SCED - Wisdom Enhancement for Post-Stroke Depression

NCT06451965 | Completed Results

• 1 other identifier: 335191
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-stroke Depression

Keywords

wisdom; CBT; cognitive behavioural therapy; stroke; depression

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  Baseline to end of 6-week intervention phase

Study Arms (1)

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.

Other: Timeline Intervention

Interventions

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.

Experimental: Wisdom Enhancement Timeline Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

University of East Anglia

Norwich, NR4 7TJ, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ercan Hassan (Trainee Clinical Psychologist)
• Organization: University of East Anglia

nue22cyu@uea.ac.uk

07496337806

Study Officials

• Ercan T Hassan, PGDIP CBT

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: September 1, 2023
• Primary Completion: February 21, 2025
• Study Completion: March 6, 2025
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: No criteria

Locations

GB (1)