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临床试验/NCT03925259
NCT03925259已完成不适用

A Pilot Randomised Dismantling Trial of the Efficacy of Self-As-Context During Acceptance and Commitment Therapy

University of Sheffield2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in psychological flexibility abilities via the Acceptance and Action Questionnaire II (AAQ-II; Bond et al., 2011).

研究概览

简要总结

The six processes within the psychological flexibility model of acceptance and commitment therapy (ACT) are seen as being equally theoretically and clinically important. The utility of self-as-context component however has never been isolated in a dismantling study. The present study therefore sought to conduct a pilot two-arm dismantling component study of ACT, quarantining the self-as-context component from one of the arms. Patients with a long-term health condition (LTC) and concurrent mental health condition were randomised into one of two study arms; (1) Full-ACT or (2) ACT minus self-as-context (ACT-SAC). Participants in each arm were compared with regards to their ability to engage in psychological flexibility and decentering. Clinical outcomes were compared at end of treatment and also at 6-weeks follow-up.

详细描述

Acceptance and commitment therapy (ACT) is a 'third wave' behaviour therapy that has been building an evidence base to suggest that it is a promising and useful psychotherapy across a wide range of diagnoses (for reviews see Hayes, Luoma, Bond, Masuda, & Lillis, 2006; Powers, Zum, & Emmelkamp, 2009; Ruiz, 2010; Öst. 2014). ACT is grounded in relational frame theory (RFT; Hayes, 2004) and seeks to define how patients become overly emotionally influenced by internal dialogues, to the point of being immune to positive environmental contingencies (Ciarrochi, Bilich, & Godsel, 2010). The main aim of ACT is to enable psychological flexibility, so that a patient is able to fully connect to the present moment and to also alter (or continue with) behaviours closely aligned to personal values (Hayes et al., 1999). The goal of ACT is to teach skills of handling unwanted/avoided thoughts/feelings to reduce their impact/influence and clarifying what is truly important and meaningful, then using that knowledge to guide, inspire, and motivate continued valued actions in the effort to enrich personal lives (Hayes, 2004).

Psychological flexibility is achieved through six core processes during ACT; defusion; acceptance; contact with the present moment; values; committed action and self-as-context (Hayes, Strosahl, & Wilson, 2012). These components are combined in the 'hexaflex' model (Rolffs, Rogge & Wilson, 2018). Strosahl, Hayes,Wilson, and Gifford (2004) however stated that there was clinically no predefined order for focusing on the processes and not all individuals needed to concentrate on each of the processes to achieve flexibility. There are a variety of in-session and between-session exercises for each aspect of the hexaflex that support patients in understanding, practicing and using the relevant psychological skills (e.g. Hayes et al., 1999).

The ACT model discriminates between three aspects or levels of self; self-as-content, self-as-process, and self-as-context (Hayes et al., 2012). Self-as-content refers to the contents of psychological experience, self-as-process refers to awareness of the on-going changing nature of experiences and self-as-context refers to experiential contact with a persistent and unchanging perspective from which all experiences are observed (De Houwer, Roche, & Dymond, 2013). During ACT, patients learn to build awareness of self-as-context, whilst simultaneously letting go of any over-attachment to a conceptualised self. Self-as-context is independent of content and is the place from which content is observed (Ciarrochi, et al., 2010). The 'I' of self-as-context statements is learnt to be appreciated as stable/constant, in order to retain a sense of self in the face of stress (Pierson et al., 2004) and to appreciate that self-evaluations are transient and temporary (Hayes et al., 1999). Hayes et al (2012) postulated that the ability to occupy a self-as-context position requires self-as-process to be learnt first

The last several decades of psychotherapy outcome research have mainly focussed on gauging the efficacy of 'complete' psychotherapies (i.e. the 'package' of treatment). Whilst this approach has proved useful in some psychotherapies being then recognized as empirically validated, it has simultaneously failed to identify which aspects of the package that are essential, redundant or possibly harmful (Rosen & Davison, 2003). This 'package approach' has also been criticised for promoting the proliferation of apparently 'new' psychotherapies that are essentially re-packages of extant psychotherapies (Ciarrochi et al., 2010). Therefore, despite extensive outcome research validating psychotherapy as an effective treatment (e.g. Roth & Fonagy, 2006), research has been slower to identify the necessary, effective and active ingredients of each individual psychotherapy. Therefore, proving the utility of these different active ingredients (and associated definitive technical features) is a key challenge to the psychotherapy outcome literature (Crits-Christoph, 1997; Stevens, Hynan, & Allen, 2000). Research is therefore necessary that unpacks and compares the components of any psychotherapy 'package' to then assess their relative and specific contribution to outcomes (Stevens et al., 2000).

