Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

NCT03424512 | Terminated

• 1 other identifier: ULiverpool
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Anxiety; Depression; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cognitive Attentional Syndrome-1 (CAS-1)

  Change in CAS-1 at up to 10 weeks through study completion

• Fear of Cancer Recurrence Inventory (FCRI)

  Change in FCRI at up to 10 weeks through study completion

• Metacognition Questionnaire-30 (MCQ-30)

  Change in MCQ-30 at up to 10 weeks through study completion

• Impact of Events Scale-Revised (IES-R)

  Change in IES-R at up to 10 weeks through study completion

• Functional Assessment of Cancer Therapy- General (FACT-G)

  Change in FACT-G at up to 10 weeks through study completion

Study Arms (1)

Group Metacognitive Therapy

EXPERIMENTAL

Group metacognitive therapy (MCT) is a brief psychological intervention designed to be delivered in small groups of 4-8 patients over a course of six, 90 minute sessions conducted on a weekly basis

Behavioral: Group Metacognitive Therapy

Interventions

Group Metacognitive Therapy BEHAVIORAL

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.

Group Metacognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead
• University of Manchester: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Royal Liverpool and Broadgreen NHS Trust

Liverpool, Merseyside, L78XP, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Peter Fisher, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: February 7, 2018
• Study Start: April 1, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)