Authors
»
Patel, Shireen -More
Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2016
INTERVENTION: Following eligibility screening and baseline assessment the researcher will enter the service user participants details onto a web‐based randomisation system (set up by University of Nottingham Clinical trial Unit; CTU). Participants will be allocated with equal probability to each treatment arm with stratification by region. Service user participants will be randomly allocated to one of two treatment arms: remote CBT intervention (in addition to usual treatment) or treatment as usual only. Remotely delivered CBT intervention: A team of experienced CBT practitioners will deliver CBT for health anxiety remotely using a treatment manual developed from the CHAMP study (Tyrer, 2013). Six to twelve sessions will be offered. The intervention will address the symptoms of health anxiety from a cognitive‐behavioural perspective. This will include safety‐ seeking behaviours (e.g. reassurance seeking or phobic avoidance); cognitive biases (e.g. misinterpretations of physical sensations due to selectively attending to potential threats); physiological sensations (e.g. pain and discomfort from excessive checking), and affective symptoms (e.g. anxiety and depression). The CBT intervention will be delivered remotely via video calling or over the telephone depending on the participant’s preference. Upon completion of the remote treatment intervention participants from the remote intervention treatment arm of the study will be continue to access their usual care services. A summary of the finalised treatment action plan will then be distributed to the participant and their GP or other healthcare providers with the participant’s consent. Treatment as usual: Treatment as usual will be that decided by the service user with their general practitioner and other clinicians they consult for unscheduled care. Treatment as usual will be unconstrained other than it will not be provided by the treatment intervention therapists. Follow up questionnaires will be completed by participant CONDITION: Specialty: Mental Health, Primary sub‐specialty: Anxiety ; Mental and Behavioural Disorders ; Anxiety PRIMARY OUTCOME: Health anxiety is measured using the short form 14 item Health Anxiety Inventory (HAI) at baseline and 6 months. INCLUSION CRITERIA: 1. = 2 consultations, referrals or hospital admissions with any provider of unscheduled or emergency care (including urgent same day appointment at their general practice) in last 12 months for symptoms such as cardiac, respiratory, neurological, gastrointestinal or genitourinary problems not attributed to identified pathology 2. Scores above the threshold for severe health anxiety of 18 or more on the 14 item short form of the Health Anxiety Inventory (HAI) 3. Age 18 years and over 4. Sufficient understanding of English (spoken and written) to enable full engagement in the intervention 5. Able and willing to give oral and written informed consent to participate in the study SECONDARY OUTCOME: .1 Health anxiety is measured using the Short form 14 item Health Anxiety Inventory (HAI) at baseline 3, 6, 9 and 12 months ; 2. Generalised anxiety is measured using the 7 item Generalised Anxiety Disorder (GAD) at baseline 3, 6, 9 and 12 months; 3. Somatic distress is measured using the 15 item Patient Health Questionnaire (PHQ‐15) at baseline 3, 6, 9 and 12 months; 4. Depression is measured using the 9 item Patient Health Questionnaire for depression (PHQ‐9) at baseline 3, 6, 9 and 12 months; 5. Social function is measured using the 8 item Work and Social Adjustment Scale (WSAS) at baseline 3, 6, 9 and 12 months; 6. v5 item quality of life on the EQ5D‐5L (EuroQol) at baseline 3,6,9 and 12 months; 7. Physical and Mental health status is measured using the 36 item Short Form Health Survey (SF‐36) at baseline, 6 and 12 months; 8. Number of contacts with unscheduled or emergency care established through a totally adapted and stylised Client Service Receipt Inventory (CSRI) at baseline, 3, 6, 9 and 12 months
Epistemonikos ID: b69ea65b34aa756ddaecb35dc910da2d9593963e
First added on: Aug 24, 2024