CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE) (PRINCE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02426788 |
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Recruitment Status :
Completed
First Posted : April 27, 2015
Last Update Posted : May 9, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Persistent Physical Symptoms (PPS) | Behavioral: Cognitive behavioural therapy (CBT) | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 324 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care |
| Study Start Date : | July 2015 |
| Actual Primary Completion Date : | January 2019 |
| Actual Study Completion Date : | January 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CBT+SMC
Cognitive behavioural therapy + Standard Medical Care (cognitive-behavioural therapy+SMC): 8 hour-long manual-based CBT sessions with a therapist, weekly or fortnightly. |
Behavioral: Cognitive behavioural therapy (CBT)
Behavioral: Cognitive behavioural therapy (CBT) The CBT intervention used in the trial has been adapted for people with PPS and it is based on a model of understanding PPS (Deary et al 2007). The therapy aims to help the patient develop an understanding of the relationship between cognitive, physiological and behavioural aspects of their problem; to understand factors that may be maintaining the problem and to learn how to modify their behavioural and cognitive responses in order to improve quality of life. The approach is transdiagnostic in that it targets processes and underlying mechanisms that affect disorders similarly, rather than focusing on how they are diagnostically different. The approach is personalised during therapy following a detailed assessment. |
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No Intervention: Standard Medical Care (SMC)
Participants assigned to the SMC group (i.e., control group) will receive all the treatment and support they would otherwise receive outside of a research trial.
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- Work and social adjustment scale [ Time Frame: 52 weeks post randomisation ]Measures impairment in functioning
- Persistent Physical Symptom Questionnaire [ Time Frame: 52 weeks post randomisation ]Measures severity, distress, interference and problematic nature of PPS
- Patient Health Questionnaire-15 (PHQ-15) [ Time Frame: 52 weeks post randomisation ]Measures physical symptoms severity
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 52 weeks post randomisation ]Measures mood
- Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 52 weeks post randomisation ]Measures generalised anxiety
- Clinical Global Impression (CGI) [ Time Frame: 52 weeks post randomisation ]Measures patient's perception of their general health improvement
- Client Service Receipt Inventory (CSRI) [ Time Frame: 52 weeks post randomisation ]Measures health care service receipt, direct and indirect costs of illness, and cost-effectiveness of interventions
- EuroQol-5D (EQ-5D) [ Time Frame: 52 weeks post randomisation ]Measures health outcome
- Cognitive Behavioural Responses Questionnaire [ Time Frame: 52 weeks post randomisation ]Measures beliefs and behaviours
- Acceptance scale [ Time Frame: 52 weeks post randomisation ]assesses degree of acceptance of difficult symptoms
- PSYCHLOPS [ Time Frame: 52 weeks post randomisation ]Measures improvement of patient-defined self-rated problems
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- Adults (18 - 70 yrs)
- Patients with PPS from broad patient populations (e.g., fibromyalgia, non-cardiac chest pain, postural orthostatic tachycardia syndrome, neurological symptoms);
- Significant functional impairment/moderately severe disability - as indicated by the Work and Social Adjustment Scale (WSAS) score (i.e., a minimum score of 10);
- Ability to complete diaries and questionnaires in English;
- Willingness to complete all trial visits;
- Ability to give written informed consent.
Exclusion Criteria:
- Active psychosis;
- Factitious disorder;
- Headaches as the only PPS;
- Non-epileptic seizures
- Current alcohol dependence or drug addiction as assessed by the clinician;
- Current benzodiazepine use exceeding the equivalent of 10mg diazepam/day;
- The patient is currently receiving CBT/CBT based approach psychotherapy, or has received CBT/CBT based approach psychotherapy in the past year, for their PPS;
- The patient is thought to be at imminent risk of self-harm;
- Patient is taking part in PRINCE Primary trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426788
| United Kingdom | |
| Guy's Hospital | |
| London, United Kingdom | |
| King's College Hospital | |
| London, United Kingdom | |
| Queen Elizabeth Hospital | |
| London, United Kingdom | |
| Royal Free Hospital | |
| London, United Kingdom | |
| St Thomas' Hospital | |
| London, United Kingdom | |
| University Hospital Lewisham | |
| London, United Kingdom | |
| Princess Royal University Hospital | |
| Orpington, United Kingdom | |
| Principal Investigator: | Trudie Chalder, PhD | King's College London |
| Responsible Party: | King's College London |
| ClinicalTrials.gov Identifier: | NCT02426788 |
| Other Study ID Numbers: |
STR130202 (Secondary) |
| First Posted: | April 27, 2015 Key Record Dates |
| Last Update Posted: | May 9, 2019 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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medically unexplained fibromyalgia postural orthostatic tachycardia syndrome (PoTs) non-cardiac chest pain CFS |
irritable bowel syndrome (IBS) functional neurological chronic pain hyperventilation unexplained cough |
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Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |

