Evaluating a novel smartphone-assisted coping focused intervention for people who experience distressing voices (SAVVy)

Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: 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. CONDITION: Auditory hallucinations Hearing Voices Mental Disorders Psychotic Disorders PRIMARY OUTCOME: Acceptability of different components of SAVVy intervention (one‐to‐one sessions, smarpthone app, feedback): quantitative acceptability measure designed specifically for this study; qualitative interview designed specifically for this study Feasibility: level of engagement with intervention sessions rated by the therapist following each session; number of times the EMI coping strategy reminders are viewed; response rates to EMA items; fidelity to intervention protocol rated by the therapist following each session; study recruitment and retention rates Psychotic Symptom Rating Scales ‐ Auditory Hallucinations (PSYRATS‐AH) ‐ Total Score SECONDARY OUTCOME: Depression, Anxiety Stress Scale‐21 (DASS‐21) Subjective Experience of Psychosis Scale (SEPS) – Negative Impact Subscale INCLUSION CRITERIA: 1. Over the age of 18 2. Sufficient conversational English for meaningful participation in the study 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 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)
Epistemonikos ID: f2bdf2043c8b4b0c135843d698c2603b8c384c85
First added on: Aug 25, 2024