<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02991183</url>
  </required_header>
  <id_info>
    <org_study_id>GN16MH672</org_study_id>
    <nct_id>NCT02991183</nct_id>
  </id_info>
  <brief_title>ACT for Carers of People With Dementia</brief_title>
  <official_title>A Feasibility Study of Acceptance and Commitment Therapy (ACT) to Promote the Wellbeing of Carers of People With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice&#xD;
      and accept difficult thoughts and emotions. ACT also helps people to identify what they value&#xD;
      in life (e.g. a good relationship with their partner) and make changes to their behaviour to&#xD;
      promote these values. Carers of people with dementia may experience reduced wellbeing&#xD;
      associated with their role. Those whose wellbeing is greater than previously are said to be&#xD;
      'flourishing'.&#xD;
&#xD;
      Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group&#xD;
      intervention for carers of people with dementia.&#xD;
&#xD;
      Methods: Participants will include adult carers of people with dementia. Study participants&#xD;
      will be identified from two older people community mental health teams. Informed consent will&#xD;
      be sought prior to group invitations being sent out. There will be two groups in total (12 in&#xD;
      each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will&#xD;
      complete questionnaires at the beginning and 21 days later (asking questions about their&#xD;
      thoughts and feelings, flourishing and about being a carer). Eight group participants will be&#xD;
      invited to a focus group to understand what they found more helpful and less helpful.&#xD;
&#xD;
      Applications: Results from this study will potentially provide useful information to enable a&#xD;
      further study with more participants to be conducted. The outcomes of this study will be&#xD;
      shared with older people community mental health teams, dementia and carer specialist groups&#xD;
      and potentially published in a relevant journal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: two groups of participants will receive the ACT group intervention (Total n=24;&#xD;
      n/Group = 12). One group of participants (n=8) who attend the ACT intervention will be&#xD;
      invited to a focus group exploring intervention acceptability.&#xD;
&#xD;
      Recruitment Procedures: prior to recruitment commencing the researcher will present details&#xD;
      of the study (recruitment procedures, eligibility criteria etc.) to the relevant Community&#xD;
      Mental Health Teams (CMHTs) and at the Older Adult Psychology Team meeting. Carers of People&#xD;
      with Dementia (CPwD) will be identified by National Health Service (NHS) staff working in&#xD;
      Older People's CMHTs.&#xD;
&#xD;
      Potential participants will receive patient information sheet at routine appointments they&#xD;
      attend with the person with dementia for whom they care. Carers will provide permission for&#xD;
      their contact details to be passed to the research team using 'Notice of Interest' slip. The&#xD;
      researcher will then arrange to meet with the carer to recruit them to the study. Informed&#xD;
      consent will be sought and a member of the research team will complete a consent form with&#xD;
      participants after they have had time to read the Participant Information Sheet. Consenting&#xD;
      participants will be sent appointment letters with further details of the group.&#xD;
&#xD;
      Measures: participants will complete the following measures at the beginning and end of the&#xD;
      ACT group intervention:&#xD;
&#xD;
        1. Demographic questionnaire (including age, gender, length of time being in a caring role,&#xD;
           fulltime or part-time carers, any other employment, number of individuals they care for,&#xD;
           and their relationship to the individual they care for (e.g. spouse, sibling, child,&#xD;
           other).&#xD;
&#xD;
        2. Acceptance and Action Questionnaire: (AAQII). The AAQII is a 7 item questionnaire, which&#xD;
           measures psychological flexibility on a 7 point Likert scale.&#xD;
&#xD;
        3. Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a 14 item questionnaire,&#xD;
           measuring wellbeing on a 6 point Likert scale.&#xD;
&#xD;
        4. Experiential Avoidance in Caregiving Questionnaire (EACQ) The EACQ is a 15 item&#xD;
           questionnaire, which measures experiential avoidance on a 5 point Likert scale.&#xD;
&#xD;
        5. Caregiver Burden Scale (CBS).The CBS is a 21 item questionnaire, which measures the&#xD;
           overall level of burden carers experience in relation to their spouse or relative on a 5&#xD;
           point Likert scale.&#xD;
&#xD;
        6. Recruitment and retention parameters: A sample size of at least 12 people per group for&#xD;
           pilot pharmaceutical studies will be an indicator of sufficient recruitment. However, 8&#xD;
           has been suggested as the optimum number of group participants in psychological&#xD;
           interventions. Therefore, a figure of no more than 33% attrition from baseline to final&#xD;
           assessment will be used to indicate that the ACT group intervention is feasible in terms&#xD;
           of retention.&#xD;
&#xD;
