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A Component Analysis of Acceptance and Commitment Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162030
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Stockton, University of Sheffield

Tracking Information
First Submitted Date  ICMJE June 6, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date February 9, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Change from baseline psychological flexibility at end of 8-session psychological intervention (approximately 8 weeks) and at post-therapy eight week follow-up (using the Acceptance and Action Questionnaire II) [ Time Frame: Measure taken at first therapy appointment (baseline), taken again after 8-session intervention (approximately 8 weeks) and again at eight week post-therapy follow-up ]
    The Acceptance and Action Questionnaire II (Bond et al., 2011) is a 10-item self-report questionnaire measuring psychological flexibility on a 7-point likert scale
  • Change from baseline self-report 'quality of life' at end of 8-session psychological intervention (approximately 8 weeks) and at post-therapy eight week follow-up (using the Work and Social Adjustment Scale) [ Time Frame: Measure taken at first therapy appointment (baseline), taken again after 8-session intervention (approximately 8 weeks) and again at eight week post-therapy follow-up ]
    The Work and Social Adjustment Scale (Mundt, Marks, Shear, & Greist, 2002) is a 5-item self-report questionnaire measuring functional impairment and disability attributable to the effects of a health condition using a 9-point likert scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Component Analysis of Acceptance and Commitment Therapy
Official Title  ICMJE The Impact of Self as Context in the Treatment of Long-term Health Conditions With Acceptance and Commitment Therapy; a Feasibility Pilot Study
Brief Summary The purpose of this study is to determine whether a specific component of Acceptance and Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this therapeutic approach.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Long-term Physical Health Conditions
  • Mild to Moderate Anxiety and/or Depression
Intervention  ICMJE Behavioral: Acceptance and Commitment Therapy
Half of the participants will receive an eight-session ACT intervention whereby each component of the psychological flexibility model will be covered. Half of the participants will receive an eight-session act intervention whereby each component except self as context will be covered.
Study Arms  ICMJE
  • Full ACT
    Acceptance and Commitment Therapy
    Intervention: Behavioral: Acceptance and Commitment Therapy
  • Modified ACT
    Acceptance and Commitment Therapy
    Intervention: Behavioral: Acceptance and Commitment Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2014)
24
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults of working age (18-65)
  • Patients with a primary positive diagnosis of a long-term health condition (The most common conditions referred to the service are Diabetes, Chronic Obstructive Pulmonary Disease [COPD], Rheumatoid Arthritis and Epilepsy) where there is a verifiable medical diagnosis supported by the patients General Practitioner (GP) and/or secondary care physician
  • Patients with concurrent mental health difficulties (defined as mild - moderate anxiety and/or depression, see table one).

Exclusion Criteria:

  • Patients with a primary diagnosis of 'medically unexplained symptoms' (MUS) 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 mild - moderate anxiety / depression (e.g. personality disorder, bipolar disorder, psychosis etc.)
  • Patients in receipt of secondary care mental health services
  • Patients with severe and enduring mental health difficulties
  • Significant risk issues, or current substance misuse
  • Previous contact with mental health services (defined as two or more prior episodes of contact without significant change)
  • Inpatient admission for mental health difficulties within the last five years
  • History of overdoses or other self-injury
  • Stated reluctance to engage in psychotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162030
Other Study ID Numbers  ICMJE 139593
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Stockton, University of Sheffield
Study Sponsor  ICMJE University of Sheffield
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel C Stockton University of Sheffield
PRS Account University of Sheffield
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP