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

University of Liverpool

Status: Terminated

Conditions: Quality of Life; Depression; Cancer; Anxiety

Treatments: Behavioral: Group Metacognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03424512

ULiverpool

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Group Metacognitive Therapy

Experimental group

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

Treatment:

Behavioral: Group Metacognitive Therapy