An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer

September 29, 2017 updated by: Peter Fisher, University of Liverpool

An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L78XP
        • Royal Liverpool and Broadgreen NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Metacognitive Therapy
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.
Behavioral: Metacognitive Therapy
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.
Other Names:
  • MCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS-Total)
Time Frame: Change in HADS total following the course of the six week intervention and over the six month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool

Collaborators

Medical Research Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

September 27, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL001166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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