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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06451965
Other study ID # 335191
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 1, 2025

Study information

Verified date May 2024
Source University of East Anglia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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 is whether using this technique can reduce feelings of depression in people who have had a stroke. the investigators expect a positive change in how stroke survivors rate their mood before and after using the technique. the investigators also expect that as their mood improves, other aspects, such as their sense of identity, self-esteem, and wisdom, will also improve. To carry out this study, the investigators will work with nine 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Timeline Intervention
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.

Locations

Country Name City State
United Kingdom University of East Anglia Norwich

Sponsors (1)

Lead Sponsor Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) Four questions, asking participants to rate on a 0-10 scale Daily from baseline to the end of the 10-week study.
Secondary Patient Health Questionnaire-9 Standardised questionnaire to measure depression Assessed at baseline and at the end of the 10-week study.
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