Long-term Physical Health ConditionsNCT02162030
A Component Analysis of Acceptance and Commitment Therapy
A study testing Acceptance and Commitment Therapy in people with Long-term Physical Health Conditions and Mild to Moderate Anxiety and/or Depression, run by University of Sheffield at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long-term Physical Health Conditions, Mild to Moderate Anxiety and/or Depression
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 9Show fewer
- Inpatient admission for mental health difficulties within the last five years
- History of overdoses or other self-injury
- Stated reluctance to engage in psychotherapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Primary Care Health and Medical Psychology Services
Sheffield, South Yorkshire, S10 3TH
About this study
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
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.
- Being tested
- Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Full ACT | Other | Acceptance and Commitment Therapy Receives: Behavioral: Acceptance and Commitment Therapy |
| Modified ACT | Other | Acceptance and Commitment Therapy Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Physical Health ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Stockton, University of Sheffield
- Investigators
- Daniel C Stockton, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162030
- Sponsor's protocol ID
- 139593
- Status last verified
- Feb 2018
- First submitted
- 6 Jun 2014
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02162030
- Acronym / sponsor ID
- 139593
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full ACT | Other | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy |
| Modified ACT | Other | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyHalf 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. | Behavioural | Full ACT, Modified ACT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Stockton principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Long-term Physical Health Conditions and Mild to Moderate Anxiety and/or Depression, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.