        7. Group Evaluation Form: A brief survey will be completed with Likert scales and free text&#xD;
           boxes for reflections on participants experience of attending the ACT groups.&#xD;
&#xD;
        8. Focus group: A smaller number of participants (n = 8) will also be invited to attend a&#xD;
           focus group to explore their view of taking part in the ACT groups. This will be&#xD;
           audio-recorded and transcribed for analysis.&#xD;
&#xD;
      Design: this project will be an uncontrolled feasibility trial, using convenience sampling,&#xD;
      and measuring a range of variables pertinent to the feasibility of delivering ACT&#xD;
      intervention groups for CPwD. Process evaluation methodology, including quantitative and&#xD;
      qualitative methods, will be applied to measure feasibility of the group intervention and&#xD;
      develop a greater understanding of the intervention delivered and its causal assumptions (see&#xD;
      research questions above).&#xD;
&#xD;
      Quantitative data collected will include demographic information, number of participants&#xD;
      recruited and retained throughout the study, outcome measures (carer burden, psychological&#xD;
      flexibility, flourishing), and responses to Likert scale acceptability questions. Qualitative&#xD;
      data will include responses to open-ended acceptability questions in the format of a&#xD;
      questionnaire and focus group exploring participants' experience of attending the groups.&#xD;
&#xD;
      Research Procedures Measures will be completed by all participants at baseline (beginning of&#xD;
      group) and 21 days post-baseline (end of group). Baseline measures will be completed prior to&#xD;
      the first session. Post-baseline measures will be completed following the third session.&#xD;
      Feedback surveys will be given to all participants at the last group session with Likert&#xD;
      scales and free text boxes for reflections on their experience of attending the ACT groups.&#xD;
&#xD;
      A focus group of 8 participants who have completed the ACT group intervention will be&#xD;
      conducted by a facilitator independent from the ACT group facilitators. The participants will&#xD;
      be selected to provide a range of experiences of the group to elicit rich discussion and&#xD;
      qualitative data regarding acceptability. A semi-structured interview will be used to guide&#xD;
      discussions (including open questions related to group format and structure, ACT approach,&#xD;
      practicalities of attending) but the participants will be encouraged to openly discuss their&#xD;
      opinions of their experience of the ACT group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Actual">August 17, 2017</completion_date>
  <primary_completion_date type="Actual">April 21, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants recruited and retained to study completion</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Well-being</measure>
    <time_frame>Time 0 and week 4</time_frame>
    <description>Change in score from Mental Health Continuum Short Form questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>4 weeks</time_frame>
    <description>Qualitative responses to Acceptability questionnaire devised by research team</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fidelity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fidelity of the intervention to the ACT approach (measure developed by research team)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological Flexibility</measure>
    <time_frame>Time 0 and week 4</time_frame>
    <description>Change in score from Acceptance and Action Questionnaire-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Flexibility in Caregivers</measure>
    <time_frame>Time 0 and week 4</time_frame>
    <description>Change in score from Experiential Avoidance in Caregiving Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden</measure>
    <time_frame>Time 0 and week 4</time_frame>
    <description>Change in score from Caregiver Burden Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACT</intervention_name>
    <description>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.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  carers of people with a diagnosis of any type of dementia&#xD;
&#xD;
          -  primary caregiver of the person with dementia for 3 months or more&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  adequate English language skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  receiving any type of concurrent psychotherapy&#xD;
&#xD;
          -  diagnosis of a severe or acute mental health problem (such as psychosis, anxiety,&#xD;
             depression) when consent to participate is sought&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>116 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hamish McLeod, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregivers</keyword>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991183
org study id: GN16MH672
nct id: NCT02991183
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Participants: two groups of participants will receive the ACT group intervention (Total n=24;
      n/Group = 12). One group of participants (n=8) who attend the ACT intervention will be
      invited to a focus group exploring intervention acceptability.

