DepressionNCT04039542
A Feasibility Study of a Transdiagnostic Compassion Focused Therapy (CFT) Group for Older Adults
A study testing Compassion focused therapy (CFT) in people with Depression and Anxiety Disorders, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Compassion focused therapy (CFT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2019to 30 Nov 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing symptoms of depression and/or anxiety disorder
- Able to provide informed consent
- English fluency
Who cannot join
- Psychosis
- Addictions
- Cognitive impairment
- Risk of self-harm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed Methods Feasibility Study of a Transdiagnostic Compassion Focused Therapy (CFT) Group for Older Adults
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.
Read more
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).
Read the detailed description
Recruitment Procedure:
Potential participants will be recruited from the older adult service within NHS GGC. Multidisciplinary team (MDT) staff within the service will identify potential participants for a CFT group and if they agree to participate in the group, attendees will then be asked to participate in the study by the student researcher. Group attendees' inclusion in the group is not dependent on their participation in the study. Inclusion and exclusion criteria will be assessed by Principal Clinical Psychologist and eligible participants will be asked for their consent to participate in the project by Trainee Clinical Psychologist.
Outcome Measures:
Principal Clinical Psychologist will administer outcome measures at beginning and end of the group programme. Additionally, measures will be administered after specific sessions to assess the effect of specific interventions.
Outcome measures to be used are -
Clinical Outcomes:
- Patient Health Questionnaire (PHQ-9) - a 9 item self-report measure of depressive symptoms.1 minute completion time. Administered after sessions 1, 5, 10.
- Generalized Anxiety Disorder (GAD-7) - a 7 item self-report measure of anxiety symptoms. 1 minute completion time Administered after sessions 1, 5, 10.
Mechanisms of Change:
- Forms of self-criticising/attacking \& self-reassuring scale (FSCRS) - a self-report measure of self-criticism and self-reassurance. Used to evaluate the level of self-criticism a person experiences, which is often linked to mental health problems. Additionally, it evaluates the ability to reassure oneself. 4 minutes completion time.
Administered after sessions 1, 9, 10.
- Self-compassion scale (SCS) - a self-report measure measures a person's ability to show themselves compassion in the face of challenges. 4 minutes completion time. Administered after sessions 1, 8, 10.
- Toronto Mindfulness Scale - Trait - a self report measure of mindfulness traits such as curiosity, acceptance and openness. Given the CFT group incorporates elements of mindfulness, this will be useful to measure. 3 minutes completion time. Administered after sessions 1, 7, 10.
- Other as Shamer Scale - a self-repost measure to evaluate beliefs a person has about other's evaluation of them. 3 minutes completion time. Administered after sessions 1, 5, 10.
- Social Connectedness Scale - Revised - a self-report measure which evaluate people's feelings of connectedness to others. To measure whether the group itself has an impact on people's feelings. 4 minutes completion time. Administered after sessions 1, 5, 10.
Design:
As this is a feasibility study, a mix methods study design will be used. For the quantitative part of the study a within group design will be used to assess outcomes at baseline and posttreatment. Treatment acceptability will also be evaluated by semi-structured interviews following the intervention.
CFT Protocol:
A group programme of CFT will run for 10 sessions lasting 90 minutes per session. The group has been developed by an experienced NHS Clinical Psychologist working with older adults. The group protocol has been developed from a previous group run in NHS GGC with working age adults. The group will be delivered by NHS clinicians and led by Dr John Hickey. The sessions are titled as follows:
Session 1: Introduction, aims and soothing rhythm breathing Session 2 \& 3: Psychoeducation Session 4: Formulation Session 5: Formulation \& the threat system Session 6: Compassionate Self Session 7: Compassionate Image and barriers to compassion Session 8: Multiple selves - responding with different emotions Session 9: Shame and self-criticism Session 10: Review, formulation and planning ahead Participants will be asked to practice techniques and record their progress throughout the intervention. They will practice breathing and mindfulness techniques and keep a compassionate diary to support their learning.
Data Collection:
All outcome measures will be completed by participants pre-intervention, they will be posted to participants prior to the group (once consent has been received) and they will be asked to bring them to the first session. Copies will be available at the first session in case participants forget to bring them or have difficulties completing them. Time will be available to complete measures if necessary. The measures will also be repeated after specific sessions to evaluate any change from a specific intervention. Demographic data will also be obtained to allow for a description of the data.
The lead clinician will administer and collect the outcome measures at the end of the specified session. Attendance and dropout from the group will also be recorded for analysis.
