Persistent Physical SymptomsPRINCE PrimaryNCT02444520
PRINCE Primary: Integrated GP Care for Persistent Physical Symptoms - a Feasibility & Cluster Randomised Controlled Trial
A study testing Integrated GP Care in people with Persistent Physical Symptoms, run by King's College London at 1 site in United Kingdom.
Trial summary
PRINCE primary is cluster randomised waiting list controlled trial to evaluate the feasibility of an integrated approach to care in general practice for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying organic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Physical Symptoms
- What is being tested?
- Integrated GP Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Jan 2018
- 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
Patients that fit the eligibility criteria will be invited to take part in the study. Patients will be considered eligible for inclusion in this study if they fulfil all of the following criteria:
(i) have a PPS diagnosis (which are medically unexplained) (ii) are greater than or equal to 18 and less than or equal to 65 years old (iii) are registered with a GP practice in South London that has consented to taking part in PRINCE Primary (iv) have had 6 or more consultations in the last year (not necessarily for the same symptom or directly related to PPS (v) have given written informed consent, provided baseline data before randomisation and can speak and read English at a level adequate for participation in the.
Patients will be excluded from the study if the patient has:
(i) active psychosis (ii) drug or alcohol addiction as indicated in the patient's medical notes (iii) current benzodiazepine use exceeding the equivalent of 10mg diazepam per day (iv) had any psychotherapy treatment within the last year (not inclusive of general visits from community psychiatric teams) (v) dissociative seizures (vi) if they are at imminent risk of self-harm, after psychiatric/ psychological assessment (vii) taking part in the PRINCE Secondary study or the ACTIB Study (Everitt et al., 2015).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Physical Symptoms Reduction Intervention: a Systems Change and Evaluation (PRINCE) - Integrated GP Care for Persistent Physical Symptoms: a Feasibility & Cluster Randomised Controlled Trial
PRINCE primary is cluster randomised waiting list controlled trial to evaluate the feasibility of an integrated approach to care in general practice for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying organic. 240 patients with PPS recruited from 8-12 GP practices in London will be randomised to the integrated care approach plus treatment as usual (TAU) or TAU alone. The integrated GP approach consists of providing GPs with a short cognitive behaviour therapy (CBT) skills training, ongoing supervision, as well as written and audio-visual materials/guidelines. In addition, participants randomised to the intervention group will receive tailored CBT-based self-help materials (i.e. written and audio-visual materials).
Read the detailed description
Patients with PPS are often severely functionally impaired and. They consume large amounts of healthcare and welfare benefits. There is an accumulating body of evidence showing that cognitive behavioural interventions can reduce levels of symptoms and improve overall functioning in patients with PPS. CBT has demonstrated both short-term and long-term efficacy with small to medium effect sizes for PPS. Larger treatment effects have been reported for specific PPS syndromes, including non-cardiac chest pain, Irritable Bowel Syndrome (IBS), and Chronic Fatigue Syndrome (CFS).
General practitioners (GPs) play a major role in identifying and managing patients with PPS. A previous randomised parallel group pilot trial investigated the feasibility (i.e. recruitment, retention and acceptability) of implementing a primary care Symptoms Clinic for patients with PPS). The Symptoms Clinic comprised a structured set of consultations delivered by a specially trained GP with a strong interest in PPS. The intervention included exploring potential biological mechanisms underlying the PPS condition, empathetic support, and training patients in symptom-management (i.e. medication or cognitive behavioural techniques). The results indicated that the Symptoms Clinic was acceptable to the majority of patients randomised to the intervention group, and may have the potential to generate clinically significant benefits. However, this pilot study did not assess feasibility parameters referring to GPs' willingness to participate in the study and undergo specialised psychological training. Moreover, the intervention was carried out by only one GP, raising questions about the generalizability of the study.
Managing patients with PPS can be highly challenging in general practice. Although GPs recognise the treatment of PPS as a responsibility of primary care, previous studies show that GPs often feel powerless, frustrated and helpless when encountering these patients. Furthermore, GPs frequently report that factors such as time constraints and the lack of psychological training prevents them from effectively addressing patients' psychosocial needs and developing appropriate doctor-patient communication skills.
The aim of this study is to assess whether it is feasible to conduct an adequately powered future trial to evaluate the efficacy and cost-effectiveness of a CBT-based integrated GP care approach for treating patients with PPS (please refer to arms and interventions for more details).
