Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

Depression Clinical Trial

— GMAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03424512
• Other study ID #: ULiverpool
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: August 2022
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Liverpool and Broadgreen NHS Trust	Liverpool	Merseyside

Sponsors (3)

Lead Sponsor	Collaborator
University of Liverpool	Liverpool University Hospitals NHS Foundation Trust, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

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