Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420024
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-03-23
Brief Title:
ACT for Older Adults Who Hear Voices HSCED
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Acceptance and Commitment Therapy ACT for Older Adults Who Hear Voices a Hermeneutic Single-case Efficacy Design HSCED Series
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hearing voices often referred to as auditory hallucinations is a common experience amongst the older adult population those 65 years of age and can be associated with increased psychological distress Acceptance and Commitment Therapy ACT is a psychological therapy that aims to reduce distress of hearing voices by altering the relationship someone has with voices and has been shown to improve distress levels for working age adults who hear voices ACT also appears to be a suitable intervention for older adults distressed by hearing voices however there is currently no research that has examined this Therefore research is now needed to evaluate whether ACT can support older adults who experience distress from hearing voices
This study will use a case study based research method known as a Hermeneutic Single-Case Efficacy Design HSCED series This method will involve 3 participants who will receive ACT for hearing voices This will be delivered across approximately twelve 90-minute sessions Participants will be asked to complete measures that assess areas such as distress levels and quality of life which will be completed before during and after therapy A detailed report of each participants level of progress will then be generated and evaluated by expert judges This will determine whether progress has occurred as a direct result of the therapy or due to other reasons and allow conclusions to be drawn about the use of ACT for older adults distressed by hearing voices
Participants will be recruited from either Local Mental Health Teams at Nottinghamshire NHS Foundation Trust or from the Hearing Voices Group in Beeston Nottingham Participants will be required to be age 65 years and currently experience hearing voices that cause them distress
This study will be funded by the NHS and is estimated to last approximately 12-months with 5-months of participant involvement
This study will use a case study based research method known as a Hermeneutic Single-Case Efficacy Design HSCED series This method will involve 3 participants who will receive ACT for hearing voices This will be delivered across approximately twelve 90-minute sessions Participants will be asked to complete measures that assess areas such as distress levels and quality of life which will be completed before during and after therapy A detailed report of each participants level of progress will then be generated and evaluated by expert judges This will determine whether progress has occurred as a direct result of the therapy or due to other reasons and allow conclusions to be drawn about the use of ACT for older adults distressed by hearing voices
Participants will be recruited from either Local Mental Health Teams at Nottinghamshire NHS Foundation Trust or from the Hearing Voices Group in Beeston Nottingham Participants will be required to be age 65 years and currently experience hearing voices that cause them distress
This study will be funded by the NHS and is estimated to last approximately 12-months with 5-months of participant involvement
Detailed Description:
Chief Investigator
Dr Danielle De Boos
Objectives
To investigate the efficacy of Acceptance and Commitment Therapy for older adults who hear voices in a Hermeneutic Single-Case Efficacy Design series
Trial Configuration
Case study series recruited from multiple centres
Settings
Secondary care older adult mental health service and charity-based support groups
Sample size estimate
3
Number of participants
Three participants If a participant withdraws a replacement participant will be sought
Eligibility criteria
Individuals who are 65 years of age experience moderate levels of distress as defined by the Depression Anxiety and Stress Scales-21 have capacity to provide informed consent and express willingness to engage in the intervention are eligible to participate providing they do not have a diagnosis of dementiacognitive impairment are not currently receiving other psychological therapy and are able to independently communicate in English
Description of interventions
Acceptance and commitment therapy adapted to suit the needs of older adults Twelve sessions are expected to take place with a review at session six
Duration of study
Up to 20 months
Outcome measures
Personal Questionnaire simplified will be reviewed weekly
At baseline pre-therapy mid-therapy post-therapy and follow-up 4-6 weeks participants will complete the following outcome measures
Voices Acceptance and Action Scale-9
Beliefs about voices questionnaire-revised
Depression Anxiety and Stress Scales-21
Comprehensive assessment of Acceptance and Commitment Therapy processes short-form
Older Peoples Quality of Life questionnaire brief version
Psychotic Symptom Rating Scale Auditory Hallucination sub-scale
Participants will also complete a change interview post-therapy with Trainee Clinical Psychologist Jennifer Welch University of Nottingham University of Lincoln who is independent to this study
Statistical methods
Reliable Change Index adjudication panel Framework Analysis correlations visual analysis
Dr Danielle De Boos
Objectives
To investigate the efficacy of Acceptance and Commitment Therapy for older adults who hear voices in a Hermeneutic Single-Case Efficacy Design series
Trial Configuration
Case study series recruited from multiple centres
Settings
Secondary care older adult mental health service and charity-based support groups
Sample size estimate
3
Number of participants
Three participants If a participant withdraws a replacement participant will be sought
Eligibility criteria
Individuals who are 65 years of age experience moderate levels of distress as defined by the Depression Anxiety and Stress Scales-21 have capacity to provide informed consent and express willingness to engage in the intervention are eligible to participate providing they do not have a diagnosis of dementiacognitive impairment are not currently receiving other psychological therapy and are able to independently communicate in English
Description of interventions
Acceptance and commitment therapy adapted to suit the needs of older adults Twelve sessions are expected to take place with a review at session six
Duration of study
Up to 20 months
Outcome measures
Personal Questionnaire simplified will be reviewed weekly
At baseline pre-therapy mid-therapy post-therapy and follow-up 4-6 weeks participants will complete the following outcome measures
Voices Acceptance and Action Scale-9
Beliefs about voices questionnaire-revised
Depression Anxiety and Stress Scales-21
Comprehensive assessment of Acceptance and Commitment Therapy processes short-form
Older Peoples Quality of Life questionnaire brief version
Psychotic Symptom Rating Scale Auditory Hallucination sub-scale
Participants will also complete a change interview post-therapy with Trainee Clinical Psychologist Jennifer Welch University of Nottingham University of Lincoln who is independent to this study
Statistical methods
Reliable Change Index adjudication panel Framework Analysis correlations visual analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None