Trial Outcomes & Findings for Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia (NCT NCT04318951)
NCT ID: NCT04318951
Last Updated: 2024-07-05
Results Overview
This self-report measure of depression severity is derived from a standardized questionnaire known for its good psychometric properties, including construct validity and test-retest reliability, in individuals without aphasia. Scale range: 0-120. Higher values represent higher degree of depression.
COMPLETED
NA
60 participants
Change from 1 day before start of treatment until immediately after 4 weeks of treatment.
2024-07-05
Participant Flow
Participant milestones
| Measure |
Intensive Communicative-pragmatic Social Interaction.
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia
Baseline characteristics by cohort
| Measure |
Intensive Communicative-pragmatic Social Interaction.
n=30 Participants
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
n=30 Participants
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
74.7 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
72.0 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
BDI.
|
28.2 units on a scale
STANDARD_DEVIATION 6.2 • n=93 Participants
|
24.0 units on a scale
STANDARD_DEVIATION 3.4 • n=4 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 14.1 • n=27 Participants
|
PRIMARY outcome
Timeframe: Change from 1 day before start of treatment until immediately after 4 weeks of treatment.Population: Post-Stroke Depression and Subacute Aphasia
This self-report measure of depression severity is derived from a standardized questionnaire known for its good psychometric properties, including construct validity and test-retest reliability, in individuals without aphasia. Scale range: 0-120. Higher values represent higher degree of depression.
Outcome measures
| Measure |
Intensive Communicative-pragmatic Social Interaction.
n=30 Participants
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
n=30 Participants
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
|---|---|---|
|
Change in Beck's Depression Inventory, BDI.
|
-12.6 score on a scale
Interval -17.5 to -7.7
|
-5.8 score on a scale
Interval -11.7 to -2.6
|
PRIMARY outcome
Timeframe: Change from 1 day before start of treatment until immediately after 4 weeks of treatment.Population: Post-Stroke Depression and Subacute Aphasia
This clinician-rated measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability, in individuals without aphasia. Scale range: 0-35.
Outcome measures
| Measure |
Intensive Communicative-pragmatic Social Interaction.
n=30 Participants
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
n=30 Participants
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression, HAM-D. Higher Values Represent Higher Degree of Depression.
|
-5.0 score on a scale
Interval -6.4 to -3.6
|
-3.3 score on a scale
Interval -4.5 to -2.1
|
SECONDARY outcome
Timeframe: Immediately after 4 weeks of treatment (used only as an external criterion to explore the psychometric adequacy of the self-report co-primary outcome, the BDI)Population: Post-Stroke Depression and Subacute Aphasia
This self-report questionnaire was conceived to quantify a person's confidence to overcome obstacles encountered when completing a difficult task. Results are expressed on a Likert scale ranging from 0 (very low self-efficacy) to 3 (very high self-efficacy). Results are expressed as sum scores ranging from 0 (very low self-efficacy) to 30 (very high self-efficacy). Reduced self-efficacy is discussed as one risk factor for depression. This instrument was used only for cross-sectional assessment, not for longitudinal assessment, to serve as an external criterion to explore the psychometric adequacy of the self-report co-primary outcome, the BDI.
Outcome measures
| Measure |
Intensive Communicative-pragmatic Social Interaction.
n=30 Participants
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
n=30 Participants
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
|---|---|---|
|
Self-Efficacy Questionnaire.
|
20.1 score on a scale
Standard Deviation 7.1
|
18.3 score on a scale
Standard Deviation 7.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 1 day before start of treatment until immediately after 4 weeks of treatment.Population: Post-Stroke Depression and Subacute Aphasia
This standardized aphasia test battery was found to be sensitive to treatment-induced short-term progress in language performance. To address the potential relationship between changes in cognitive-affective distress and verbal expression skills, we will use the combined AAT subscales "Repetition" and "Naming" as a covariate in exploratory evaluations. The AAT subscales "Repetition" and "Naming" as well as the resulting combined average score are based on a T-score distribution (M = 50; SD = 10). Higher T-scores represent better verbal expression skills. The results below indicate change over time.
Outcome measures
| Measure |
Intensive Communicative-pragmatic Social Interaction.
n=30 Participants
Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction: ILAT requires individuals with aphasia to engage in social interaction.
|
Standard Care.
n=30 Participants
All participants will receive standard care.
Standard care.: Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
|
|---|---|---|
|
Change in Aachen Aphasia Test, AAT.
|
3.5 T-score
Interval 2.0 to 5.0
|
2.9 T-score
Interval 1.0 to 4.8
|
Adverse Events
Intensive Communicative-pragmatic Social Interaction.
Standard Care.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place