Diabetes MellitusNCT03700528
The Development of Contextual Cognitive Behavioural Approach to PDN
A study testing Acceptance and Commitment Therapy (ACT) in people with Diabetes Mellitus and Painful Diabetic Neuropathy, run by King's College London at 2 sites in United Kingdom.
Trial summary
Diabetes mellitus (DM) is highly prevalent, and a significant public health problem. Approximately 25-30% of all individuals with DM develop painful diabetic neuropathy (PDN). PDN is considered a complex, multi-dimensional condition, possibly affecting the physical and mental health of the individual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Painful Diabetic Neuropathy
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged at least 18 years.
- Confirmed diagnosis of diabetes.
- Presence of painful diabetic neuropathy.
- Have full verbal and written proficiency in English.
- Willingness and ability to take part.
- Have computer literacy.
Who cannot join
- Not understanding verbal explanation or written information in English.
- Suffering from neuropathy due to other causes than diabetes.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
St Thomas' NHS Foundation Trust (Diabetes Clinic)
London, SE1 7EH
Stephen Thomas, +44 (0)20 7188 1981, stephen.m.thomas@gstt.nhs.uk
- Recruiting
Guy's hospital NHS Foundation Trust (Diabetes Clinic)
London, SE1 9RT
Stephen Thomas, +44 (0)20 7188 1981, stephen.m.thomas@gstt.nhs.uk
About this study
Official title: The Development of Contextual Cognitive Behavioural Approach to Painful Diabetic Neuropathy: A Feasibility Trial
Diabetes mellitus (DM) is highly prevalent, and a significant public health problem. Approximately 25-30% of all individuals with DM develop painful diabetic neuropathy (PDN). PDN is considered a complex, multi-dimensional condition, possibly affecting the physical and mental health of the individual. PDN is usually described as a sense of burning, stabbing, aching and/or pricking mainly affecting areas like toes, legs, and feet and physically interfering with mobility, sleep, mood, and overall quality of life. This condition represents both a significant problem in its own right and a useful condition in which to test treatments that may offer wider benefits for neuropathic pain conditions in general.
A relatively new and promising approach to chronic pain, within the wider range of cognitive and behavioural approaches, is Acceptance and Commitment Therapy (ACT). ACT is a form of Cognitive Behavioural Therapy (CBT) that focuses specifically on increasing psychological flexibility. Psychological flexibility is the capacity to change or continue with a behaviour, depending on which is more effective, according to one's goals and what the current situation affords. Psychological flexibility in turn includes processes of acceptance, values-based action, and other processes related to mindfulness. There are no published studies of ACT for individuals with PDN, and the limited available evidence indicates that a CBT-based intervention like ACT has the potential to reduce pain in people with PDN. People with PDN have clear treatment needs. While ACT may help them, little is known directly about the relevance of different components of ACT for this condition or about how to customise it for them. The proposed research aims to conduct a small feasibility trial which will pilot test a psychological treatment for PDN and assess the feasibility, acceptability and effectiveness of such a treatment.
Read the detailed description
People with diabetes often experience a type of pain called Painful Diabetic Neuropathy (PDN). PDN is described as a stabbing, burning, pricking, or aching sensation affecting the toes, feet, and legs. This type of pain can interfere with walking, sleep, mood and overall quality of life. Although medication may offer some short-term improvement in this pain, this is a chronic condition for the majority of the patients and the pain typically remains a problem. Our research team aims to assess the acceptability and potential benefits of a psychological treatment for people with PDN.
The intervention is a tailored ACT-based self-management intervention which will be delivered online. The purpose of this intervention is to improve participant daily functioning via increased psychological flexibility. The development of the PDN ACT-based intervention involved a multidisciplinary team of psychologists, health professionals and diabetes specialists.
The ACT treatment package will embrace the core treatment processes of acceptance, cognitive defusion, mindfulness, and values-based action. Methods will include practice in contacting painful experiences, experiential cognitive methods to promote awareness, exercises similar to mindfulness, methods to increase one's the role of goals and values in patient choice, and to help people flexibly stick to commitments.
The process will involve, two brief direct one-to-one contact sessions, one at the beginning and one at the end of the intervention, with convenient means according to each participant, as for example Skype, phone or face to face. Following the first one-to-one session there will be 8 short online sessions, with a duration of 20-30 minutes each. In accordance with ACT principles, participants will be encouraged to complete tasks between the online sessions. Particularly, they will be asked to write on a diary weekly, which will include ratings for openness, awareness and engagement. Within the diary we will also ask participants to note changes, in medication, if any, and if the data is sufficient and relevant we will include them in the final analysis. The completion of these tasks has been found to be predictive of CBT outcomes.
- Conditions
- Diabetes Mellitus, Painful Diabetic Neuropathy
- Being tested
- Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
The process will involve, two, brief, one-to-one contact sessions, one at the beginning and one at the end of the intervention, in a way that is convenient for participants, including Skype, phone, or face to face in person. Following the first one-to-one session there will be eight short online sessions, about 20-30 minutes each. Participants will also be asked to complete some tasks between the sessions, in particular to record their progress briefly and any changes at their medication (i.e. type of drug, dose) in a diary weekly so that they can keep track of your developing skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a single-cohort ACT based intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Committed Action Questionnaire (CAQ-8)
The CAQ-8 is an eight-item measure of committed action, a facet of PF. Committed action is the ability to persist with actions that are guided by goals, including when this runs into discouraging experiences and to change these actions when they are shown to be ineffective. Responses to the items were rated from 0 (never true) to 6 (always true). Out of the eight items four are positively keyed and four negatively keyed.
