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

An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580656
Enrollment
28
Registered
2015-10-20
Start date
2016-01-31
Completion date
2017-07-31
Last updated
2017-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Cancer

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.

Interventions

MCT helps patients to understand the deleterious and counterproductive effects of responding to negative thoughts and feelings with worry and rumination. Treatment aims to enable patients to exert greater metacognitive control over their worry and rumination. The positive and negative metacognitive beliefs that keep perseverative thinking in place are modified, using verbal and behavioural reattribution and through specifically designed therapeutic methods.

Sponsors

Medical Research Council
CollaboratorOTHER_GOV
University of Liverpool
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS-Total)Change in HADS total following the course of the six week intervention and over the six month follow-upA general measure of anxiety and depression used in people

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026