An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer
Primary Purpose
Anxiety, Depression, Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metacognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Cancer diagnosis at least 6 months previously
- Scoring >15 on the Hospital Anxiety and Depression Scale Total
- Stable on, or free from, psychotropic medication
Exclusion Criteria:
- History of psychotic disorder, learning disability, or organic mental disorder
- Risk of self-harm or suicide warranting immediate intervention
- In palliative phase of treatment
- Being considered for risk-reducing or reconstructive surgery within 1 year
- Concurrent psychological treatment
- Cognitive impairment precluding informed consent or participation
Sites / Locations
- Royal Liverpool and Broadgreen NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metacognitive Therapy
Arm Description
Metacognitive Therapy (MCT) is a brief psychological intervention which will be delivered over a course of six, one hour weekly sessions. Treatment will follow a manualised protocol.
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale (HADS-Total)
A general measure of anxiety and depression used in people
Secondary Outcome Measures
Full Information
NCT ID
NCT02580656
First Posted
September 27, 2015
Last Updated
September 29, 2017
Sponsor
University of Liverpool
Collaborators
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02580656
Brief Title
An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer
Official Title
An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liverpool
Collaborators
Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.
Detailed Description
Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. There is scope for improvements in the efficacy of current pharmacological and psychological interventions. Reflecting this limited efficacy in the face of the need for psychological treatment, the National Cancer Survivorship Research Initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. It is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. However modifications have been pragmatic rather than theory-driven and have not improved efficacy.
This study addresses the stages of 'development' and 'piloting and feasibility' in intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of MCT in other settings and promising preliminary evidence of applicability in cancer. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Description
Metacognitive Therapy (MCT) is a brief psychological intervention which will be delivered over a course of six, one hour weekly sessions. Treatment will follow a manualised protocol.
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Therapy
Other Intervention Name(s)
MCT
Intervention Description
MCT helps patients to understand the deleterious and counterproductive effects of responding to negative thoughts and feelings with worry and rumination. Treatment aims to enable patients to exert greater metacognitive control over their worry and rumination. The positive and negative metacognitive beliefs that keep perseverative thinking in place are modified, using verbal and behavioural reattribution and through specifically designed therapeutic methods.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS-Total)
Description
A general measure of anxiety and depression used in people
Time Frame
Change in HADS total following the course of the six week intervention and over the six month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer diagnosis at least 6 months previously
Scoring >15 on the Hospital Anxiety and Depression Scale Total
Stable on, or free from, psychotropic medication
Exclusion Criteria:
History of psychotic disorder, learning disability, or organic mental disorder
Risk of self-harm or suicide warranting immediate intervention
In palliative phase of treatment
Being considered for risk-reducing or reconstructive surgery within 1 year
Concurrent psychological treatment
Cognitive impairment precluding informed consent or participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter FISHER, PhD
Organizational Affiliation
University of Liverpool
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Liverpool and Broadgreen NHS Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L78XP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer
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