Fluid Restriction and Quality of Life on Dialysis

December 7, 2022 updated by: University of Oxford

Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients

Almost 30,000 people in the UK receive dialysis due to end stage renal disease (ESRD). Although dialysis prolongs life, people receiving dialysis are still typically bothered by a range of physical symptoms and need to make substantial adjustments in order to accommodate ESRD and its treatment. One adjustment that is often required is a dramatic reduction in fluid intake. Although sticking to fluid intake restrictions improves the efficiency of dialysis, monitoring fluid intake is complicated. The restrictions also leave people feeling very thirsty so restrictions can be hard to stick to. This project will develop and test a brief psychological intervention for people who struggle to adhere to fluid intake restrictions and will aim to increase quality of life whilst on dialysis. The intervention will be developed with input from people with lived experience of ESRD. It will then be offered to 12 people, recruited from clinics, who will complete questionnaires to monitor experiences and symptoms before, during and after the intervention. Participants' data will be analysed to find out whether the intervention has been helpful in reducing fluid intake and improving quality of life. If the findings are promising, this would suggest that the intervention could be tested in a larger clinical study in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Please note: this study adopts a between-subjects concurrent multiple baseline single case ABC experimental design. Participant change within and across phases A (baseline, variable with participants randomised to a 6, 8, or 10 week baseline), B (4 week intervention phase) and C (4 week follow-up) will be explored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently receiving haemodialysis for end-stage kidney disease
  • Aged 18+
  • Adequate fluency in written and spoken English to undertake the intervention and complete measures (assessed by research psychologist during discussion of study commitment)
  • Willing and able to participate in face-to-face and/or digital delivery of a psychological intervention (e.g. if digital delivery is requested or/or necessitated by Covid 19 restrictions patient has access to a computer, tablet or phone).
  • Identified by clinical staff as having difficulty with adherence to fluid intake recommendations.
  • Consents to participation, including recording of video sessions for fidelity/adherence rating and supervision.

Exclusion Criteria:

  • • Lack of capacity to consent

    • Poorly controlled diabetes resulting in recent hospital admissions for hypo/hyperglycaemic episode(s)
    • Intellectual disability that prevents self-management of fluid intake

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT Matrix
Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations.
Behavioral: ACT Matrix
Participants will receive a 4 session psychological intervention based on the ACT Matrix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: baseline phase week 2
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
baseline phase week 2
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: baseline phase week 4
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
baseline phase week 4
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: baseline phase week 6
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
baseline phase week 6
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: baseline phase week 8 (those randomised to 8 and 10 week baselines only)
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
baseline phase week 8 (those randomised to 8 and 10 week baselines only)
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: baseline phase week 10 (those randomised to 10 week baseline only)
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
baseline phase week 10 (those randomised to 10 week baseline only)
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: intervention phase week 2
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
intervention phase week 2
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: intervention phase week 4
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
intervention phase week 4
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Time Frame: 4 week (from end of intervention) follow-up
This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).
4 week (from end of intervention) follow-up
Interdialytic weight gain
Time Frame: Baseline phase week 1
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 1
Interdialytic weight gain
Time Frame: Baseline phase week 2
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 2
Interdialytic weight gain
Time Frame: Baseline phase week 3
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 3
Interdialytic weight gain
Time Frame: Baseline phase week 4
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 4
Interdialytic weight gain
Time Frame: Baseline phase week 5
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 5
Interdialytic weight gain
Time Frame: Baseline phase week 6
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 6
Interdialytic weight gain
Time Frame: Baseline phase week 7 (those randomised to 8 or 10 week follow-up)
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 7 (those randomised to 8 or 10 week follow-up)
Interdialytic weight gain
Time Frame: Baseline phase week 8 (those randomised to 8 or 10 week follow-up)
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 8 (those randomised to 8 or 10 week follow-up)
Interdialytic weight gain
Time Frame: Baseline phase week 9 (those randomised to 10 week baselines)
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 9 (those randomised to 10 week baselines)
Interdialytic weight gain
Time Frame: Baseline phase week 10 (those randomised to 10 week baseline)
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Baseline phase week 10 (those randomised to 10 week baseline)
Interdialytic weight gain
Time Frame: intervention week 1
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
intervention week 1
Interdialytic weight gain
Time Frame: intervention week 2
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
intervention week 2
Interdialytic weight gain
Time Frame: intervention week 3
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
intervention week 3
Interdialytic weight gain
Time Frame: intervention week 4
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
intervention week 4
Interdialytic weight gain
Time Frame: four week follow-up
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
four week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Valuing Questionnaire
Time Frame: baseline week 1
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 1
Valuing Questionnaire
Time Frame: baseline week 2
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 2
Valuing Questionnaire
Time Frame: baseline week 3
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 3
Valuing Questionnaire
Time Frame: baseline week 4
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 4
Valuing Questionnaire
Time Frame: baseline week 5
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 5
Valuing Questionnaire
Time Frame: baseline week 6
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 6
Valuing Questionnaire
Time Frame: baseline week 7 (those randomised to 8 and 10 week baselines only)
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 7 (those randomised to 8 and 10 week baselines only)
Valuing Questionnaire
Time Frame: baseline week 8 (those randomised to 8 and 10 week baselines only)
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 8 (those randomised to 8 and 10 week baselines only)
Valuing Questionnaire
Time Frame: baseline week 9 (those randomised to 10 week baselines only)
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 9 (those randomised to 10 week baselines only)
Valuing Questionnaire
Time Frame: baseline week 10 (those randomised to 10 week baselines only)
This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).
baseline week 10 (those randomised to 10 week baselines only)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ; Kim et al., 2010)
Time Frame: Study intake assessment
This self-report measure includes 46 questions assessing adherence to medication, diet, fluid intake restrictions and participation in dialysis sessions. It has excellent psychometric properties.
Study intake assessment
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Time Frame: Baseline week 1
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Baseline week 1
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Time Frame: intervention week 1
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
intervention week 1
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Time Frame: intervention week 4
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
intervention week 4
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Time Frame: Four week follow-up
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Four week follow-up
EQ-5D-5L (EuroQuol Group, 2009).
Time Frame: Baseline phase week 1
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Baseline phase week 1
EQ-5D-5L (EuroQuol Group, 2009).
Time Frame: Intervention week 1
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Intervention week 1
EQ-5D-5L (EuroQuol Group, 2009).
Time Frame: Intervention week 4
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Intervention week 4
EQ-5D-5L (EuroQuol Group, 2009).
Time Frame: Four week follow-up
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Four week follow-up
Dialysis Symptoms Index (Weisbord et al., 2004)
Time Frame: Baseline week 1
Measure of common physical and psychological symptoms experienced by people on dialysis
Baseline week 1
Dialysis Symptoms Index (Weisbord et al., 2004)
Time Frame: Intervention week 1
Measure of common physical and psychological symptoms experienced by people on dialysis
Intervention week 1
Dialysis Symptoms Index (Weisbord et al., 2004)
Time Frame: Intervention week 4
Measure of common physical and psychological symptoms experienced by people on dialysis
Intervention week 4
Dialysis Symptoms Index (Weisbord et al., 2004)
Time Frame: Four week follow-up
Measure of common physical and psychological symptoms experienced by people on dialysis
Four week follow-up
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Time Frame: Baseline week 1
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Baseline week 1
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Time Frame: Intervention week 1
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Intervention week 1
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Time Frame: Intervention week 4
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Intervention week 4
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Time Frame: Four week follow-up
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Four week follow-up
Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
Time Frame: Intervention week 1
measure of participants' views on intervention credibility
Intervention week 1
Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
Time Frame: Four week follow-up
measure of participants' views on intervention credibility
Four week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oxford University Hospitals NHS Trust
Oxford Health NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine H Crane, DPhil, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PID15290

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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