ACT for Older Adults Who Hear Voices (HSCED)

NCT06420024 | Completed DMC

• 1 other identifier: 23007
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Hearing Voices When No One is Talking

Outcome Measures

Primary Outcomes (6)

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

  Acceptance-based attitudes and actions in relation to voices

  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.

  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

  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

  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

  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

  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)

  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)

Study Arms (1)

Intervention

EXPERIMENTAL

Participant will receive ACT intervention

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Currently experiences HV
• + 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Nottinghamshire Healthcare NHS Trust: collaborator
• Derbyshire Healthcare NHS Foundation Trust: collaborator

Study Sites (2)

Derbyshire Healthcare NHS Foundation Trust

Derby, Derbyshire, DE22 3LZ, United Kingdom

Location

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Danielle De Boos, DClinPsy

  University of Nottingham

  STUDY CHAIR

Study Design

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

Model Details: Hermeneutic Single Case Efficacy Design

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 17, 2024
• Study Start: August 2, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)