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A Feasibility Study of a Transdiagnostic Compassion Focused Therapy (CFT) Group for Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039542
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

Compassion focused therapy (CFT) is a relatively new psychological therapy. Research has shown that CFT can improve psychological wellbeing and functioning in people with anxiety and depressive disorders. Research into CFT has focused on working age adults. It would be useful to evaluate whether CFT could be of benefit to the older adult population.

The present study aims to use the Medical Research Council (MRC) framework for developing and evaluating new treatments for complex conditions such as mental health. The present study aims to explore the feasibility and acceptability of a CFT group as a treatment for older adults with anxiety or depressive disorders. Additionally, the study aims to use the statistical data to inform future research.

Participants will be older adults (aged 60+) referred to National Health Service (NHS) Greater Glasgow and Clyde (GGC) older people's mental health service for common mental health conditions. People with psychosis, addictions, diagnosis of dementia or risk of self-harm will be ineligible. Participants will be offered the group as part of their treatment. Participants in the group will be identified and approached by an NHS clinician and asked to consent to participate in the study; non participation in the study will not affect their place in the group. The group protocol has been developed from previous research and will last for 10 weekly sessions of 90 minutes.

The study is mixed methods, using both quantitative and qualitative data. The quantitative part will use outcome measures which will look for a statistical relationship between the CFT group and changes in wellbeing and functioning. The qualitative part will use a semi-structured interview to hear people's experiences.

The CFT group will be delivered by an NHS clinical psychologist and Community Psychiatric Nurse (CPN).


Condition or disease Intervention/treatment Phase
Depression Anxiety Disorders Other: Compassion focused therapy (CFT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Mixed methods - qualitative and quantitative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mixed Methods Feasibility Study of a Transdiagnostic Compassion Focused Therapy (CFT) Group for Older Adults
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Compassion focused therapy (CFT)
A group programme of CFT running for 10 sessions lasting 90 minutes per session.
Other: Compassion focused therapy (CFT)
Compassion focused therapy (CFT) sessions (developed from cognitive behavioural therapies) to target underlying shame and self-criticism - 10 x 90 minute sessions




Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Baseline, 5 weeks and 10 weeks ]
    Change in Patient Health Questionnaire (PHQ-9) score: 9 item self-report measure. Scale range 0-27; higher score indicates increase in depression symptoms (worse)

  2. Anxiety symptoms [ Time Frame: Baseline, 5 weeks and 10 weeks ]
    Change in Generalized Anxiety Disorder (GAD-7) score: 7 item self-report measure. Scale range 0-21; higher score indicates increase in anxiety symptoms (worse)


Secondary Outcome Measures :
  1. Self-criticism/self-reassurance [ Time Frame: Baseline, 9 weeks and 10 weeks ]
    Change in Forms of self-criticising/attacking & self-reassuring scale (FSCRS) score: inadequate self sub-scale. Scale range 0-36; higher score indicates an increase in feelings of personal inadequacy (worse)

  2. Self-criticism/self-reassurance [ Time Frame: Baseline, 9 weeks and 10 weeks ]
    Change in Forms of self-criticising/attacking & self-reassuring scale (FSCRS) score: hated self sub-scale. Scale range 0-20; higher score indicates an increase in feelings of desire to persecute oneself (worse)

  3. Self-criticism/self-reassurance [ Time Frame: Baseline, 9 weeks and 10 weeks ]
    Change in Forms of self-criticising/attacking & self-reassuring scale (FSCRS) score: reassured self sub-scale. Scale range 0-32; higher score indicates an increase in feelings of ability to reassure oneself (better)

  4. Self-compassion [ Time Frame: Baseline, 8 weeks and 10 weeks ]
    Change in Self-compassion scale (SCS) total score. Scale range 0-130; higher score indicates an increase in feelings of self-compassion (better)

  5. Mindfulness traits [ Time Frame: Baseline, 7 weeks and 10 weeks ]
    Change in Toronto Mindfulness Scale - Trait score. Scale range 0-52; higher score indicates an increase in experiences of mindfulness (better)

  6. Belief of others' evaluation [ Time Frame: Baseline 5 weeks and 10 weeks ]
    Change in Other as Shamer Scale score. Scale range 0-72; higher score indicates an increase in feelings of external shame (worse)

  7. Social connectedness [ Time Frame: Baseline, 5 weeks and 10 weeks ]
    Change in Social Connectedness Scale - Revised score. Scale range 8-48; higher score indicates more social connectedness (better)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experiencing symptoms of depression and/or anxiety disorder
  • Able to provide informed consent
  • English fluency

Exclusion Criteria:

  • Psychosis
  • Addictions
  • Cognitive impairment
  • Risk of self-harm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039542


Contacts
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Contact: Fiona McConnell +44 141 211 3922 f.mcconnell.1@research.gla.ac.uk
Contact: Hamish McLeod, PhD +44 141 211 3922 hamish.mcleod@glasgow.ac.uk

Locations
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United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Study Chair: Hamish McLeod, PhD University of Glasgow
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04039542    
Other Study ID Numbers: GN19MH088
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
Feasibility
Compassion Focussed Therapy
Older adults
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders