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CompletedNCT06420024Updated Aug 9, 2024

ACT for Older Adults Who Hear Voices (HSCED)

An interventional study of Acceptance and Commitment Therapy in Hearing Voices When No One is Talking, sponsored by University of Nottingham. Completed at 2 sites in United Kingdom. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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 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.

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

02

Conditions studied

  • Hearing Voices When No One is Talking
03

In context

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Intervention

    Participant will receive ACT intervention

    Behavioral: Acceptance and Commitment Therapy

Interventions

  • BehavioralAcceptance and Commitment Therapy

    See: https://link.springer.com/chapter/10.1007/0-306-48581-8_1

06

What researchers measure

Primary outcomes

  1. Voices Acceptance and Action Scale-9 (Brockman et al., 2015)

    Acceptance-based attitudes and actions in relation to voices

    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.

  2. Beliefs about voices questionnaire-revised (Chadwick et al., 2000)

    Beliefs, emotions, and behaviours relating to auditory hallucinations.

    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.

  3. Depression, Anxiety and Stress Scales-21 (Lovibond & Lovibond, 1995)

    Depression, Anxiety and Stress

    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.

  4. Comprehensive assessment of Acceptance and Commitment Therapy processes, short-form (Morris et al., 2019)

    Psychological flexibility

    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.

  5. Older People's Quality of Life questionnaire, brief version (Bowling et al., 2013)

    Quality of Life

    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.

  6. The Psychotic Symptom Rating Scales (Haddock et al., 1999) - Auditory Hallucination Sub-Scale

    Symptom severity of auditory hallucinations

    Time frame: 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

    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)

07

Study locations

2 sites
  • Derbyshire Healthcare NHS Foundation Trust
    Derby, Derbyshire DE22 3LZ, United Kingdom
  • Nottinghamshire Healthcare NHS Foundation Trust
    Nottingham, Nottinghamshire NG3 6AA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06420024
Lead sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Foundation Trust, Derbyshire Healthcare NHS Foundation Trust
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Aug 2, 2023
Primary completion
Jun 20, 2024
Completion
Jun 20, 2024
Last update
Aug 9, 2024

Study contacts

Danielle De Boos, DClinPsy
study chair · University of Nottingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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