An interventional study of Group Metacognitive Therapy in Cancer, Anxiety and Depression, sponsored by University of Liverpool. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by University of Liverpool · Not applicable, Interventional, and Treatment
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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.
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.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 7,704 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Hospital Anxiety Depression Scale-Total (HADS-Total)
Measures severity of emotional distress
Time frame: Change in HADS total at up to 10 weeks through study completion
Cognitive Attentional Syndrome-1 (CAS-1)
Measures severity of rumination and worry
Time frame: Change in CAS-1 at up to 10 weeks through study completion
Fear of Cancer Recurrence Inventory (FCRI)
Measures severity of fear of cancer recurrence
Time frame: Change in FCRI at up to 10 weeks through study completion
Metacognition Questionnaire-30 (MCQ-30)
Measures a range of metacognitive beliefs
Time frame: Change in MCQ-30 at up to 10 weeks through study completion
Impact of Events Scale-Revised (IES-R)
Measures trauma related symptoms
Time frame: Change in IES-R at up to 10 weeks through study completion
Functional Assessment of Cancer Therapy- General (FACT-G)
Measures cancer specific quality of life
Time frame: Change in FACT-G at up to 10 weeks through study completion
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2018, 8 months.
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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of Liverpool