Following the completion of the group, participants will be asked to attend for a semi-structured interview to discuss their experience of the CFT group protocol. All those who consented to participate in the study will be asked to participate in the semi-structured interview. The interviews will be conducted by Fiona McConnell (Trainee Clinical Psychologist). Interviews will be based on a topic guide, which will focus on the participant's experience of the intervention and their thoughts for improvements. The interviews will be audio recorded and transcribed and all patient identifiable data will be anonymised. The recordings will be destroyed once the project is complete.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Compassion focused therapy (CFT)
- Keywords
- Feasibility, Compassion Focussed Therapy, Older adults
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion focused therapy (CFT)Other
Compassion focused therapy (CFT) sessions (developed from cognitive behavioural therapies) to target underlying shame and self-criticism - 10 x 90 minute sessions
| Study group | Role | What they receive |
|---|---|---|
| Compassion focused therapy (CFT) | Experimental | A group programme of CFT running for 10 sessions lasting 90 minutes per session. Receives: Other: Compassion focused therapy (CFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
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)
Measured: Baseline, 5 weeks and 10 weeks
Anxiety symptoms
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)
Measured: Baseline, 5 weeks and 10 weeks
Secondary outcomes (7)
Self-criticism/self-reassurance
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)
Measured: Baseline, 9 weeks and 10 weeks
Self-criticism/self-reassurance
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)
Measured: Baseline, 9 weeks and 10 weeks
Self-criticism/self-reassurance
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)
Measured: Baseline, 9 weeks and 10 weeks
Self-compassion
Change in Self-compassion scale (SCS) total score. Scale range 0-130; higher score indicates an increase in feelings of self-compassion (better)
Measured: Baseline, 8 weeks and 10 weeks
Mindfulness traits
Change in Toronto Mindfulness Scale - Trait score. Scale range 0-52; higher score indicates an increase in experiences of mindfulness (better)
Measured: Baseline, 7 weeks and 10 weeks
Belief of others' evaluation
Change in Other as Shamer Scale score. Scale range 0-72; higher score indicates an increase in feelings of external shame (worse)
Measured: Baseline 5 weeks and 10 weeks
Social connectedness
Change in Social Connectedness Scale - Revised score. Scale range 8-48; higher score indicates more social connectedness (better)
Measured: Baseline, 5 weeks and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start19 Jun 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2021
Why it stopped: COVID-19 restrictions limited recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Model description
- Mixed methods - qualitative and quantitative
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Hamish McLeod, PhD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039542
- Sponsor's protocol ID
- GN19MH088
- Status last verified
- Dec 2021
- First submitted
- 1 Jul 2019
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Feasibility Study of a Transdiagnostic Compassion Focused Therapy (CFT) Group for Older Adults
- ClinicalTrials.gov ID
- NCT04039542
- Acronym / sponsor ID
- GN19MH088
- Conditions
- Depression, Anxiety Disorders
- Keywords
- Feasibility, Compassion Focussed Therapy, Older adults
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 restrictions limited recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 Jul 2019 (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.
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).
Detailed description
Recruitment Procedure:
Potential participants will be recruited from the older adult service within NHS GGC. Multidisciplinary team (MDT) staff within the service will identify potential participants for a CFT group and if they agree to participate in the group, attendees will then be asked to participate in the study by the student researcher. Group attendees' inclusion in the group is not dependent on their participation in the study. Inclusion and exclusion criteria will be assessed by Principal Clinical Psychologist and eligible participants will be asked for their consent to participate in the project by Trainee Clinical Psychologist.
Outcome Measures:
Principal Clinical Psychologist will administer outcome measures at beginning and end of the group programme. Additionally, measures will be administered after specific sessions to assess the effect of specific interventions.
Outcome measures to be used are -
Clinical Outcomes:
- Patient Health Questionnaire (PHQ-9) - a 9 item self-report measure of depressive symptoms.1 minute completion time. Administered after sessions 1, 5, 10.
- Generalized Anxiety Disorder (GAD-7) - a 7 item self-report measure of anxiety symptoms. 1 minute completion time Administered after sessions 1, 5, 10.
Mechanisms of Change:
- Forms of self-criticising/attacking \& self-reassuring scale (FSCRS) - a self-report measure of self-criticism and self-reassurance. Used to evaluate the level of self-criticism a person experiences, which is often linked to mental health problems. Additionally, it evaluates the ability to reassure oneself. 4 minutes completion time.
Administered after sessions 1, 9, 10.
- Self-compassion scale (SCS) - a self-report measure measures a person's ability to show themselves compassion in the face of challenges. 4 minutes completion time. Administered after sessions 1, 8, 10.