- Conditions
- Persistent Physical Symptoms
- Being tested
- Integrated GP Care
- Keywords
- Medically unexplained symptoms, Primary care, Cognitive behaviour therapy skills, Cluster randomised controlled trial, Feasibility
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated GP CareBehavioural
The overall aims of the intervention are to help the patient:
- develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem;
- understand factors that may be maintaining the problem;
- learn how to modify the behavioral and cognitive responses which may be maintaining the problem;
- adopt a healthy sleep routine which can promote healthy living.
Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed.
| Study group | Role | What they receive |
|---|---|---|
| Integrated GP Care | Experimental | * GP training in utilising cognitive behavioural skills during 10-minute consultations;
* GP Supervision;
* Audio-visual and written materials/guidelines for GP's;
* Copies of self-help materials for patients;• Integrated case management discussion prior to secondary care referral. GPs will be encouraged to consult with a colleague before making a referral;
* Booklets for patients once consent gained. Receives: Behavioral: Integrated GP Care |
| Waiting List Control Group | No intervention | Patients in the waiting list control group will continue to receive treatment as usual (TAU), and will be crossed over to receive 'Integrated GP Care' at 6 months post randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Willingness of clinicians to participate in the study (proportion of GPs that register within the study out of the GPs that are registered with the eligible practice)
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Willingness of patients to use the provided material given in 'integrated GP care' (self-help material).
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Willingness of practices and participants to be contacted about the study (Number (No.) of reply slips sent via the post to ask if the practice/participants would like to participate further information v No. of reply slips received back)
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Willingness of practices to be randomised (No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent)
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Willingness of GP practices to be consent and be randomized as assessed by No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Follow-up rates and response rates to questionnaires (Sent questionnaires v completed questionnaires received at 12 and 24 weeks).
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Rate of eligible trial participants (Consort). The number of patients per practice that are initially screened for eligibility and the number per practice meeting the inclusion and exclusion criteria.
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Availability of data required and the usefulness and limitations of GP databases assessed qualitatively
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Feasibility: Willingness of participants to be consented and randomised (No. of positive reply slips received V No. of patients agreed to be screened, No. of eligible patients agreed consent v No. of eligible patients not agreed to consent)
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Measured: 24 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Persistent Physical SymptomsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- PRINCE Primary is a cluster randomised waiting list controlled trial to evaluate the acceptability and feasibility of an integrated approach to care in general practice for adults with PPS.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Trudie Chader, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444520
- Sponsor's protocol ID
- STR130202 (Primary)
- Acronym
- PRINCE Primary
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2015
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
PubMed 11914441Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PubMed 10158943Kleinstauber M, Witthoft M, Hiller W. Efficacy of short-term psychotherapy for multiple medically unexplained physical symptoms: a meta-analysis. Clin Psychol Rev. 2011 Feb;31(1):146-60. doi: 10.1016/j.cpr.2010.09.001. Epub 2010 Sep 16.
PubMed 20920834Nimnuan C, Hotopf M, Wessely S. Medically unexplained symptoms: an epidemiological study in seven specialities. J Psychosom Res. 2001 Jul;51(1):361-7. doi: 10.1016/s0022-3999(01)00223-9.
PubMed 11448704Sharpe M, Stone J, Hibberd C, Warlow C, Duncan R, Coleman R, Roberts R, Cull R, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Smyth R, Walker A, Walker J, MacMahon A, Murray G, Carson A. Neurology out-patients with symptoms unexplained by disease: illness beliefs and financial benefits predict 1-year outcome. Psychol Med. 2010 Apr;40(4):689-98. doi: 10.1017/S0033291709990717. Epub 2009 Jul 23.
PubMed 19627646Altayar O, Sharma V, Prokop LJ, Sood A, Murad MH. Psychological therapies in patients with irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. Gastroenterol Res Pract. 2015;2015:549308. doi: 10.1155/2015/549308. Epub 2015 Jan 31.
PubMed 25802514Burton C, Weller D, Marsden W, Worth A, Sharpe M. A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial. BMJ Open. 2012 Feb 9;2(1):e000513. doi: 10.1136/bmjopen-2011-000513. Print 2012.
