SCED - Wisdom Enhancement for Post-Stroke Depression (WE-PSD)

September 9, 2025 updated by: University of East Anglia

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.

Study Overview

Status

Completed

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

  1. Does enhancing wisdom through the timeline technique improve psychological outcomes (mood, identity, self-esteem) in post-stroke depressed individuals?
  2. 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

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Norwich, United Kingdom, NR4 7TJ
        • University of East Anglia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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.
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.
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.
Baseline to end of 6-week intervention phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ercan T Hassan, PGDIP CBT, University of East Anglia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

March 6, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following submission of the thesis, the entire documentation will be stored on the universities repository.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

No 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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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