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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02162030
Other study ID # 139593
Secondary ID
Status Completed
Phase N/A
First received June 6, 2014
Last updated February 8, 2018
Start date October 2014
Est. completion date June 2017

Study information

Verified date February 2018
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Disease
  • Long-term Physical Health Conditions
  • Mild to Moderate Anxiety and/or Depression

Intervention

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.

Locations

Country Name City State
United Kingdom Primary Care Health and Medical Psychology Services Sheffield South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06222346 - Online Peer Support in Long-term Conditions N/A