Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

NCT ID: NCT03424512

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-12-10

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.

Conditions

Cancer; Anxiety; Depression; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Group Metacognitive Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Peter Fisher

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Fisher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Royal Liverpool and Broadgreen NHS Trust

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ULiverpool

Identifier Type: -

Identifier Source: org_study_id