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ACT for Carers of People With Dementia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991183
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: ACT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Acceptance and Commitment Therapy (ACT) to Promote the Wellbeing of Carers of People With Dementia
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Acceptance and Commitment Therapy
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
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.




Primary Outcome Measures :
  1. Number of participants recruited and retained to study completion [ Time Frame: 4 weeks ]
  2. Well-being [ Time Frame: Time 0 and week 4 ]
    Change in score from Mental Health Continuum Short Form questionnaire

  3. Acceptability [ Time Frame: 4 weeks ]
    Qualitative responses to Acceptability questionnaire devised by research team

  4. Fidelity [ Time Frame: 4 weeks ]
    Fidelity of the intervention to the ACT approach (measure developed by research team)


Secondary Outcome Measures :
  1. Psychological Flexibility [ Time Frame: Time 0 and week 4 ]
    Change in score from Acceptance and Action Questionnaire-II

  2. Psychological Flexibility in Caregivers [ Time Frame: Time 0 and week 4 ]
    Change in score from Experiential Avoidance in Caregiving Questionnaire

  3. Caregiver Burden [ Time Frame: Time 0 and week 4 ]
    Change in score from Caregiver Burden Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 116 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02991183


Locations
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United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Hamish McLeod, PhD University of Glasgow
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02991183    
Other Study ID Numbers: GN16MH672
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Caregivers
Acceptance and Commitment Therapy
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders