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

Primary Purpose

Cancer, Anxiety, Depression

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Group Metacognitive Therapy
Sponsored by
University of Liverpool
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Liverpool and Broadgreen NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Metacognitive Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Hospital Anxiety Depression Scale-Total (HADS-Total)
Measures severity of emotional distress

Secondary Outcome Measures

Cognitive Attentional Syndrome-1 (CAS-1)
Measures severity of rumination and worry
Fear of Cancer Recurrence Inventory (FCRI)
Measures severity of fear of cancer recurrence
Metacognition Questionnaire-30 (MCQ-30)
Measures a range of metacognitive beliefs
Impact of Events Scale-Revised (IES-R)
Measures trauma related symptoms
Functional Assessment of Cancer Therapy- General (FACT-G)
Measures cancer specific quality of life

Full Information

First Posted
October 3, 2017
Last Updated
August 25, 2022
Sponsor
University of Liverpool
Collaborators
University of Manchester, Liverpool University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03424512
Brief Title
Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
Acronym
GMAC
Official Title
An Open Trial of Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 halted study, reorganisation of the clincial service and staff leaving posts made recruitement to a group unfeasible
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liverpool
Collaborators
University of Manchester, Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Anxiety, Depression, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Metacognitive Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Group Metacognitive Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety Depression Scale-Total (HADS-Total)
Description
Measures severity of emotional distress
Time Frame
Change in HADS total at up to 10 weeks through study completion
Secondary Outcome Measure Information:
Title
Cognitive Attentional Syndrome-1 (CAS-1)
Description
Measures severity of rumination and worry
Time Frame
Change in CAS-1 at up to 10 weeks through study completion
Title
Fear of Cancer Recurrence Inventory (FCRI)
Description
Measures severity of fear of cancer recurrence
Time Frame
Change in FCRI at up to 10 weeks through study completion
Title
Metacognition Questionnaire-30 (MCQ-30)
Description
Measures a range of metacognitive beliefs
Time Frame
Change in MCQ-30 at up to 10 weeks through study completion
Title
Impact of Events Scale-Revised (IES-R)
Description
Measures trauma related symptoms
Time Frame
Change in IES-R at up to 10 weeks through study completion
Title
Functional Assessment of Cancer Therapy- General (FACT-G)
Description
Measures cancer specific quality of life
Time Frame
Change in FACT-G at up to 10 weeks through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Fisher, PhD
Organizational Affiliation
University of Liverpool
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Liverpool and Broadgreen NHS Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L78XP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

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