      Recruitment Procedures: prior to recruitment commencing the researcher will present details
      of the study (recruitment procedures, eligibility criteria etc.) to the relevant Community
      Mental Health Teams (CMHTs) and at the Older Adult Psychology Team meeting. Carers of People
      with Dementia (CPwD) will be identified by National Health Service (NHS) staff working in
      Older People's CMHTs.

      Potential participants will receive patient information sheet at routine appointments they
      attend with the person with dementia for whom they care. Carers will provide permission for
      their contact details to be passed to the research team using 'Notice of Interest' slip. The
      researcher will then arrange to meet with the carer to recruit them to the study. Informed
      consent will be sought and a member of the research team will complete a consent form with
      participants after they have had time to read the Participant Information Sheet. Consenting
      participants will be sent appointment letters with further details of the group.

      Measures: participants will complete the following measures at the beginning and end of the
      ACT group intervention:

        1. Demographic questionnaire (including age, gender, length of time being in a caring role,
           fulltime or part-time carers, any other employment, number of individuals they care for,
           and their relationship to the individual they care for (e.g. spouse, sibling, child,
           other).

        2. Acceptance and Action Questionnaire: (AAQII). The AAQII is a 7 item questionnaire, which
           measures psychological flexibility on a 7 point Likert scale.

        3. Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a 14 item questionnaire,
           measuring wellbeing on a 6 point Likert scale.

        4. Experiential Avoidance in Caregiving Questionnaire (EACQ) The EACQ is a 15 item
           questionnaire, which measures experiential avoidance on a 5 point Likert scale.

        5. Caregiver Burden Scale (CBS).The CBS is a 21 item questionnaire, which measures the
           overall level of burden carers experience in relation to their spouse or relative on a 5
           point Likert scale.

        6. Recruitment and retention parameters: A sample size of at least 12 people per group for
           pilot pharmaceutical studies will be an indicator of sufficient recruitment. However, 8
           has been suggested as the optimum number of group participants in psychological
           interventions. Therefore, a figure of no more than 33% attrition from baseline to final
           assessment will be used to indicate that the ACT group intervention is feasible in terms
           of retention.

        7. Group Evaluation Form: A brief survey will be completed with Likert scales and free text
           boxes for reflections on participants experience of attending the ACT groups.

        8. Focus group: A smaller number of participants (n = 8) will also be invited to attend a
           focus group to explore their view of taking part in the ACT groups. This will be
           audio-recorded and transcribed for analysis.

      Design: this project will be an uncontrolled feasibility trial, using convenience sampling,
      and measuring a range of variables pertinent to the feasibility of delivering ACT
      intervention groups for CPwD. Process evaluation methodology, including quantitative and
      qualitative methods, will be applied to measure feasibility of the group intervention and
      develop a greater understanding of the intervention delivered and its causal assumptions (see
      research questions above).

      Quantitative data collected will include demographic information, number of participants
      recruited and retained throughout the study, outcome measures (carer burden, psychological
      flexibility, flourishing), and responses to Likert scale acceptability questions. Qualitative
      data will include responses to open-ended acceptability questions in the format of a
      questionnaire and focus group exploring participants' experience of attending the groups.

      Research Procedures Measures will be completed by all participants at baseline (beginning of
      group) and 21 days post-baseline (end of group). Baseline measures will be completed prior to
      the first session. Post-baseline measures will be completed following the third session.
      Feedback surveys will be given to all participants at the last group session with Likert
      scales and free text boxes for reflections on their experience of attending the ACT groups.

      A focus group of 8 participants who have completed the ACT group intervention will be
      conducted by a facilitator independent from the ACT group facilitators. The participants will
      be selected to provide a range of experiences of the group to elicit rich discussion and
      qualitative data regarding acceptability. A semi-structured interview will be used to guide
      discussions (including open questions related to group format and structure, ACT approach,
      practicalities of attending) but the participants will be encouraged to openly discuss their
      opinions of their experience of the ACT group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants recruited and retained to study completion
time frame: 4 weeks
measure: Well-being
time frame: Time 0 and week 4
description: Change in score from Mental Health Continuum Short Form questionnaire
measure: Acceptability
time frame: 4 weeks
description: Qualitative responses to Acceptability questionnaire devised by research team
measure: Fidelity
time frame: 4 weeks
description: Fidelity of the intervention to the ACT approach (measure developed by research team)
measure: Psychological Flexibility
time frame: Time 0 and week 4
description: Change in score from Acceptance and Action Questionnaire-II
measure: Psychological Flexibility in Caregivers
time frame: Time 0 and week 4
description: Change in score from Experiential Avoidance in Caregiving Questionnaire
measure: Caregiver Burden
time frame: Time 0 and week 4
description: Change in score from Caregiver Burden Scale
arm group label: Acceptance and Commitment Therapy
arm group type: Experimental
description: Two half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session.
intervention type: Behavioral
intervention name: ACT
description: 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.
arm group label: Acceptance and Commitment Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 116 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hamish McLeod, PhD
role: Principal Investigator
affiliation: University of Glasgow
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No