Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03424512
Other study ID # ULiverpool
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 10, 2018

Study information

Verified date August 2022
Source University of Liverpool
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date December 10, 2018
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Group Metacognitive Therapy
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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
University of Liverpool Liverpool University Hospitals NHS Foundation Trust, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cognitive Attentional Syndrome-1 (CAS-1) Measures severity of rumination and worry Change in CAS-1 at up to 10 weeks through study completion
Secondary Fear of Cancer Recurrence Inventory (FCRI) Measures severity of fear of cancer recurrence Change in FCRI at up to 10 weeks through study completion
Secondary Metacognition Questionnaire-30 (MCQ-30) Measures a range of metacognitive beliefs Change in MCQ-30 at up to 10 weeks through study completion
Secondary Impact of Events Scale-Revised (IES-R) Measures trauma related symptoms Change in IES-R at up to 10 weeks through study completion
Secondary Functional Assessment of Cancer Therapy- General (FACT-G) Measures cancer specific quality of life Change in FACT-G at up to 10 weeks through study completion
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A