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

NCT ID: NCT02580656

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

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.

Conditions

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Anxiety Depression Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Metacognitive Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MCT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Peter Fisher

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter FISHER, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

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Royal Liverpool and Broadgreen NHS Trust

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UoL001166

Identifier Type: -

Identifier Source: org_study_id