Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial
Open accessAbstract
BACKGROUND: Cognitive behavior therapy for psychosis (CBTp) is an effective intervention for people who hear distressing voices (auditory hallucinations). However, there continues to be a problem of poor access to CBTp. Constraints on health care funding require this problem to be addressed without a substantial increase in funding. One solution is to develop guided self-help forms of CBTp to improve access, and a symptom-specific focus on, for example, distressing voices (auditory verbal hallucinations) has the potential to enhance effectiveness. We term this cognitive behavior therapy for distressing voices (CBTv). METHODS/DESIGN: This trial is an external pilot randomized controlled trial comparing the effects of 12-week guided self-help CBTv (with eight therapist support sessions) with a wait list control condition. Informed consent will be obtained from each participant. Half of the 30 participants will be randomized to receive guided self-help CBTv immediately; the remaining half will receive the intervention after a 12-week delay. All participants will continue with their usual treatment throughout the study. Outcomes will be assessed using questionnaires completed at baseline and 12 weeks postrandomization. Interviews will be offered to all those who receive therapy immediately to explore their experiences with the intervention. DISCUSSION: The outcomes of this trial, both quantitative and qualitative, will inform the design of a definitive randomized controlled trial of guided self-help CBTv. If this intervention is effective, it could help to increase access to CBT for those who hear distressing voices. TRIAL REGISTRATION: ISRCTN registration number ISRCTN77762753 . Registered on 23 July 2015.
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In a pilot RCT of GiVE compared to usual care (N=28), there was a very large between-groups effect for negative voice impact (d = 1.78).
“a very large between-groups effect for the pre-determined primary outcome of negative voice impact (d = 1.78) [23]”
From Increasing access to CBT for psychosis patients: A feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2) (2020) · cites this paper as [22]
The Methods/design > Planned analysis section says analyses will be carried out after data collection and that between-group Cohen’s d values will be reported; it does not report an observed effect. The Methods/design section plans to recruit 30 participants, rather than reporting an N=28 trial result. This protocol therefore does not substantiate the claimed d=1.78 finding. (LLM, conf=0.85)
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Experimental — accuracy not yet measuredThe GiVE intervention package can be delivered by expert therapists with benefits for patients.
“confirming that it can be delivered by expert therapists with benefits for patients”
From Increasing access to CBT for psychosis patients: A feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2) (2020) · cites this paper as [22]
The Planned intervention section says GiVE will be guided by clinical psychologists with expertise in CBTp. But this paper is a trial protocol, not a report confirming delivery or patient benefits; the Abstract’s Discussion says effectiveness remains to be tested. No page numbers are available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn a pilot RCT of GiVE compared to usual care (N=28), retention within the study was 96%.
“Results were encouraging with high levels of retention within the study (96%)”
From Increasing access to CBT for psychosis patients: A feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2) (2020) · cites this paper as [22]
The Methods/design and Planned analysis sections describe a proposed GiVE pilot RCT and say retention rates will be reported after data collection. Our copy reports neither an actual sample of 28 nor a 96% retention result (searched: 96% retention, 28 participants, study dropout). No page numbers are available in the indexed passages. (LLM, conf=0.78)
Experimental — accuracy not yet measured
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References 45 · Cited by 15
- Authors
- Hazell, C. M., Hayward, M., Cavanagh, K., Jones, A.-M., & Strauss, C.
- Affiliations
- University of Sussex (GB)
- Corresponding author
- Strauss, Clara
- Venue
- Trials
- Published
- 2016-07-26
- Volume
- 17
- Issue
- 1
- Pages
- 351-351
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4960672
- OpenAlex
- W2476610062
- Cited by
- 15
- References
- 45
- Citations by year
- 2025: 2 · 2024: 3 · 2020: 2 · 2019: 3 · 2018: 3 · 2017: 2
- FWCI
- 4.11
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- WestminsterResearch (University of Westminster) (acceptedVersion, cc-by)
- Sussex Research Online (University of Sussex) (submittedVersion, cc-by)
- Figshare (submittedVersion, cc-by)
- Funders
- Economic and Social Research Council (ES/J500173/1)
- Sussex Partnership NHS Foundation Trust (na)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- auditory verbal hallucinations, distressing voices, guided self-help, access to mental health care, therapist support, psychosis treatment
- MeSH terms
- Adaptation, Psychological, Auditory Perception, Clinical Protocols, England, Hallucinations, Humans, Pilot Projects, Surveys and Questionnaires, Research Design, Self Care, Self Concept, Time Factors, Cognitive Behavioral Therapy, Single-Blind Method, Treatment Outcome
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