improvements on 7 of the subscales included on the PFIC: general participation (p=0.001), quantity (p=0.024), internal relation (p=0.009), external relation (p=0.005), clarity of experience (p=0.024), social style (p<0.001) and aesthetics (p=0.014).

2.       The SCSQ-A showed significant improvement (p=0.005) for the treatment group compared to the control, pre- and post-intervention.

3.       Over time significant improvement were noted between baseline scores and post-treatment scores for all participants receiving training on the PFIC (21 of the 30 subscales: p<0.001). Significant improvement was noted on the SCSQ-A (p<0.001) as well.

4.       Significant improvements were made on the GAS from baseline to all post-treatment evaluations (p<0.001).

Bosco et al. (2018)

Italy

Pre-post

N=19

Population: Severe TBI: Mean age=38.5yr; Gender: Male=16, Female=3; Mean time post-injury=99.4 months; GCS<8.

Intervention: Groups of 5-6 participants met twice a week for 12 weeks for a total of 24 Cognitive Pragmatic Treatment (CPT) sessions. Participants were assessed at four time points, 3-months pretreatment, immediately before treatment, immediately following treatment, and 3-months post-treatment.

Outcomes: Assessment Battery for Communication (ABaCo), Communications Activities of Daily Living (CADL), Aachener Aphasie test, Attentional Matrices, Trail Making test, Verbal Span, Corsi’s Block-Tapping test, immediate and deferred recall test, Tower of London test, Modified Card Sorting test, Raven Colored Progressive Matrices, Sally & Ann, Strange Stories.

1.       There was a significant difference in scores on the ABaCO between pretreatment and posttreatment scores (p<0.001). There were no significant differences between the two initial time points or the two posttreatment timepoints.

2.       Similar results were seen for the CADL, with individuals showing a significant improvement in their functional communication skills following treatment (p=0.024).

3.       Between immediate pretreatment scores and immediate posttreatment scores significant differences were only seen on the Verbal Span (p=0.045), and the Modified Card Sorting test (p=0.004).

Finch et al. (2017)

Australia

Pre-Post

N=8

Population: TBI; Mean Age=36.25 yr; Gender: Male=4, Female=4; Mean Time Post Injury=24.6 mo; Mean GCS=8.25; Severity: moderate=1, severe=7.

Treatment: Participants received one 1 hr group and one 1 hr individual therapy session per wk for 8 wk. Therapy sessions were led by a speech-language pathologist and focussed on remediating impaired social communication skills using metacognitive strategy instruction training and goal-based therapy. Outcomes were assessed at baseline (4 wk baseline prior to intervention, pre-intervention, post-intervention, and 4 wk follow-up.

Outcome Measure: Profile of Pragmatic Impairment in Communication (PPIC), LaTrobe Communication Questionnaire (LCQ), Goal Attainment Scaling (GAS).

1.       For PPIC, only the literal content (p=0.005), general participation (p=0.02), internal relation (p=0.008), clarity of expression (p=0.026), and aesthetics (p=0.016) subscales showed significant improvement from baseline to 4 wk follow-up. No significant differences were observed for the quantity, quality, external relation, social style, or subject style subscores.

2.       For PPIC, only the aesthetics subscale was significantly improved (p=0.039) comparing post-intervention to pre-intervention.

3.       No significant differences for LCQ were observed when comparing baseline to 4 wk follow-up or pre- to post-intervention.

4.       During the intervention, participants identified between three and six goals each. Following the intervention, there was a significant increase in GAS goal T-scores (p=0.012).

Llorens et al. (2012)

Spain

Pre-Post

N=10

Population: ABI=10; Mean Age=41.1yr; Gender: Male=7, Female=3; Mean Time Post Injury=402.2d.

Intervention: Participants underwent sessions (1hr/wk for 8mo) using an interactive touch screen-based game asking questions related to knowledge, reasoning, action, and cohesion in groups of ≤4. Testing of participants occurred at baseline and post intervention.

Outcome Measure: Self-Awareness Deficits Interview (SADI), Social Skills Scale (SSS).

1.       On the SADI, after treatment all participants perceived their deficits properly compared to only 4 participants at baseline; 2 participants had difficulty perceiving their disability post treatment compared to 7 participants at baseline and 5 participants had difficulty establishing realistic goals post treatment compared to 7 at baseline.

2.       On the SSS at baseline, 6 participants showed altered levels in social skills, compared to 2 following treatment.

Braden et al. (2010)

UK

Cohort

N_initial=30

N_final=17

Population: TBI; Mean Age=42.11 yr; Gender: Male=21, Female=9; Mean Time Post Injury=7.85 yr.

Treatment: Participants received Group Interactive Structured Treatment (GIST) for social competence. This program was provided in a rehabilitation facility or in the community. A treatment workbook, developed specifically for GIST, was given to each participant. Each group member was asked to attend 13, 1.5 hr/wk sessions to discuss various topics related to effective communication. Patients were assessed at baseline, post-treatment, and at 3 and 6 mo.

Outcome Measure: Profile of Pragmatic Impairment in Communication (PPIC), Social Communication Skills Questionnaire-Adapted (SCSQ-A), Goal Attainment Scale (GAS), Satisfaction with Life Scale (SWLS).

1.       Social communication skills, as assessed by SCSQ-A, GAS and SWLS, improved significantly pre- to post-assessment (p<0.05).

2.       For those in the TBI+ group (those with a substance disorder, a psychiatric disorder, or other neurological complications) significant improvement was noted on their SCSQ-A, GAS, SWLS scores (p<0.01, p<0.000 and p=0.01 respectively).  The improvement on the PPIC was not significant (p=0.40).

3.       There were no significant differences comparing the groups (TBI only to TBI+) at baseline, post-intervention or 6 mo post-intervention for the PPIC, person ratings on SCSQ-A, GAS and SWLS.