Post-stroke DepressionWE-PSDNCT06451965
SCED - Wisdom Enhancement for Post-Stroke Depression
A study testing Timeline Intervention in people with Post-stroke Depression, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Timeline Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Had a stroke.
- Those who self-report as having difficulties with depression to a clinician.
- Have sufficient cognitive and communication abilities for informed consent and active engagement
Who cannot join
- Under the age of 18. Because this is the age when they are treated as an adult by UK law.
- Severe cognitive impairments or mental health difficulties that would hinder task engagement or provide informed consent.
- Medical instability jeopardising consistent participation or well-being.
- Significant risk concerns regarding safety to themselves or others.
- Substance use/dependency impacting adherence.
- Prescribed psychotropic medication less than 3 months ago.
- Currently involved in research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Case Experiment Design Investigating Wisdom Enhancement to Augment CBT Outcomes for Depression in Post-Stroke Populations
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.
Read the detailed description
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
- Does enhancing wisdom through the timeline technique improve psychological outcomes (mood, identity, self-esteem) in post-stroke depressed individuals?
- In post-stroke depressed individuals, is the improvement in wisdom the first indicator of subsequent improvements in identity, self-esteem, and mood?
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.
- Conditions
- Post-stroke Depression
- Being tested
- Timeline Intervention
- Keywords
- wisdom, CBT, cognitive behavioural therapy, stroke, depression
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Timeline Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
Secondary outcomes (1)
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.
Measured: Baseline to end of 6-week intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2023
- Primary completion21 Feb 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ercan T Hassan, PGDIP CBT, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451965
- Sponsor's protocol ID
- 335191
- Acronym
- WE-PSD
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following submission of the thesis, the entire documentation will be stored on the universities repository.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Case Experiment Design Investigating Wisdom Enhancement to Augment CBT Outcomes for Depression in Post-Stroke Populations
- ClinicalTrials.gov ID
- NCT06451965
- Acronym / sponsor ID
- WE-PSD / 335191
- Conditions
- Post-stroke Depression
- Keywords
- wisdom, CBT, cognitive behavioural therapy, stroke, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Does enhancing wisdom through the timeline technique improve psychological outcomes (mood, identity, self-esteem) in post-stroke depressed individuals?
- In post-stroke depressed individuals, is the improvement in wisdom the first indicator of subsequent improvements in identity, self-esteem, and mood?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Wisdom Enhancement Timeline Intervention | Experimental | Other: Timeline InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Had a stroke.
- Those who self-report as having difficulties with depression to a clinician.
- Have sufficient cognitive and communication abilities for informed consent and active engagement
Key exclusion criteria (7 listed)
- Under the age of 18. Because this is the age when they are treated as an adult by UK law.
- Severe cognitive impairments or mental health difficulties that would hinder task engagement or provide informed consent.
- Medical instability jeopardising consistent participation or well-being.
- Significant risk concerns regarding safety to themselves or others.
- Substance use/dependency impacting adherence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timeline InterventionThe 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. | Other | Experimental: Wisdom Enhancement Timeline Intervention |
Primary outcome
Visual Analogue Scale (VAS) - Mood
Time frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
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.
Visual Analogue Scale (VAS) - Identity
Time frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
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.
Visual Analogue Scale (VAS) - Wisdom
Time frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
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.
Visual Analogue Scale (VAS) - Self-esteem
Time frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
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.
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to end of 6-week intervention phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Following submission of the thesis, the entire documentation will be stored on the universities repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ercan T Hassan, PGDIP CBT principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timeline Intervention in people with Post-stroke Depression, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) - Mood (time frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.