- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06451965
SCED - Wisdom Enhancement for Post-Stroke Depression (WE-PSD)
A Single Case Experiment Design Investigating Wisdom Enhancement to Augment CBT Outcomes for Depression in Post-Stroke Populations
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Norwich, United Kingdom, NR4 7TJ
- University of East Anglia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS) - Mood
Time Frame: Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
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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
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.
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Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
|
|
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.
|
Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
|
|
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.
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Daily during baseline phase and intervention phase (total of 8-10 weeks depending on baseline length)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline to end of 6-week intervention phase
|
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.
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Baseline to end of 6-week intervention phase
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ercan T Hassan, PGDIP CBT, University of East Anglia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 335191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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