Trial Outcomes & Findings for SCED - Wisdom Enhancement for Post-Stroke Depression (NCT NCT06451965)

Results Overview

A single-item Visual Analogue Scale was used to assess mood, rated daily on a 0-10 scale, where 0 indicates "worst possible mood" and 10 indicates "best possible mood." Three participants recorded their rating once each day throughout the trial.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)

Results posted on

2025-09-30

Participant Flow

Participants were recruited via a local NHS Stroke service. 3 consented to participate in the trial with all completing it.

No participants were excluded.

Participant milestones

Participant milestones
Measure	Experimental: Wisdom Enhancement Timeline Intervention Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Overall Study STARTED	3
Overall Study Baseline Phase - 2 Weeks	1
Overall Study Baseline Phase - 3 Weeks	1
Overall Study Baseline Phase - 4 Weeks	1
Overall Study Intervention Phase	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=3 Participants
Age, Categorical >=65 years	1 Participants n=3 Participants
Sex: Female, Male Female	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants
PHQ-9 Score at Baseline	16.33 Score 0-27 STANDARD_DEVIATION 4.62 • n=3 Participants

PRIMARY outcome

Timeframe: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)

Population: All three participants who started the study were included in the analysis. Daily visual analogue scale ratings for mood (0-10) were collected throughout each participant's baseline and intervention phases. The values reported in the table represent the mean (SD) of all daily ratings across each phase for all participants. No participants were excluded from this analysis.

A single-item Visual Analogue Scale was used to assess mood, rated daily on a 0-10 scale, where 0 indicates "worst possible mood" and 10 indicates "best possible mood." Three participants recorded their rating once each day throughout the trial.

Outcome measures

Outcome measures
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Visual Analogue Scale (VAS) - Mood Baseline phase (mean across participants)	3.53 Scores on a scale Standard Deviation 0.81
Visual Analogue Scale (VAS) - Mood Intervention phase (mean across participants)	5.23 Scores on a scale Standard Deviation 1.85

PRIMARY outcome

Timeframe: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)

Population: All three participants who started the study were included in the analysis. Daily visual analogue scale ratings for mood (0-10) were collected throughout each participant's baseline and intervention phases. The values reported in the table represent the mean (SD) of all daily ratings across each phase for all participants. No participants were excluded from this analysis.

A single-item Visual Analogue Scale was used to assess identity, rated daily on a 0-10 scale, where 0 indicates "a disconnect from who they are" and 10 indicates "complete connection." Three participants recorded their rating once each day throughout the baseline and intervention phases.

Outcome measures

Outcome measures
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Visual Analogue Scale (VAS) - Identity Baseline phase (mean across participants)	2.55 Scores on a scale Standard Deviation 1.21
Visual Analogue Scale (VAS) - Identity Intervention phase (mean across participants)	5.09 Scores on a scale Standard Deviation 2.33

PRIMARY outcome

Timeframe: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)

Population: All three participants who started the study were included in the analysis. Daily visual analogue scale ratings for mood (0-10) were collected throughout each participant's baseline and intervention phases. The values reported in the table represent the mean (SD) of all daily ratings across each phase for all participants. No participants were excluded from this analysis.

A single-item Visual Analogue Scale was used to assess Wisdom, rated daily on a 0-10 scale, where 0 indicates "low wisdom" and 10 indicates "high wisdom." Participants recorded their rating once each day throughout the baseline and intervention phases.

Outcome measures

Outcome measures
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Visual Analogue Scale (VAS) - Wisdom Baseline phase (mean across participants)	2.79 Scores on a scale Standard Deviation 1.33
Visual Analogue Scale (VAS) - Wisdom Intervention phase (mean across participants)	5.56 Scores on a scale Standard Deviation 2.08

PRIMARY outcome

Timeframe: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)

Population: All three participants who started the study were included in the analysis. Daily visual analogue scale ratings for mood (0-10) were collected throughout each participant's baseline and intervention phases. The values reported in the table represent the mean (SD) of all daily ratings across each phase for all participants. No participants were excluded from this analysis.

A single-item Visual Analogue Scale was used to assess self-esteem, rated daily on a 0-10 scale, where 0 indicates "low self-esteem" and 10 indicates "high self-esteem." Participants recorded their rating once each day throughout the baseline and intervention phases.

Outcome measures

Outcome measures
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Visual Analogue Scale (VAS) - Self-esteem Baseline phase (mean across participants)	3 Scores on a scale Standard Deviation 0.96
Visual Analogue Scale (VAS) - Self-esteem Intervention phase (mean across participants)	4.92 Scores on a scale Standard Deviation 2.01

SECONDARY outcome

Timeframe: Baseline to end of 6-week intervention phase

Population: All three participants who started the study were included in the analysis. The PHQ-9 was administered at the start of the baseline phase (week 0, pre-intervention) and again at the end of the intervention phase (week 8-10, depending on baseline duration). The values reported in the table represent the mean (SD) of participants' total scores at these time points. No participants were excluded from this analysis.

The PHQ-9 is a 9-item self-report measure assessing the severity of depressive symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), producing a total score between 0 and 27, with higher scores indicating more severe depression.

Outcome measures

Outcome measures
Measure	Experimental: Wisdom Enhancement Timeline Intervention n=3 Participants Participants first complete a baseline observation phase of 2, 3, or 4 weeks (duration randomly assigned). During this phase, no intervention is provided and daily visual analogue scale ratings are recorded, along with administration of the PHQ-9 at the start of the phase. The baseline phase is then followed by six weekly one-hour therapy sessions delivering the Wisdom Enhancement Timeline intervention, during which daily ratings continued and the PHQ-9 was administered again at the end.
Patient Health Questionnaire (PHQ-9) Baseline (week 0, pre-intervention)	13.66 Scores on a scale Standard Deviation 4.61
Patient Health Questionnaire (PHQ-9) Post-intervention (week 8-10)	7.33 Scores on a scale Standard Deviation 1.15

Adverse Events

Experimental: Wisdom Enhancement Timeline 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

Ercan Hassan (Trainee Clinical Psychologist)

University of East Anglia

Phone: 07496337806

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place