An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Jan 2016
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 3, 2017
September 1, 2017
1.5 years
September 27, 2015
September 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale (HADS-Total)
A general measure of anxiety and depression used in people
Change in HADS total following the course of the six week intervention and over the six month follow-up
Study Arms (1)
Metacognitive Therapy
EXPERIMENTALMetacognitive 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Cancer diagnosis at least 6 months previously
- Scoring \>15 on the Hospital Anxiety and Depression Scale Total
- Stable on, or free from, psychotropic medication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Liverpoollead
- Medical Research Councilcollaborator
Study Sites (1)
Royal Liverpool and Broadgreen NHS Trust
Liverpool, Merseyside, L78XP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter FISHER, PhD
University of Liverpool
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 27, 2015
First Posted
October 20, 2015
Study Start
January 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
October 3, 2017
Record last verified: 2017-09