ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 30 for:    10109801 [PUBMED-IDS]

Helping Urgent Care Users Cope With Distress About Physical Complaints

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: NCT02298036
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.

To optimise the delivery of CBT for health anxiety delivered remotely by systematically identifying and then acting on barriers and enablers to the intervention through a network of practice.


Condition or disease Intervention/treatment Phase
Frequent Utilisers of Urgent Medical Care Who Have High Health Anxiety Behavioral: (Remote) Cognitive Behaviour Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Helping Urgent Care Users Cope With Distress About Physical Complaints: A Randomised Controlled Trial
Actual Study Start Date : January 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Remote Therapy Offered
Participants randomised to this arm receive 6-10 sessions of remote CBT
Behavioral: (Remote) Cognitive Behaviour Therapy
Randomised controlled trial of 6-10 sessions of CBT for health anxiety delivered remotely via video calling or the telephone versus treatment as usual. Treatment as usual will be that decided by the patient with their general practitioner and other health providers they consult for unscheduled/urgent care.

No Intervention: Treatment as Usual
Participants do not receive remote therapy and remain in usual care



Primary Outcome Measures :
  1. Health Anxiety Inventory: 14-Item Self Rated Short Form (Salkovskis 2002) [ Time Frame: Baseline to 6 months ]
    Self Rated


Secondary Outcome Measures :
  1. Health Anxiety Inventory: 14-Item Self Rated Short Form (Salkovskis 2002) [ Time Frame: Baseline to 12 months ]
    Self Rated

  2. Generalised Anxiety Disorder: 7 Item (Spitzer et al 2006) [ Time Frame: Baseline to 12 months ]
    Self Rated

  3. 9 item Patient Health Questionnaire for depression (PHQ-9; Kroenke et al, 2001). [ Time Frame: Baseline to 12 months ]
    Self Rated

  4. 8 item Work and Social Adjustment Scale for social function (WSAS; Mundt et al, 2002). [ Time Frame: Baseline to 12 months ]
    Self Rated

  5. 5 item quality of life on the EQ5D-5L (EuroQol Group, 1990) [ Time Frame: Baseline to 12 months ]
    Self Rated

  6. 36 item Short Form Health Survey (SF-36; Ware et al, 2000). [ Time Frame: Baseline to 12 months ]
    Self Rated

  7. Change in number of contacts with unscheduled or emergency care established through a totally adapted and stylised Client Service Receipt Inventory (CSRI; Beecham and Knapp 2001). [ Time Frame: Baseline to 12 months ]
    Self Rated



Information from the National Library of Medicine

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two or more consultations, referrals or hospital admissions with any provider of unscheduled or emergency care (including urgent same day appointment with own general practice) in the last 12 months for common presentations not attributed to identified pathology such as: cardiac e.g. chest pain, respiratory e.g. breathlessness, neurological e.g. dizziness, gastrointestinal e.g. abdominal pain or genitourinary e.g. pain on passing urine.
  • Scores above the threshold for severe health anxiety of 18 or more on the 14 item short version of the Health Anxiety Inventory (HAI; Salkovskis et al, 2002).
  • The participant is aged 18 or over.
  • Sufficient understanding of English (spoken and written).
  • They give oral and written informed consent to participate in the study.

Exclusion Criteria:

  • Pathological medical condition requiring further assessment or acute management, or pregnancy.
  • Other severe mental illness (schizophrenia, bipolar disorder, severe major depressive episode, eating disorder) ascertained by the Structured Clinical Interview for DSM-IV Disorders (SCID, Spitzer et al., 2002) or anyone at immediate risk of harm to themselves or other people through their mental state
  • Organic mental disorder (dementia, delirium, substance use disorder, organic mood disorder).
  • They are already receiving specialist mental health intervention, including psychological treatment as part of specialist medical care e.g. pain clinic.

All of the above require a different clinical approach to the treatments being tested in the study. Unipolar mild to moderate depressive episodes, other anxiety disorders or stable physical illness are not exclusions to the study as they are readily addressed by the intervention and are necessary to include if the study is pragmatic and going to generalise to clinical practice.


Information from the National Library of Medicine

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): NCT02298036


Locations
United Kingdom
Leicestershire Partnership Nhs Trust
Leicester, Leicestershire, United Kingdom, LE5 0TD
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, United Kingdom, LN2 4AX
Nottinghamshire Healthcare Nhs Trust
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Nottingham University Hospitals Nhs Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Richard K Morriss, MRC Psych University of Nottingham

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02298036     History of Changes
Other Study ID Numbers: CLAHRC-EM 14056
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Nottingham:
Health Anxiety
Urgent Care
Medically Unexplained