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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Depression, Cancer

Intervention / Treatment
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* Behavioral: Metacognitive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Therapy<br>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<br>* 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.<br>* Other names: MCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |