Clinical trial NCT03424512: Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
Official title: An Open Trial of Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Anxiety
Depression
Quality of Life
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2018-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital Anxiety Depression Scale-Total (HADS-Total)
timeFrame: Change in HADS total at up to 10 weeks through study completion
Secondary outcomes:
measure: Cognitive Attentional Syndrome-1 (CAS-1)
timeFrame: Change in CAS-1 at up to 10 weeks through study completion
measure: Fear of Cancer Recurrence Inventory (FCRI)
timeFrame: Change in FCRI at up to 10 weeks through study completion
measure: Metacognition Questionnaire-30 (MCQ-30)
timeFrame: Change in MCQ-30 at up to 10 weeks through study completion
measure: Impact of Events Scale-Revised (IES-R)
timeFrame: Change in IES-R at up to 10 weeks through study completion
measure: Functional Assessment of Cancer Therapy- General (FACT-G)
timeFrame: Change in FACT-G at up to 10 weeks through study completion
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen NHS Trust
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Peter Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References: