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The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial.

Freeman D, Startup H, Myers E, Harvey A, Geddes J, Yu LM, Zaiwalla Z, Luengo-Fernandez R, Foster R, Lister R - Trials (2013)

Bottom Line: The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual.All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle.It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK. Daniel.Freeman@psych.ox.ac.uk

ABSTRACT

Background: Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation.

Methods/design: We will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014.

Discussion: This will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.

Trial registration: Current Controlled Trials ISRCTN 33695128.

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Related in: MedlinePlus

Flow diagram for the BEST study.
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Figure 1: Flow diagram for the BEST study.

Mentions: This is a prospective randomized pilot study to evaluate CBT-I in addition to standard psychiatric care versus standard psychiatric care alone in patients with distressing delusions or hallucinations (see Figure 1). A psychological intervention control group is not included in the design. We will instead examine how the treatment works by including repeated measures of insomnia and associated processes. Non-specific therapist factors will also be assessed [17]. A two-group design makes the successful completion of the trial much more feasible, while the addition of a third group would not add value in this instance. Randomization will be carried out independently by an on-line system developed by the Oxford Cognitive Health and Neuroscience Clinical Trials Unit. The randomizer programme will balance the following three variables: (i) sex (male, female), (ii) sleep problem severity (low, 15 to 21 on the Insomnia Severity Index (ISI); high, 22 to 28 on the ISI), and (iii) symptoms (hallucination only, delusions only, hallucinations and delusions). The trial therapist will inform patients of the randomization outcome, so that the research worker does not become unblinded. Rater assessments will be blind. All patients will be informed of allocation by the trial therapist to prevent the research assessors becoming unblinded. Precautionary strategies will include encouraging the therapist to consider room use and diary arrangements in the light of potential breaks of masking and reminding patients by the assessor not to talk about treatment allocation. Also, after the initial assessment, the assessor will not look at the patient’s clinical notes until the last of the ratings has been collected. The success of the blinding will be monitored; if there are breaks in the blinding, another assessor will be used from our research group. The reliability of the rater on the key interviewer measures will be formally assessed. The trial has received approval from the NHS Research Ethics Committee South Central, Oxford C (reference 12/SC/0138).


The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial.

Freeman D, Startup H, Myers E, Harvey A, Geddes J, Yu LM, Zaiwalla Z, Luengo-Fernandez R, Foster R, Lister R - Trials (2013)

Flow diagram for the BEST study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3717119&req=5

Figure 1: Flow diagram for the BEST study.
Mentions: This is a prospective randomized pilot study to evaluate CBT-I in addition to standard psychiatric care versus standard psychiatric care alone in patients with distressing delusions or hallucinations (see Figure 1). A psychological intervention control group is not included in the design. We will instead examine how the treatment works by including repeated measures of insomnia and associated processes. Non-specific therapist factors will also be assessed [17]. A two-group design makes the successful completion of the trial much more feasible, while the addition of a third group would not add value in this instance. Randomization will be carried out independently by an on-line system developed by the Oxford Cognitive Health and Neuroscience Clinical Trials Unit. The randomizer programme will balance the following three variables: (i) sex (male, female), (ii) sleep problem severity (low, 15 to 21 on the Insomnia Severity Index (ISI); high, 22 to 28 on the ISI), and (iii) symptoms (hallucination only, delusions only, hallucinations and delusions). The trial therapist will inform patients of the randomization outcome, so that the research worker does not become unblinded. Rater assessments will be blind. All patients will be informed of allocation by the trial therapist to prevent the research assessors becoming unblinded. Precautionary strategies will include encouraging the therapist to consider room use and diary arrangements in the light of potential breaks of masking and reminding patients by the assessor not to talk about treatment allocation. Also, after the initial assessment, the assessor will not look at the patient’s clinical notes until the last of the ratings has been collected. The success of the blinding will be monitored; if there are breaks in the blinding, another assessor will be used from our research group. The reliability of the rater on the key interviewer measures will be formally assessed. The trial has received approval from the NHS Research Ethics Committee South Central, Oxford C (reference 12/SC/0138).

Bottom Line: The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual.All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle.It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK. Daniel.Freeman@psych.ox.ac.uk

ABSTRACT

Background: Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation.

Methods/design: We will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014.

Discussion: This will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.

Trial registration: Current Controlled Trials ISRCTN 33695128.

Show MeSH
Related in: MedlinePlus