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

NCT03925259 | Completed DMC

• 1 other identifier: 144363
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression, Anxiety

Keywords

ACT; dismantling; long term conditions

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• Change in functioning via the Work and Social Adjustment Scale (WSAS; Mundt, Marks, Shear, & Greist, 2002).

  WSAS (functioning) scores compared in the arms at final therapy session and at 6-week follow-up

• Changes to depression via The Patient Health Questionnaire (PHQ9; Spitzer, Kroenke & Williams; 1999)

  PHQ-9 (depresion) scores compared in the arms at final therapy session and at 6-week follow-up

• Chnages to anxiety via The Generalised Anxiety Disorder Assessment (GAD7; Spitzer, Kroenke, Williams & Lowe; 2006).

  GAD-7 (anxiety) scores compared in the arms at final therapy session and at 6-week follow-up

Study Arms (2)

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.

Behavioral: Acceptance and Commitment Therapy

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.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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

ACT-SAC; Full-ACT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

Clinical Psychology Unit, Department of Psychology, Uni of Sheffield

Sheffield, Yorkshire, S10 2TN, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrew Thompson, D Clin Psy

  Director of Research: Clinical Psychology Unit: University of Sheffield

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were masked as to their allocation to either full treatment or treatment with the self-as-context component removed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IAPT Programme Director

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 24, 2019
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This has been completed
• Access Criteria: Other clinical researchers with a validated email address.

Locations

GB (1)