- Toronto Mindfulness Scale - Trait - a self report measure of mindfulness traits such as curiosity, acceptance and openness. Given the CFT group incorporates elements of mindfulness, this will be useful to measure. 3 minutes completion time. Administered after sessions 1, 7, 10.
- Other as Shamer Scale - a self-repost measure to evaluate beliefs a person has about other's evaluation of them. 3 minutes completion time. Administered after sessions 1, 5, 10.
- Social Connectedness Scale - Revised - a self-report measure which evaluate people's feelings of connectedness to others. To measure whether the group itself has an impact on people's feelings. 4 minutes completion time. Administered after sessions 1, 5, 10.
Design:
As this is a feasibility study, a mix methods study design will be used. For the quantitative part of the study a within group design will be used to assess outcomes at baseline and posttreatment. Treatment acceptability will also be evaluated by semi-structured interviews following the intervention.
CFT Protocol:
A group programme of CFT will run for 10 sessions lasting 90 minutes per session. The group has been developed by an experienced NHS Clinical Psychologist working with older adults. The group protocol has been developed from a previous group run in NHS GGC with working age adults. The group will be delivered by NHS clinicians and led by Dr John Hickey. The sessions are titled as follows:
Session 1: Introduction, aims and soothing rhythm breathing Session 2 \& 3: Psychoeducation Session 4: Formulation Session 5: Formulation \& the threat system Session 6: Compassionate Self Session 7: Compassionate Image and barriers to compassion Session 8: Multiple selves - responding with different emotions Session 9: Shame and self-criticism Session 10: Review, formulation and planning ahead Participants will be asked to practice techniques and record their progress throughout the intervention. They will practice breathing and mindfulness techniques and keep a compassionate diary to support their learning.
Data Collection:
All outcome measures will be completed by participants pre-intervention, they will be posted to participants prior to the group (once consent has been received) and they will be asked to bring them to the first session. Copies will be available at the first session in case participants forget to bring them or have difficulties completing them. Time will be available to complete measures if necessary. The measures will also be repeated after specific sessions to evaluate any change from a specific intervention. Demographic data will also be obtained to allow for a description of the data.
The lead clinician will administer and collect the outcome measures at the end of the specified session. Attendance and dropout from the group will also be recorded for analysis.
Following the completion of the group, participants will be asked to attend for a semi-structured interview to discuss their experience of the CFT group protocol. All those who consented to participate in the study will be asked to participate in the semi-structured interview. The interviews will be conducted by Fiona McConnell (Trainee Clinical Psychologist). Interviews will be based on a topic guide, which will focus on the participant's experience of the intervention and their thoughts for improvements. The interviews will be audio recorded and transcribed and all patient identifiable data will be anonymised. The recordings will be destroyed once the project is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods - qualitative and quantitative
| Arm | Type | Receives |
|---|---|---|
| Compassion focused therapy (CFT) | Experimental | Other: Compassion focused therapy (CFT)A group programme of CFT running for 10 sessions lasting 90 minutes per session. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experiencing symptoms of depression and/or anxiety disorder
- Able to provide informed consent
- English fluency
Key exclusion criteria (4 listed)
- Psychosis
- Addictions
- Cognitive impairment
- Risk of self-harm
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 |
|---|---|---|
| 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 | Other | Compassion focused therapy (CFT) |
Primary outcome
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)
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)
7 secondary outcomes
Self-criticism/self-reassurance
Time frame: Baseline, 9 weeks and 10 weeks
Self-criticism/self-reassurance
Time frame: Baseline, 9 weeks and 10 weeks
Self-criticism/self-reassurance
Time frame: Baseline, 9 weeks and 10 weeks
Self-compassion
Time frame: Baseline, 8 weeks and 10 weeks
Mindfulness traits
Time frame: Baseline, 7 weeks and 10 weeks
Belief of others' evaluation
Time frame: Baseline 5 weeks and 10 weeks
Social connectedness
Time frame: Baseline, 5 weeks and 10 weeks
Results and safety
The study was stopped early (reason given: COVID-19 restrictions limited recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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.
Hamish McLeod, PhD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion focused therapy (CFT) in people with Depression and Anxiety Disorders, run by NHS Greater Glasgow and Clyde 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 3 inclusion and 4 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 Dec 2021. 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 restrictions limited recruitment). 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?
Depressive symptoms (time frame: Baseline, 5 weeks and 10 weeks). The study lists 2 primary outcomes in all. 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 Dec 2021.