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NCT Number: NCT02580656

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Liverpool and Broadgreen NHS Trust

Liverpool, Merseyside, L78XP, United Kingdom

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metacognitive Therapy

Behavioral

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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