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Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial.

Hayward M, Strauss C, Bogen-Johnston L - Trials (2014)

Bottom Line: This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists.Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT.If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices.

View Article: PubMed Central - PubMed

Affiliation: School of Psychology, University of Sussex, BN1 9RH Brighton, UK. mih21@sussex.ac.uk.

ABSTRACT

Background: Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes, but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing. An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective. This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists.

Methods/design: An external pilot randomized controlled trial (RCT) comparing outcomes for 15 patients receiving 16 hours (weekly sessions of one hour) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment. Participants will be assessed using questionnaires at baseline, 16 weeks (post-intervention), and 36 weeks (follow-up).

Discussion: Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT. If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices.

Trial registration: Current Controlled Trials ISRCTN registration number 44114663. Registered on 13 June 2013.

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Related in: MedlinePlus

Flow diagram for R2V trial.
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Fig1: Flow diagram for R2V trial.

Mentions: An external pilot RCT will compare the outcomes for patients receiving the RT intervention (in addition to their usual treatment) to outcomes for patients receiving only their usual treatment. Participants who consent will be randomized to either RT (plus treatment-as-usual) or to treatment-as-usual (TAU) only (see Figure 1). Randomization will be conducted by a statistician independent to the research team. Outcomes will be assessed at baseline (pre-randomization - Time 0), 16 weeks (post-intervention - Time 1), and 36 weeks (follow-up - Time 2). Time 1 and 2 assessments will be conducted blind by a researcher independent of the therapy process. Adherence to the therapy protocol will be assessed by an independent rater assessing a random selection of early, middle, and late recorded sessions using a modified version of the cognitive therapy checklist [22].Figure 1


Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial.

Hayward M, Strauss C, Bogen-Johnston L - Trials (2014)

Flow diagram for R2V trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4150948&req=5

Fig1: Flow diagram for R2V trial.
Mentions: An external pilot RCT will compare the outcomes for patients receiving the RT intervention (in addition to their usual treatment) to outcomes for patients receiving only their usual treatment. Participants who consent will be randomized to either RT (plus treatment-as-usual) or to treatment-as-usual (TAU) only (see Figure 1). Randomization will be conducted by a statistician independent to the research team. Outcomes will be assessed at baseline (pre-randomization - Time 0), 16 weeks (post-intervention - Time 1), and 36 weeks (follow-up - Time 2). Time 1 and 2 assessments will be conducted blind by a researcher independent of the therapy process. Adherence to the therapy protocol will be assessed by an independent rater assessing a random selection of early, middle, and late recorded sessions using a modified version of the cognitive therapy checklist [22].Figure 1

Bottom Line: This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists.Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT.If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices.

View Article: PubMed Central - PubMed

Affiliation: School of Psychology, University of Sussex, BN1 9RH Brighton, UK. mih21@sussex.ac.uk.

ABSTRACT

Background: Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes, but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing. An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective. This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists.

Methods/design: An external pilot randomized controlled trial (RCT) comparing outcomes for 15 patients receiving 16 hours (weekly sessions of one hour) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment. Participants will be assessed using questionnaires at baseline, 16 weeks (post-intervention), and 36 weeks (follow-up).

Discussion: Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT. If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices.

Trial registration: Current Controlled Trials ISRCTN registration number 44114663. Registered on 13 June 2013.

Show MeSH
Related in: MedlinePlus