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One-third of stroke survivors experience post-stroke depression, but there are currently no official guidelines for supporting them. Researchers aim to investigate whether the wisdom enhancement timeline technique can reduce depression in stroke survivors. The investigators also want to understand how this technique positively impacts mood, identity, self-esteem, and wisdom. The study will involve nine stroke survivors from the National Health Service (NHS) to gain insights into effective ways to support those with post-stroke depression.
One-third of stroke survivors have post-stroke depression. Finding ways to help them feel more positive after such a challenging event can be tricky. Right now, there are no official guidelines on the best way to support post-stroke depression, and research into this is still growing. That is why the investigators want to see if the wisdom enhancement timeline can improve the mood and overall well-being of people who have had a stroke.
In this study, the investigators have two goals. First, the investigators want to see if the wisdom enhancement timeline technique can reduce depression in stroke survivors. Second, the investigators aim to discover how this technique brings positive mood changes.
The main question the investigators want to answer
It is hypothesised that wisdom will improve first following the session where wisdom is applied. This will then be followed by either identity or self-esteem, with mood improving last.
To carry out this study, the investigators will work with three stroke survivors receiving care from the National Health Service (NHS). By focusing on this smaller group, the investigators hope to gain insights into the effectiveness of the technique in reducing depression and enhancing the lives of stroke survivors. This study is essential as it could help the investigators understand the best way to support those with post-stroke depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Wisdom Enhancement Timeline Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timeline Intervention | Other | The proposed intervention consists of six sessions. In Session One, the focus is on building rapport, assessing individual difficulties, setting client-focused goals, and introducing the timeline. Participants complete timeline examples during the session and as homework. In Session Two, psychoeducation is provided regarding the impact of stroke, addressing changes in identity and associated feelings of grievance. Session Three onwards introduces active change methods, encouraging reflection on complex life events. The aim is to promote resilience, meaning, self-compassion, and self-acceptance by exploring past coping strategies and finding significance in events of regret. This framework aims to enhance research on complex interventions, considering efficacy, effectiveness, theory-based approaches, and systems perspectives. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) - Mood | 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. | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
| Visual Analogue Scale (VAS) - Identity | 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. | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
| Visual Analogue Scale (VAS) - Wisdom | 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. | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
| Visual Analogue Scale (VAS) - Self-esteem | 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. | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 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. | Baseline to end of 6-week intervention phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan T Hassan, PGDIP CBT | University of East Anglia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of East Anglia | Norwich | NR4 7TJ | United Kingdom |
Following submission of the thesis, the entire documentation will be stored on the universities repository.
All information will be kept on the University of East Anglia's repository. This will remain there for 10 years. All participant information will be anonymised to protect their confidentiality.
No criteria
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No participants were excluded.
Participants were recruited via a local NHS Stroke service. 3 consented to participate in the trial with all completing it.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale (VAS) - Mood | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
|
10 weeks
All participants (n=3) were monitored for adverse events via non-systematic self-report and clinician observation throughout the 10-week study period. No deaths, serious adverse events, or other adverse events were observed. No deviations from ClinicalTrials.gov definitions were made.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ercan Hassan (Trainee Clinical Psychologist) | University of East Anglia | 07496337806 | nue22cyu@uea.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Aug 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Participants |
|
| Sex: Female, Male | Self-reported sex at enrollment. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| PHQ-9 Score at Baseline | Patient Health Questionnaire-9 total score, range 0-27; higher scores indicate more severe depressive symptoms. | Mean | Standard Deviation | Score 0-27 |
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| Primary | Visual Analogue Scale (VAS) - Identity | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
|
|
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| Primary | Visual Analogue Scale (VAS) - Wisdom | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
|
|
|
| Primary | Visual Analogue Scale (VAS) - Self-esteem | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length) |
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| Secondary | Patient Health Questionnaire (PHQ-9) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to end of 6-week intervention phase |
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |