Trial Outcomes & Findings for Stepped Care for Aphasia (NCT NCT05851573)

Last Updated: 2025-02-24

Results Overview

Change in the total depression Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

through intervention completion, an average of 7 weeks

Results posted on

2025-02-24

Participant Flow

Interested participants provided informed consent and were then screened to determine if they meet all eligibility criteria. After enrollment, all participants were assigned to the same intervention arm.

Participant milestones

Participant milestones
Measure	Psychosocial Intervention Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stepped Care for Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychosocial Intervention n=11 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Age, Continuous	57.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Western Aphasia Battery-Revised Aphasia Quotient	74.0 units on a scale STANDARD_DEVIATION 18.0 • n=5 Participants
Months Post-Stroke	43.6 months STANDARD_DEVIATION 41.1 • n=5 Participants
Years of Education	15.8 years STANDARD_DEVIATION 2.9 • n=5 Participants
Cognitive Assessment of Stroke Patients	30.3 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Population: One participant was excluded due to missing HADS data at post-intervention.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=10 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention	2.2 units on a scale Standard Deviation 2.82

PRIMARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Population: One participant was excluded due to missing HADS data at post-intervention.

Change in the total anxiety Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=10 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention	0.40 units on a scale Standard Deviation 4.30

SECONDARY outcome

Timeframe: through study completion, an average of 7 weeks

Total summary score (min: 0, max: 100, higher scores indicate better outcome) and sadness score (min: 0, max: 100, higher scores indicate better outcome) (baseline-post-treatment). Positive number indicate worsening in mood, negative numbers indicate an improvement in mood.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=11 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Dynamic Visual Analogue Mood Scales at Post-Intervention	-4.18 units on a scale Standard Deviation 17.42

SECONDARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Population: One participant was missing data on SADQ-10 at post-intervention

Total score (min: 0, max: 30, higher scores indicate worse outcome); baseline-post-treatment; positive scores indicate improvement in symptoms, negative score indicate worsening of symptoms

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=10 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention	0.10 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Population: One participant was missing data from this measure at baseline.

Total score (min: 0, max: 30, higher scores indicate worse outcome); baseline-post-intervention; positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=10 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention	2.00 units on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Total score (min: 0, max: 40, higher scores indicate worse outcome); baseline-post-intervention; positive numbers indicate an improvement in symptoms, negative numbers indicate a worsening in symptoms

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=11 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Modified Perceived Stress Scale at Post-Intervention	3.36 units on a scale Standard Deviation 6.55

SECONDARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Total score (min: 1, max: 5), baseline-post-intervention, positive numbers indicate a worsening of quality of life, negative numbers indicate an improvement in quality of life

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=11 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention	-.093 units on a scale Standard Deviation .258

SECONDARY outcome

Timeframe: through intervention completion, an average of 7 weeks

Total score (min: 10, max: 40, higher scores indicate better confidence); baseline-post-intervention, positive numbers indicate a worsening in communication confidence and negative numbers indicate an improvement in communication confidence

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=11 Participants Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being
Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention	-.818 units on a scale Standard Deviation 4.92

Adverse Events

Psychosocial Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Deena Schwen Blackett

University of Central Florida

Phone: 407-823-0909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place