NCT02991183

Brief Summary

Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice and accept difficult thoughts and emotions. ACT also helps people to identify what they value in life (e.g. a good relationship with their partner) and make changes to their behaviour to promote these values. Carers of people with dementia may experience reduced wellbeing associated with their role. Those whose wellbeing is greater than previously are said to be 'flourishing'. Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group intervention for carers of people with dementia. Methods: Participants will include adult carers of people with dementia. Study participants will be identified from two older people community mental health teams. Informed consent will be sought prior to group invitations being sent out. There will be two groups in total (12 in each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will complete questionnaires at the beginning and 21 days later (asking questions about their thoughts and feelings, flourishing and about being a carer). Eight group participants will be invited to a focus group to understand what they found more helpful and less helpful. Applications: Results from this study will potentially provide useful information to enable a further study with more participants to be conducted. The outcomes of this study will be shared with older people community mental health teams, dementia and carer specialist groups and potentially published in a relevant journal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

August 22, 2017

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

December 2, 2016

Last Update Submit

August 17, 2017

Conditions

Keywords

CaregiversAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (4)

  • Number of participants recruited and retained to study completion

    4 weeks

  • Well-being

    Change in score from Mental Health Continuum Short Form questionnaire

    Time 0 and week 4

  • Acceptability

    Qualitative responses to Acceptability questionnaire devised by research team

    4 weeks

  • Fidelity

    Fidelity of the intervention to the ACT approach (measure developed by research team)

    4 weeks

Secondary Outcomes (3)

  • Psychological Flexibility

    Time 0 and week 4

  • Psychological Flexibility in Caregivers

    Time 0 and week 4

  • Caregiver Burden

    Time 0 and week 4

Study Arms (1)

Acceptance and Commitment Therapy

EXPERIMENTAL

Two half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session.

Behavioral: ACT

Interventions

ACTBEHAVIORAL

A psychological therapy to help people i) notice and accept difficult thoughts and emotions; ii) identify what they value in life and iii) make changes to their behaviour to promote these values.

Acceptance and Commitment Therapy

Eligibility Criteria

Age18 Years - 116 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • carers of people with a diagnosis of any type of dementia
  • primary caregiver of the person with dementia for 3 months or more
  • informed consent
  • adequate English language skills

You may not qualify if:

  • receiving any type of concurrent psychotherapy
  • diagnosis of a severe or acute mental health problem (such as psychosis, anxiety, depression) when consent to participate is sought

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hamish McLeod, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 13, 2016

Study Start

February 17, 2017

Primary Completion

April 21, 2017

Study Completion

August 17, 2017

Last Updated

August 22, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations