Dataset Information

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).

ABSTRACT:

Background

The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that maintain distress. We have developed a brief form of CBTp for distressing voices and reported preliminary evidence for its effectiveness when delivered by highly trained therapists (clinical psychologists). This study will investigate the delivery of this intervention by a cost-effective workforce of assistant psychologists following a brief training and evaluate the acceptability and feasibility of conducting a future, definitive, randomised controlled trial (RCT).

Methods

This is a feasibility study for a pragmatic, three-arm, parallel-group, superiority 1:1:1 RCT comparing a Guided self-help CBT intervention for voices and treatment as usual (GiVE) to Supportive Counselling and treatment as usual (SC) to treatment as usual alone (TAU), recruiting across two sites, with blinded post-treatment and follow-up assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience.

Discussion

Expected outcomes will include an assessment of the feasibility of conducting a definitive RCT, and data to inform the calculation of its sample size. If evidence from a subsequent, fully powered RCT suggests that GiVE is clinically and cost-effective when delivered by briefly trained assistant psychologists, CBTp offered in these less resource-intensive forms has the potential to generate benefits for individual patients (reduced distress, enhanced recovery and enhanced quality of life), service-level patient benefit (increased access to evidence-based psychological therapies) and economic benefits to the NHS (in terms of the reduced use of mental health inpatient services).

Trial registration

Current Controlled Trials, ISRCTN registration number: 16166070. Registered on 5 February 2019.

SUBMITTER: Hayward M

PROVIDER: S-EPMC7110645 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).

Hayward Mark M Berry Clio C Cameron Ben B Arnold Kate K Berry Katherine K Bremner Stephen S Cavanagh Kate K Fowler David D Gage Heather H Greenwood Kathryn K Hazell Cassie C Jones Anna-Marie AM Robertson Sam S Strauss Clara C

Trials 20200401 1

<h4>Background</h4>The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that ...[more]

PMID: 32238176

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Project description:This paper presents an outline of voice-hearing phenomenology in the context of evolutionary mechanisms for self- and social- monitoring. Special attention is given to evolved systems for monitoring dominant-subordinate social roles and relationships. These provide information relating to the interpersonal motivation of others, such as neutral, friendly or hostile, and thus the interpersonal threat, versus safe, social location. Individuals who perceive themselves as subordinate and dominants as hostile are highly vigilant to down-rank threat and use submissive displays and social spacing as basic defenses. We suggest these defense mechanisms are especially attuned in some individuals with voices, in which this fearful-subordinate - hostile-dominant relationship is played out. Given the evolved motivational system in which voice-hearers can be trapped, one therapeutic solution is to help them switch into different motivational systems, particularly those linked to social caring and support, rather than hostile competition. Compassion focused therapy (CFT) seeks to produce such motivational shifts. Compassion focused therapy aims to help voice-hearers, (i) notice their threat-based (dominant-subordinate) motivational systems when they arise, (ii) understand their function in the context of their lives, and (iii) shift into different motivational patterns that are orientated around safeness and compassion. Voice-hearers are supported to engage with biopsychosocial components of compassionate mind training, which are briefly summarized, and to cultivate an embodied sense of a compassionate self-identity. They are invited to consider, and practice, how they might wish to relate to themselves, their voices, and other people, from the position of their compassionate self. This paper proposes, in line with the broader science of compassion and CFT, that repeated practice of creating internal patterns of safeness and compassion can provide an optimum biopsychosocial environment for affect-regulation, emotional conflict-resolution, and therapeutic change. Examples of specific therapeutic techniques, such as chair-work and talking with voices, are described to illustrate how these might be incorporated in one-to-one sessions of CFT.

Project description:BACKGROUND:Depersonalisation is the experience of being detached or disconnected from one's experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically significant depersonalisation in such patient groups. This study aims to determine the feasibility and acceptability of a brief intervention targeting clinically significant depersonalisation in those who also have current psychotic symptoms. METHODS/DESIGN:The feasibility of delivering six sessions of cognitive behavioural therapy for depersonalisation in psychosis patients will be evaluated using a single-blinded randomised controlled trial with a treatment as usual control condition. Participants will be assessed at baseline and then randomised to either the treatment or control arm. Participants randomised to the treatment arm will be offered six sessions of individual cognitive behavioural therapy delivered over a maximum of 10 weeks. Therapy will focus on an individualised shared formulation of depersonalisation experiences and behavioural, cognitive, emotional regulation and thinking process strategies to decrease distress associated with depersonalisation. Participants will be assessed again at a 10-week (post-randomisation) follow-up assessment. The primary outcomes of interest will be those assessing the feasibility and acceptability of the intervention including rates of referral, eligibility and acceptance to participate; attendance at therapy sessions and completion of homework tasks; satisfaction with the intervention; maintenance of blinding; and therapist competence. Secondary outcomes will be data on clinical outcome measures of depersonalisation and positive symptoms of psychosis, anxiety, depression and post-traumatic stress. DISCUSSION:This study will determine the feasibility of delivering six sessions of cognitive behavioural therapy for individuals with current psychotic symptoms who also experience clinically significant levels of depersonalisation. The results will provide information to inform a larger randomised trial to assess intervention efficacy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02427542.

Dataset Information

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).

Background

Methods

Discussion

Trial registration

Publications

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).

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