None listed
Conditions
Brief summary
Hearing voices are a phenomenon experienced in a number of mental disorders, especially schizophrenia, mood disorders and trauma-related disorders. Voice hearing can be persistent for many, resulting in a potentially distressing and disabling experience. Existing psychological treatments are effective for some, but costly to deliver, and require specialist expertise that is not widely available. New interventions have been called for that are simpler and more targeted, and which empower people to self-manage their own experiences. Such interventions may be enhanced by recent developments in e-mental health, particularly the use of smartphone technology. These technologies can increase accessibility, reduce costs, and promote autonomous recovery. An important development in e-mental health is the use of ecological momentary assessment (EMA) and intervention (EMI) in the context of treatment. EMA utilises mobile devices to collect multiple recordings of momentary experiences through self-monitoring in the context of the person’s daily life. This can provide individualised feedback on how symptoms evolve in real time in relation to the person’s environment, psychological processes, and how the person responds to them. EMI extends the use of smartphones to delivery of reminders and symptom self-management instructions during daily life. The aim of this work is to develop and evaluate a new intervention which unifies the unique monitoring capabilities of EMA with the momentary intervention capabilities of EMI in a coping-focused intervention for distressing voices (SAVVy: Smartphone-Assisted coping focused interVention for Voices). The second aim is to investigate variables which influence fluctuations in voice hearing experiences in daily life using EMA, in addition to increasing understanding of the nature and use of coping strategies in the daily life of voice hearers. The design of the current study is a randomised controlled trial (RCT) comparing a group of participants who will complete the SAVVy intervention whilst receiving regular treatment (17 participants), with a group only receiving regular treatment (17 participants). The intervention will involve receiving four, one-to-one sessions with a therapist whilst completing smartphone-based EMA and EMI between sessions. Information gathered during initial EMA monitoring of voice hearing experiences will be provided as feedback to participants during therapy and will inform the choice of specific coping strategies for self-managing the voices. The coping strategies will then be sent to participant via EMI reminders from the smartphone app between remaining sessions. Assessments will be taken before the intervention and 8 weeks following randomisation (post assessment blinded). The primary focus of this trial is to establish feasibility and acceptability of the intervention, and a preliminary indication of efficacy.
Interventions
Psychological intervention focusing on improving self-management of distressing voice hearing experiences (‘auditory hallucinations’). The intervention will involve receiving four, one hour, individual (one-to-one) sessions with a trained therapist spaced 7-14 days apart. The first session will involve psychoeducation regarding voice hearing experiences and exploration of the participant’s own experiences, discussing factors which influence their voices day-to-day, and training in how to use the
Psychological intervention focusing on improving self-management of distressing voice hearing experiences (‘auditory hallucinations’). The intervention will involve receiving four, one hour, individual (one-to-one) sessions with a trained therapist spaced 7-14 days apart. The first session will involve psychoeducation regarding voice hearing experiences and exploration of the participant’s own experiences, discussing factors which influence their voices day-to-day, and training in how to use the smartphone app. Between the first and second session, participants will answer multiple questionnaires via a smartphone app which records momentary voice hearing experiences and related variables such as mood and various responses to the voices (‘ecological momentary assessment’). Data recorded by the smartphone will then be analysed by the research team to identify potential within-person variables which influence fluctuations in the participant’s voices. This is then presented as feedback to participants in the second session (if such variables are detected by the data), which is then discussed in context of a basic functional model of antecedents and responses to voices. From this, coping strategies which may be helpful given this model are identified collaboratively. These coping strategies are then coded in to the app such that the smartphone sends reminders to participants of these strategies in daily life (‘ecological momentary intervention’). Session 3 and 4 involve reviewing these coping strategies and discussing feedback from the app regarding their use and helpfulness. The smartphone app automatically records when the participant uses the app in order to monitor adherence and engagement. The treatment group will receive the intervention alongside their usual treatment by their regular mental health providers (treatment-as-usual, TAU) which will continue without restriction from involvement in the trial. This will be delivered in the 2-month period immediately following randomisation. The intervention sessions will be conducted at a specialist clinic for people who experience persisting voices. A therapy manual specifically designed for this study will be followed by all therapists and fidelity to this protocol will be assessed using measures following each session.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over the age of 18 2. Sufficient conversational English for meaningful participation in the study 3. Current persisting auditory verbal hallucinations defined by, over the week preceding the baseline assessment, hearing a hallucinated voice or voices on at least four different occasions, AND/OR on one or more occasion and lasting for at least an hour (score of 3 or more on PSYRATS-AH item 2) 4. Experiencing distress due to the voices (score of 1 or more on PSYRATS-AH item 8) 5. Experiencing auditory verbal hallucinations for at least 6 months 6. Willing to use the smartphone app during the trial
Exclusion criteria
1. Unable to provide informed consent 2. Intellectual disability (Wechsler Test of Adult Reading estimated IQ < 70) 3. Voices occur solely in the context of substance use 4. Initiation of a new antipsychotic medication within the previous eight weeks 5. Too distressed or agitated to take part in the study 6. Current risk of harm to self or others that requires active crisis management
Outcome results
None listed