Clinical trial NCT02580656: An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer
Official title: An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Cancer
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2015-10-20
Enrollment: 28
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: 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. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.

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. There is scope for improvements in the efficacy of current pharmacological and psychological interventions. 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.

This study addresses the stages of 'development' and 'piloting and feasibility' in intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of 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 MCT in cancer survivors.

Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis at least 6 months previously
* Scoring \>15 on the Hospital Anxiety and Depression Scale Total
* Stable on, or free from, psychotropic medication

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 treatment
* Cognitive impairment precluding informed consent or participation

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS-Total)
timeFrame: Change in HADS total following the course of the six week intervention and over the six month follow-up
Secondary outcomes:
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: