Clinical trial NCT02162030: A Component Analysis of Acceptance and Commitment Therapy
Official title: The Impact of Self as Context in the Treatment of Long-term Health Conditions With Acceptance and Commitment Therapy; a Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-term Physical Health Conditions
Mild to Moderate Anxiety and/or Depression
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Primary Care Health and Medical Psychology Services
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Daniel C Stockton
role: PRINCIPAL_INVESTIGATOR
References: