NCT04039542

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

July 1, 2019

Last Update Submit

December 8, 2021

Conditions

DepressionAnxiety Disorders

Keywords

FeasibilityCompassion Focussed TherapyOlder adults

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    Baseline, 5 weeks and 10 weeks

Secondary Outcomes (7)

  • Self-criticism/self-reassurance

    Baseline, 9 weeks and 10 weeks

  • Self-criticism/self-reassurance

    Baseline, 9 weeks and 10 weeks

  • Self-criticism/self-reassurance

    Baseline, 9 weeks and 10 weeks

  • Self-compassion

    Baseline, 8 weeks and 10 weeks

  • Mindfulness traits

    Baseline, 7 weeks and 10 weeks

  • +2 more secondary outcomes

Study Arms (1)

Compassion focused therapy (CFT)

EXPERIMENTAL

A group programme of CFT running for 10 sessions lasting 90 minutes per session.

Other: Compassion focused therapy (CFT)

Interventions

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

Compassion focused therapy (CFT)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Hamish McLeod, PhD

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mixed methods - qualitative and quantitative
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 31, 2019

Study Start

June 19, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

GB(1)