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Depression, AnxietyNCT03925259

Dismantling the Efficacy of Self-As-Context During Acceptance and Commitment Therapy

A study testing Acceptance and Commitment Therapy in people with Depression, Anxiety, run by University of Sheffield at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
1 Jan 2012to 1 Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Long term physical health condition and comorbid mental health problem
  • Age 16+
  • Referred to a psychological therapies service

Who cannot join

  • 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)
Show all 9Show fewer
  • Inpatient admission for mental health difficulties within the last five years
  • History of self-injury
  • A stated reluctance to engage in psychotherapy.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Clinical Psychology Unit, Department of Psychology, Uni of Sheffield

    Sheffield, Yorkshire, S10 2TN

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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.

RFT provides the theoretical basis for the importance of self-as-context as a component of the hexaflex, as this component is believed to enable and facilitate engagement with the other core processes of the hexaflex (Hayes, 2004). There is however an on-going debate as to whether development of self-as-context is necessary during ACT to enable flexibility, or whether it is sufficient to only develop self-as-process (De Houwer et al., 2013; McHugh \& Stewart, 2012). This is the first study to use a deconstruction method to examine the efficacy of the self-as-context component of the psychological flexibility model. Given that the ethical and therapeutic impact of extracting a potentially clinically important hexaflex component has been previously untested, the current study adopted a pilot trial approach. The scientific value of pilot studies that examine the feasibility, safety and effectiveness of new treatments (or in the current context, a deconstructed partial treatment) is widely recognised (Arain, Campbell, Cooper \& Lancaster, 2010). The study used participants with a long-term health condition (LTC) and concurrent mental health problems, in terms of their ability to engage in psychological flexibility, decentering and also clinical outcome. Patients with LTCs were seen as an appropriate patient group for the present study, as previous evidence has attested to the effectiveness of ACT with this patient group (Levin et al., 2012). The hypotheses for the study were that participants receiving full ACT would (a) display enhanced ability to engage in psychological flexibility and decentering and (b) achieve better clinical outcomes.

Being tested
Acceptance and Commitment Therapy
Keywords
ACT, dismantling, long term conditions
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    Acceptance and commitment therapy (ACT) is a 'third wave' behaviour therapy delivered on a one to one basis.

Study groups in NCT03925259
Study groupRoleWhat they receive
Full-ACTActive comparatorParticipants 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.
Receives: Behavioral: Acceptance and Commitment Therapy
ACT-SACExperimentalParticipants 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.
Receives: Behavioral: Acceptance and Commitment Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

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

Secondary outcomes (1)
  1. Change in decentering abilities via the Experiences Questionnaire (EQ; Fresco, Moore, van Dulmen, Segal, Teasdale, Ma, & Williams, 2007).

    The EQ is a 20-item measure of decentering and rumination. Only the EQ-decentering scale was used in the current study; this contains 11-items and so scores ranged from 11-55. The EQ has been shown to have good convergent, discriminant and internal consistency (Fresco, et al., 2007). The EQ-decentering scale has been cross-culturally validated and can detect changes in decentering abilities after mindfulness-based interventions (Soler et al., 2017).

    Measured: EQ (decentering) scores compared in the arms at final therapy session and at 6-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start1 Jan 2012
  3. Primary completion1 Jan 2013
  4. Study completion1 Jun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design was a pilot, randomised and controlled dismantling trial. Ethical approval was granted to conduct the trial (ref: 144363) and was contingent on adverse events being monitored in the arms. Participants were randomised to either full-ACT (i.e. the full hexaflex approach) or ACT-SAC (i.e. ACT minus the self-as-context component of the hexaflex). Participants were blind to their allocation. ACT process measures were completed at assessment, final therapy session and at 6-week follow-up and the outcome measures were taken on a session-by-session basis and at 6-week follow-up.
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925259
Sponsor's protocol ID
144363
Status last verified
Apr 2019
First submitted
18 Apr 2019
Last updated
24 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This will be made apparent in any publication

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Depression, Anxiety, run by University of Sheffield at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in psychological flexibility abilities via the Acceptance and Action Questionnaire II (AAQ-II; Bond et al., 2011). (time frame: AAQ-II (flexibility) scores compared in the arms at final therapy session and at 6-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.

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