NCT02162030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

June 6, 2014

Last Update Submit

February 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    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

  • 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)

    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

    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

Study Arms (2)

Full ACT

OTHER

Acceptance and Commitment Therapy

Behavioral: Acceptance and Commitment Therapy

Modified ACT

OTHER

Acceptance and Commitment Therapy

Behavioral: Acceptance and Commitment Therapy

Interventions

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.

Full ACTModified ACT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Health and Medical Psychology Services

Sheffield, South Yorkshire, S10 3TH, United Kingdom

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daniel C Stockton

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 12, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations