Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors (GMAC)

August 25, 2022 updated by: Peter Fisher, University of Liverpool

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

This study aims to test the potential of group metacognitive therapy in alleviating emotional distress in cancer survivors. The investigators aim to find out if a group based approach is acceptable to patients and feasible to deliver in a routine clinical health psychology service.

Study Overview

Status

Terminated

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. Current pharmacological treatments are not very effective and are not well tolerated by patients, who prefer psychological treatments. However, meta-analyses of well-controlled studies of psychological treatments indicate that these achieve only small effect sizes. 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.

The study addresses the stages of 'development' and 'piloting and feasibility' in Medical Research Council guidance on intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of metacognitive therapy (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 group MCT in cancer survivors and the hypothesised causal metacognitive mechanisms underpinning treatment response.

Study Type

Interventional

Enrollment (Actual)

15

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
  • A score of at least 15 on the Total scale score of the Hospital Anxiety and Depression Scale (HADS)
  • Sufficient understanding of English to consent and engage in therapy
  • Stable on, or free from, psychotropic medication
  • Minimum of 18 years old

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 intervention for emotional distress
  • Cognitive impairment precluding informed consent or participation
  • Undergoing acute medical treatment (e.g. chemotherapy, radiotherapy)
  • Current drug/alcohol abuse

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Metacognitive Therapy
Group metacognitive therapy (MCT) is a brief psychological intervention designed to be delivered in small groups of 4-8 patients over a course of six, 90 minute sessions conducted on a weekly basis
Behavioral: Group Metacognitive Therapy
Group MCT is based on a manualised protocol and is structured in the following way. In session 1, idiosyncratic case formulations based on the generic metacognitive model are developed for each participant. Socialization helps patients to understand that worry/rumination and unhelpful coping strategies are maintaining emotional distress. Patients are then introduced to, and practice well established treatment techniques to modify negative beliefs about uncontrollability of rumination/worry. Later sessions address relapse prevention and involves modifying remaining use of the 'cognitive attentional syndrome', reviewing residual conviction in positive and negative beliefs and consolidating and strengthening alternative ways of responding to negative thoughts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety Depression Scale-Total (HADS-Total)
Time Frame: Change in HADS total at up to 10 weeks through study completion
Measures severity of emotional distress
Change in HADS total at up to 10 weeks through study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Attentional Syndrome-1 (CAS-1)
Time Frame: Change in CAS-1 at up to 10 weeks through study completion
Measures severity of rumination and worry
Change in CAS-1 at up to 10 weeks through study completion
Fear of Cancer Recurrence Inventory (FCRI)
Time Frame: Change in FCRI at up to 10 weeks through study completion
Measures severity of fear of cancer recurrence
Change in FCRI at up to 10 weeks through study completion
Metacognition Questionnaire-30 (MCQ-30)
Time Frame: Change in MCQ-30 at up to 10 weeks through study completion
Measures a range of metacognitive beliefs
Change in MCQ-30 at up to 10 weeks through study completion
Impact of Events Scale-Revised (IES-R)
Time Frame: Change in IES-R at up to 10 weeks through study completion
Measures trauma related symptoms
Change in IES-R at up to 10 weeks through study completion
Functional Assessment of Cancer Therapy- General (FACT-G)
Time Frame: Change in FACT-G at up to 10 weeks through study completion
Measures cancer specific quality of life
Change in FACT-G at up to 10 weeks through study completion

Collaborators and Investigators

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

Sponsor

University of Liverpool

Collaborators

Liverpool University Hospitals NHS Foundation Trust
University of Manchester

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 (Actual)

April 1, 2018

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULiverpool

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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