CancerGMACNCT03424512
Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
A study testing Group Metacognitive Therapy in people with Cancer and Anxiety, run by University of Liverpool at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Anxiety, Depression
- What is being tested?
- Group Metacognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool and Broadgreen NHS Trust
Liverpool, Merseyside, L78XP
About this study
Official title: An Open Trial of Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
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.
Read the 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. 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.
- Conditions
- Cancer, Anxiety, Depression, Quality of Life
- Being tested
- Group Metacognitive Therapy
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Metacognitive TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Group Metacognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety Depression Scale-Total (HADS-Total)
Measures severity of emotional distress
Measured: Change in HADS total at up to 10 weeks through study completion
Secondary outcomes (5)
Cognitive Attentional Syndrome-1 (CAS-1)
Measures severity of rumination and worry
Measured: Change in CAS-1 at up to 10 weeks through study completion
Fear of Cancer Recurrence Inventory (FCRI)
Measures severity of fear of cancer recurrence
Measured: Change in FCRI at up to 10 weeks through study completion
Metacognition Questionnaire-30 (MCQ-30)
Measures a range of metacognitive beliefs
Measured: Change in MCQ-30 at up to 10 weeks through study completion
Impact of Events Scale-Revised (IES-R)
Measures trauma related symptoms
Measured: Change in IES-R at up to 10 weeks through study completion
Functional Assessment of Cancer Therapy- General (FACT-G)
Measures cancer specific quality of life
Measured: Change in FACT-G at up to 10 weeks through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Apr 2018
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Why it stopped: Covid-19 halted study, reorganisation of the clincial service and staff leaving posts made recruitement to a group unfeasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Peter Fisher, University of Liverpool
- Investigators
- Peter Fisher, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424512
- Sponsor's protocol ID
- ULiverpool
- Acronym
- GMAC
- Status last verified
- Aug 2022
- First submitted
- 3 Oct 2017
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial of Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03424512
- Acronym / sponsor ID
- GMAC / ULiverpool
- Conditions
- Cancer, Anxiety, Depression, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 halted study, reorganisation of the clincial service and staff leaving posts made recruitement to a group unfeasible
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- University of Manchester, Liverpool University Hospitals NHS Foundation Trust
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Metacognitive Therapy | Experimental | Behavioral: Group Metacognitive TherapyGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Metacognitive TherapyGroup 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. | Behavioural | Group Metacognitive Therapy |
Primary outcome
Hospital Anxiety Depression Scale-Total (HADS-Total)
Time frame: Change in HADS total at up to 10 weeks through study completion
Measures severity of emotional distress
5 secondary outcomes
Cognitive Attentional Syndrome-1 (CAS-1)
Time frame: Change in CAS-1 at up to 10 weeks through study completion
Fear of Cancer Recurrence Inventory (FCRI)
Time frame: Change in FCRI at up to 10 weeks through study completion
Metacognition Questionnaire-30 (MCQ-30)
Time frame: Change in MCQ-30 at up to 10 weeks through study completion
Impact of Events Scale-Revised (IES-R)
Time frame: Change in IES-R at up to 10 weeks through study completion
Functional Assessment of Cancer Therapy- General (FACT-G)
Time frame: Change in FACT-G at up to 10 weeks through study completion
Results and safety
The study was stopped early (reason given: Covid-19 halted study, reorganisation of the clincial service and staff leaving posts made recruitement to a group unfeasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Fisher, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Metacognitive Therapy in people with Cancer and Anxiety, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 halted study, reorganisation of the clincial service and staff leaving posts made recruitement to a group unfeasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety Depression Scale-Total (HADS-Total) (time frame: Change in HADS total at up to 10 weeks through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.