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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580656
• Other study ID #: UoL001166
• Status: Completed
• Phase: N/A
• First received: September 27, 2015
• Last updated: September 29, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Metacognitive Therapy
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Liverpool	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS-Total)	A general measure of anxiety and depression used in people	Change in HADS total following the course of the six week intervention and over the six month follow-up