PubMed 22327629Johansen ML, Risor MB. What is the problem with medically unexplained symptoms for GPs? A meta-synthesis of qualitative studies. Patient Educ Couns. 2017 Apr;100(4):647-654. doi: 10.1016/j.pec.2016.11.015. Epub 2016 Nov 21.
PubMed 27894609Jonsbu E, Dammen T, Morken G, Moum T, Martinsen EW. Short-term cognitive behavioral therapy for non-cardiac chest pain and benign palpitations: a randomized controlled trial. J Psychosom Res. 2011 Feb;70(2):117-23. doi: 10.1016/j.jpsychores.2010.09.013. Epub 2010 Dec 3.
PubMed 21262413Kennedy TM, Chalder T, McCrone P, Darnley S, Knapp M, Jones RH, Wessely S. Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial. Health Technol Assess. 2006 Jun;10(19):iii-iv, ix-x, 1-67. doi: 10.3310/hta10190.
PubMed 16729918Kisely SR, Campbell LA, Skerritt P, Yelland MJ. Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004101. doi: 10.1002/14651858.CD004101.pub3.
PubMed 20091559Moss-Morris R, Chalder T. Illness perceptions and levels of disability in patients with chronic fatigue syndrome and rheumatoid arthritis. J Psychosom Res. 2003 Oct;55(4):305-8. doi: 10.1016/s0022-3999(03)00013-8.
PubMed 14507540Salmon P, Peters S, Clifford R, Iredale W, Gask L, Rogers A, Dowrick C, Hughes J, Morriss R. Why do general practitioners decline training to improve management of medically unexplained symptoms? J Gen Intern Med. 2007 May;22(5):565-71. doi: 10.1007/s11606-006-0094-z.
PubMed 17443362
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Physical Symptoms Reduction Intervention: a Systems Change and Evaluation (PRINCE) - Integrated GP Care for Persistent Physical Symptoms: a Feasibility & Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02444520
- Acronym / sponsor ID
- PRINCE Primary / STR130202 (Primary)
- Conditions
- Persistent Physical Symptoms
- Keywords
- Medically unexplained symptoms, Primary care, Cognitive behaviour therapy skills, Cluster randomised controlled trial, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- May 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 May 2015 (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.
PRINCE primary is cluster randomised waiting list controlled trial to evaluate the feasibility of an integrated approach to care in general practice for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying organic. 240 patients with PPS recruited from 8-12 GP practices in London will be randomised to the integrated care approach plus treatment as usual (TAU) or TAU alone. The integrated GP approach consists of providing GPs with a short cognitive behaviour therapy (CBT) skills training, ongoing supervision, as well as written and audio-visual materials/guidelines. In addition, participants randomised to the intervention group will receive tailored CBT-based self-help materials (i.e. written and audio-visual materials).
Detailed description
Patients with PPS are often severely functionally impaired and. They consume large amounts of healthcare and welfare benefits. There is an accumulating body of evidence showing that cognitive behavioural interventions can reduce levels of symptoms and improve overall functioning in patients with PPS. CBT has demonstrated both short-term and long-term efficacy with small to medium effect sizes for PPS. Larger treatment effects have been reported for specific PPS syndromes, including non-cardiac chest pain, Irritable Bowel Syndrome (IBS), and Chronic Fatigue Syndrome (CFS).
General practitioners (GPs) play a major role in identifying and managing patients with PPS. A previous randomised parallel group pilot trial investigated the feasibility (i.e. recruitment, retention and acceptability) of implementing a primary care Symptoms Clinic for patients with PPS). The Symptoms Clinic comprised a structured set of consultations delivered by a specially trained GP with a strong interest in PPS. The intervention included exploring potential biological mechanisms underlying the PPS condition, empathetic support, and training patients in symptom-management (i.e. medication or cognitive behavioural techniques). The results indicated that the Symptoms Clinic was acceptable to the majority of patients randomised to the intervention group, and may have the potential to generate clinically significant benefits. However, this pilot study did not assess feasibility parameters referring to GPs' willingness to participate in the study and undergo specialised psychological training. Moreover, the intervention was carried out by only one GP, raising questions about the generalizability of the study.
Managing patients with PPS can be highly challenging in general practice. Although GPs recognise the treatment of PPS as a responsibility of primary care, previous studies show that GPs often feel powerless, frustrated and helpless when encountering these patients. Furthermore, GPs frequently report that factors such as time constraints and the lack of psychological training prevents them from effectively addressing patients' psychosocial needs and developing appropriate doctor-patient communication skills.
