NCT02404116

Brief Summary

The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT) which has shown promising results in the treatment of health anxiety to no treatment at all- a waiting list.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

March 23, 2015

Last Update Submit

February 6, 2017

Conditions

Hypochondriasis

Outcome Measures

Primary Outcomes (2)

  • Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7)

    Measures the presence of health anxiety.

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

  • Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP).

    Measures the presence of health anxiety.

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

Secondary Outcomes (5)

  • Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

  • Change in general metacognition levels over 12weeks of treatment measured by the The Metacognitions Questionaire-30 (MCQ-30)

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

  • Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

  • Change in health anxious metacognition levels over 12weeks of treatment measured by the The Meta-Cognitions about Health Questionnaire (MCHQ)

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

  • Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire

    This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion

Study Arms (2)

Metacognitive Therapy

EXPERIMENTAL

12 weeks of Metacognitive Therapy

Other: Metacognitive Therapy

Wait List Control

OTHER

The Waiting list control will control for time and repeated assessments during an initial 12 week period

Other: Wait List

Interventions

Metacognitive TherapyOTHER

Participants will receive treatment which focus's on helping reduce excessive thinking about health,

Metacognitive Therapy
Wait ListOTHER

Individuals are on a waiting list

Wait List Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be over 18.
  • Exceed cut off on BP and WI
  • Not undergoing any other form of psychological therapy during treatment.
  • If on medication must be stable six weeks prior to treatment onset.
  • Willing to undergo randomisation
  • Provide written consent

You may not qualify if:

  • Be under 18
  • Not exceeding cut off on BP and WI
  • Undergone CBT for health anxiety over the past three months.
  • Having started medication less than four weeks before assessment
  • Not willing to undergo randomisation
  • Not willing to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Central Lancashire

Preston, Lancashire, PR12HE, United Kingdom

Location

University of Manchester

Manchester, Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Hypochondriasis

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Robin Bailey, MSc

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

GB(2)