Hearing Voices When No One is TalkingNCT06420024
ACT for Older Adults Who Hear Voices (HSCED)
A study testing Acceptance and Commitment Therapy in people with Hearing Voices When No One is Talking, run by University of Nottingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hearing Voices When No One is Talking
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Aug 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Currently experiences HV
- 65+ years of age
- Moderate levels of distress. This will be measured using recommended "Moderate" severity level cut-off scores on the Depression, Anxiety and Stress Scales-21 (Lovibond \& Lovibond, 1995) following the completion of Informed Consent Forms.
- Having capacity to provide informed consent (in accordance with the Mental Capacity Act)
- Willingness to engage in the intervention
Who cannot join
- Diagnosis of cognitive impairment or dementia (based on self-report), as this indicates a degree of cognitive impairment that would be difficult to accommodate for.
- Current engagement with another psychological therapy
- Unable to independently communicate in English without an interpreter (based on researcher's discretion at recruitment).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Derbyshire Healthcare NHS Foundation Trust
Derby, Derbyshire, DE22 3LZ
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Nottinghamshire, NG3 6AA
About this study
Official title: Acceptance and Commitment Therapy (ACT) for Older Adults Who Hear Voices: a Hermeneutic Single-case Efficacy Design (HSCED) Series
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 participant's 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.
Read more
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.
Read the 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 dementia/cognitive 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 People's 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
- Conditions
- Hearing Voices When No One is Talking
- Being tested
- Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
See: https://link.springer.com/chapter/10.1007/0-306-48581-8_1
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participant will receive ACT intervention Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voices Acceptance and Action Scale-9 (Brockman et al., 2015)
Acceptance-based attitudes and actions in relation to voices
Measured: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Beliefs about voices questionnaire-revised (Chadwick et al., 2000)
Beliefs, emotions, and behaviours relating to auditory hallucinations.
Measured: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Depression, Anxiety and Stress Scales-21 (Lovibond & Lovibond, 1995)
Depression, Anxiety and Stress
Measured: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Comprehensive assessment of Acceptance and Commitment Therapy processes, short-form (Morris et al., 2019)
Psychological flexibility
Measured: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Older People's Quality of Life questionnaire, brief version (Bowling et al., 2013)
Quality of Life
Measured: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
The Psychotic Symptom Rating Scales (Haddock et al., 1999) - Auditory Hallucination Sub-Scale
Symptom severity of auditory hallucinations
Measured: Approx. 0 weeks, 6 weeks, 12-14 weeks, 16-18 weeks following enrolment to the study.
Secondary outcomes (1)
Simplified Personal Questionnaire (Elliott et al., 1999)
Individualised client-generated goals
Measured: Weekly during the intervention (i.e., once per week during the intervention phase - this is anticipated to occur within the first 12-14 weeks of the participant's involvement with the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start2 Aug 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Voices When No One is TalkingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hermeneutic Single Case Efficacy Design
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust, Derbyshire Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Danielle De Boos, DClinPsy, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420024
- Sponsor's protocol ID
- 23007
- Status last verified
- Aug 2023
- First submitted
- 23 Mar 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy (ACT) for Older Adults Who Hear Voices: a Hermeneutic Single-case Efficacy Design (HSCED) Series
- ClinicalTrials.gov ID
- NCT06420024
- Acronym / sponsor ID
- 23007
- Conditions
- Hearing Voices When No One is Talking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust, Derbyshire Healthcare NHS Foundation Trust
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participant's 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 dementia/cognitive 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 People's 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hermeneutic Single Case Efficacy Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Acceptance and Commitment TherapyParticipant will receive ACT intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Currently experiences HV
- 65+ years of age
- Moderate levels of distress. This will be measured using recommended "Moderate" severity level cut-off scores on the Depression, Anxiety and Stress Scales-21 (Lovibond \& Lovibond, 1995) following the completion of Informed Consent Forms.
- Having capacity to provide informed consent (in accordance with the Mental Capacity Act)
- Willingness to engage in the intervention
Key exclusion criteria (3 listed)
- Diagnosis of cognitive impairment or dementia (based on self-report), as this indicates a degree of cognitive impairment that would be difficult to accommodate for.
- Current engagement with another psychological therapy
- Unable to independently communicate in English without an interpreter (based on researcher's discretion at recruitment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapySee: https://link.springer.com/chapter/10.1007/0-306-48581-8_1 | Behavioural | Intervention |
Primary outcome
Voices Acceptance and Action Scale-9 (Brockman et al., 2015)
Time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Acceptance-based attitudes and actions in relation to voices
Beliefs about voices questionnaire-revised (Chadwick et al., 2000)
Time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Beliefs, emotions, and behaviours relating to auditory hallucinations.
Depression, Anxiety and Stress Scales-21 (Lovibond & Lovibond, 1995)
Time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Depression, Anxiety and Stress
Comprehensive assessment of Acceptance and Commitment Therapy processes, short-form (Morris et al., 2019)
Time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Psychological flexibility
Older People's Quality of Life questionnaire, brief version (Bowling et al., 2013)
Time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.
Quality of Life
The Psychotic Symptom Rating Scales (Haddock et al., 1999) - Auditory Hallucination Sub-Scale
Time frame: Approx. 0 weeks, 6 weeks, 12-14 weeks, 16-18 weeks following enrolment to the study.
Symptom severity of auditory hallucinations
1 secondary outcome
Simplified Personal Questionnaire (Elliott et al., 1999)
Time frame: Weekly during the intervention (i.e., once per week during the intervention phase - this is anticipated to occur within the first 12-14 weeks of the participant's involvement with the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle De Boos, DClinPsy study chair
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Hearing Voices When No One is Talking, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voices Acceptance and Action Scale-9 (Brockman et al., 2015) (time frame: Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.