Two methodological approaches have been previously used to dismantle, isolate and define the importance of specific components within ACT's hexaflex; mediation studies and lab-based component analyses. Mediation analyses index changes in putative processes between treatments, and so identifies the clinical utility of theoretically distinct components (Kraemer, Wilson, Fairburn, & Agras, 2002). However, only a small number of core ACT processes have been examined in mediation studies (namely acceptance and cognitive defusion; see Stockton et al., 2019 for a recent review). Lab-based studies have compared performance on tasks when participants are provided with instructions grounded in a component of the hexaflex (or 'control' instructions) and a meta-analysis has shown small-to-medium effect sizes for 4/6 hexaflex components (Levin, Hildebrandt, Lillis, & Hayes, 2012). No lab-based studies have been conducted on the committed action or self-as-context components (Levin, Hildebrandt, Lillis, & Hayes, 2012). The clinical trial design used to test the efficacy of components of psychotherapies are labelled as either a deconstruction or an additive study (Ahn & Wampold. 2001). Dismantling designs compare a whole treatment, with treatment minus a specific theoretically important component (e.g. Jacobson et al., 1996). Additive designs test the impact of providing a specific and supplementary component hypothesised to enhance outcomes (e.g. Propst, Ostrom, Watkins, Dean, & Mashburn, 1992). No clinical dismantling trials of ACT's hexaflex have been attempted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The participants were masked as to their allocation to either full treatment or treatment with the self-as-context component removed.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Long term physical health condition and comorbid mental health problem
  • Referred to a psychological therapies service

排除标准

  • Diagnosis of 'medically unexplained symptoms' including somatoform disorders (e.g. pain disorder, conversion disorder, body dysmorphic disorder, hypochondriasis) and functional somatic syndromes (e.g. irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, non-cardiac chest pain, non-epileptic seizures)
  • Mental health diagnoses in addition to anxiety or depression (e.g. personality disorder, bipolar disorder or psychosis)
  • Currently accesses secondary care mental health services
  • Significant current suicidal risk
  • Current substance misuse
  • Previous contact with mental health services (defined as two or more prior episodes of service contact without significant change)
  • Inpatient admission for mental health difficulties within the last five years
  • History of self-injury
  • A stated reluctance to engage in psychotherapy.

研究组 & 干预措施

Full-ACT

Active Comparator

Participants received eight 50-minute sessions of ACT. A treatment protocol comprising of eight modules in the Full-ACT arm was developed by the research team. Each module comprised a series of exercises and metaphors, as well as guidance on how to discuss specific components. There was some degree of flexibility by which therapists introduced modules (Strosahl et al., 2004). However, by the final session, all eight mandatory subjects, exercises, and metaphors had to be covered. Modules were as follows: creative hopelessness; acceptance; defusion; present-momentness; self-as-context; values; and committed action.

干预措施: Acceptance and Commitment Therapy (Behavioral)

ACT-SAC

Experimental

Participants received eight 50-minute sessions of ACT. A treatment protocol comprising of seven modules in the ACT-SAC arm was developed by the research team. Each module comprised a series of exercises and metaphors, as well as guidance on how to discuss specific components. There was some degree of flexibility by which therapists introduced modules (Strosahl et al., 2004). However, by the final session, all mandatory subjects, exercises, and metaphors had to be covered. Modules were as follows: creative hopelessness; acceptance; defusion; present-momentness; values; and committed action.

The ACT-SAC condition removed the self-as-context module; therapists were instructed to avoid any reference to self-as-context or to support discussions regarding this process.

干预措施: Acceptance and Commitment Therapy (Behavioral)

结局指标

主要结局

Change in psychological flexibility abilities via the Acceptance and Action Questionnaire II (AAQ-II; Bond et al., 2011).

时间窗: AAQ-II (flexibility) scores compared in the arms at final therapy session and at 6-week follow-up

The AAQ-II is a 7-item measure of psychological inflexibility (score range 7-49) and is based on the widely researched Acceptance and Action Questionnaire (Hayes et al., 2004). The AAQ-II has sound psychometric properties (Bond et al., 2011).

次要结局

  • Change in decentering abilities via the Experiences Questionnaire (EQ; Fresco, Moore, van Dulmen, Segal, Teasdale, Ma, & Williams, 2007).(EQ (decentering) scores compared in the arms at final therapy session and at 6-week follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Kellett

IAPT Programme Director

University of Sheffield

研究点 (2)

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