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

Sponsor
University of Liverpool (Other)
Overall Status
Completed
CT.gov ID
NCT02580656
Collaborator
Medical Research Council (Other)
28
Enrollment
1
Location
1
Arm
18
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Metacognitive Therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hospital Anxiety and Depression Scale (HADS-Total) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Liverpool and Broadgreen NHS Trust Liverpool Merseyside United Kingdom L78XP

    Sponsors and Collaborators

    • University of Liverpool
    • Medical Research Council

    Investigators

    • Principal Investigator: Peter FISHER, PhD, University of Liverpool

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Fisher, Dr, University of Liverpool
    ClinicalTrials.gov Identifier:
    NCT02580656
    Other Study ID Numbers:
    • UoL001166
    First Posted:
    Oct 20, 2015
    Last Update Posted:
    Oct 3, 2017
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Anxiety Disorders

    Study Results

    No Results Posted as of Oct 3, 2017