The aim of this study is to assess whether it is feasible to conduct an adequately powered future trial to evaluate the efficacy and cost-effectiveness of a CBT-based integrated GP care approach for treating patients with PPS (please refer to arms and interventions for more details).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- PRINCE Primary is a cluster randomised waiting list controlled trial to evaluate the acceptability and feasibility of an integrated approach to care in general practice for adults with PPS.
| Arm | Type | Receives |
|---|---|---|
| Integrated GP Care | Experimental | Behavioral: Integrated GP Care* GP training in utilising cognitive behavioural skills during 10-minute consultations; * GP Supervision; * Audio-visual and written materials/guidelines for GP's; * Copies of self-help materials for patients;• Integrated case management discussion prior to secondary care referral. GPs will be encouraged to consult with a colleague before making a referral; * Booklets for patients once consent gained. |
| Waiting List Control Group | No intervention | –Patients in the waiting list control group will continue to receive treatment as usual (TAU), and will be crossed over to receive 'Integrated GP Care' at 6 months post randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Integrated GP CareThe overall aims of the intervention are to help the patient: 1. develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem; 2. understand factors that may be maintaining the problem; 3. learn how to modify the behavioral and cognitive responses which may be maintaining the problem; 4. adopt a healthy sleep routine which can promote healthy living. Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed. | Behavioural | Integrated GP Care |
Primary outcome
Feasibility: Willingness of clinicians to participate in the study (proportion of GPs that register within the study out of the GPs that are registered with the eligible practice)
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Willingness of patients to use the provided material given in 'integrated GP care' (self-help material).
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Willingness of practices and participants to be contacted about the study (Number (No.) of reply slips sent via the post to ask if the practice/participants would like to participate further information v No. of reply slips received back)
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Willingness of practices to be randomised (No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent)
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Willingness of GP practices to be consent and be randomized as assessed by No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Follow-up rates and response rates to questionnaires (Sent questionnaires v completed questionnaires received at 12 and 24 weeks).
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Rate of eligible trial participants (Consort). The number of patients per practice that are initially screened for eligibility and the number per practice meeting the inclusion and exclusion criteria.
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Availability of data required and the usefulness and limitations of GP databases assessed qualitatively
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
Feasibility: Willingness of participants to be consented and randomised (No. of positive reply slips received V No. of patients agreed to be screened, No. of eligible patients agreed consent v No. of eligible patients not agreed to consent)
Time frame: 24 weeks post randomization
The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".
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 May 2019.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 11914441Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Background: PubMed 10158943Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
- Background: PubMed 20920834Kleinstauber M, Witthoft M, Hiller W. Efficacy of short-term psychotherapy for multiple medically unexplained physical symptoms: a meta-analysis. Clin Psychol Rev. 2011 Feb;31(1):146-60. doi: 10.1016/j.cpr.2010.09.001. Epub 2010 Sep 16.
- Background: PubMed 11448704Nimnuan C, Hotopf M, Wessely S. Medically unexplained symptoms: an epidemiological study in seven specialities. J Psychosom Res. 2001 Jul;51(1):361-7. doi: 10.1016/s0022-3999(01)00223-9.
- Background: PubMed 19627646Sharpe M, Stone J, Hibberd C, Warlow C, Duncan R, Coleman R, Roberts R, Cull R, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Smyth R, Walker A, Walker J, MacMahon A, Murray G, Carson A. Neurology out-patients with symptoms unexplained by disease: illness beliefs and financial benefits predict 1-year outcome. Psychol Med. 2010 Apr;40(4):689-98. doi: 10.1017/S0033291709990717. Epub 2009 Jul 23.
- Background: PubMed 25802514Altayar O, Sharma V, Prokop LJ, Sood A, Murad MH. Psychological therapies in patients with irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. Gastroenterol Res Pract. 2015;2015:549308. doi: 10.1155/2015/549308. Epub 2015 Jan 31.
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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.
Trudie Chader, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated GP Care in people with Persistent Physical Symptoms, run by King's College London 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?
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 May 2019. 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?
Feasibility: Willingness of clinicians to participate in the study (proportion of GPs that register within the study out of the GPs that are registered with the eligible practice) (time frame: 24 weeks post randomization). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444520, which also lists 23 linked publications.
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 May 2019.