Measured: 8 weeks
Secondary outcomes (7)
Cognitive Fusion Questionnaire (CFQ-7)
The CFQ-7 offers a psychometrically sound measure of cognitive fusion. 16 Cognitive fusion refers to a domination of cognitive influence over direct experiential influence on behavior, and a lack of separation between the content of the thoughts and the situations or people to which they refer. Cognitive defusion, on the other hand, is the ability to see thoughts as just thoughts, and not as essential reflections of events as they are directly experienced. CFQ-7 consists of 7-items rated on a 0 (never true) to 7 (always true) point scale. An early version of the CFQ has been validated in chronic pain sample.
Measured: 8 weeks
Chronic Pain Acceptance Questionnaire (CPAQ-8)
The CPAQ-8 is a validated questionnaire which measures acceptance of chronic pain. It includes engagement in activities while experiencing pain and willingness to experience pain without trying to control or avoid it. CPAQ-8 is based on the 20-item questionnaire and has been validated 12. Items are rated on a scale from 0 (never true) to 6 (always true). Higher scores reflect greater acceptance of pain.
Measured: 8 weeks
Douleur neuropathique 4 (DN4)
Presence of neuropathic pain was assessed with a screening measure called DN4. It consists of interview questions and physical tests and has also been validated as a self-reported measure. It has a specificity of 83% and sensitivity of 90%.
Measured: 8 weeks
Pain Scale
Pain intensity and distress were assessed through four questions using 0 (no pain) to 10 (worst possible pain) numerical ratings of pain. Participants were asked to rate their pain right now and in the past week, and how distressing is their pain right now and in the past week.
Measured: 8 weeks
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a reliable and validated measure used as an index for depression severity. It includes 10-items based on DSM-IV. The nine items that reflect severity of depression symptoms area each rated on a scale from 0 (not at all) to 4 (nearly every day). The last item is a measure of impact of depression and is rated from 'not difficult at all' to 'extremely difficult'. The higher score indicates higher levels of depression severity.
Measured: 8 weeks
Self Experiences Questionnaire (SEQ)
The SEQ is a 15-item self-report measure of self-as-context (SAC), within the PF model. This "contextual self" is defined as a sense of self that is not based upon self-evaluations and is separate from one's thoughts and feelings. This could also be referred as, taking a point of view on one's psychological experiences, or as "perspective taking". All items are rated on a scale from 0 (never true) to 6 (always true). All items are positively keyed, and higher scores indicate higher PF.
Measured: 8 weeks
Work and Social Adjustment Scale (WSAS)
The WSAS is a five-item, reliable and validated, self-report measure of impairment in work and social functioning, or as we label in here, "functional impairment". Each item is rated from 0 (no impairment) to 8 (very severe impairment). WSAS items refer to work, home management, social and private leisure, and relationships.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The psychological treatment which we will use is called Acceptance and Commitment Therapy (ACT). The ACT treatment includes treatment processes of acceptance, cognitive defusion, mindfulness, and values-based action. Methods will include practice to deal with painful experiences, to improve awareness, to identify and work on goals, and to better stick to commitments.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700528
- Sponsor's protocol ID
- IRAS ID 224386
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: King's College London (KCL) and Guy's and St Thomas' NHS Foundation trust (GSTT) are the co-sponsors for this study based in the United Kingdom. They will be using information from participants in order to undertake this study and will act as the data controller for this study. This means that they are responsible for looking after participants' information and using it properly. King's College London and Guy's and St Thomas' NHS Foundation trust will keep identifiable information about participants for 7 years after the study has finished. Participants rights to access, change or move information are limited, as KCL and GSTT need to manage participants information in specific ways in order for the research to be reliable and accurate. If participants withdraw from the study, KCL and GSTT will keep the information about them that have already been obtained. To safeguard participants rights, KCL and GSTT will use the minimum personally-identifiable information possible.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Contextual Cognitive Behavioural Approach to Painful Diabetic Neuropathy: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03700528
- Acronym / sponsor ID
- IRAS ID 224386
- Conditions
- Diabetes Mellitus, Painful Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes mellitus (DM) is highly prevalent, and a significant public health problem. Approximately 25-30% of all individuals with DM develop painful diabetic neuropathy (PDN). PDN is considered a complex, multi-dimensional condition, possibly affecting the physical and mental health of the individual. PDN is usually described as a sense of burning, stabbing, aching and/or pricking mainly affecting areas like toes, legs, and feet and physically interfering with mobility, sleep, mood, and overall quality of life. This condition represents both a significant problem in its own right and a useful condition in which to test treatments that may offer wider benefits for neuropathic pain conditions in general.
A relatively new and promising approach to chronic pain, within the wider range of cognitive and behavioural approaches, is Acceptance and Commitment Therapy (ACT). ACT is a form of Cognitive Behavioural Therapy (CBT) that focuses specifically on increasing psychological flexibility. Psychological flexibility is the capacity to change or continue with a behaviour, depending on which is more effective, according to one's goals and what the current situation affords. Psychological flexibility in turn includes processes of acceptance, values-based action, and other processes related to mindfulness. There are no published studies of ACT for individuals with PDN, and the limited available evidence indicates that a CBT-based intervention like ACT has the potential to reduce pain in people with PDN. People with PDN have clear treatment needs. While ACT may help them, little is known directly about the relevance of different components of ACT for this condition or about how to customise it for them. The proposed research aims to conduct a small feasibility trial which will pilot test a psychological treatment for PDN and assess the feasibility, acceptability and effectiveness of such a treatment.
Detailed description
People with diabetes often experience a type of pain called Painful Diabetic Neuropathy (PDN). PDN is described as a stabbing, burning, pricking, or aching sensation affecting the toes, feet, and legs. This type of pain can interfere with walking, sleep, mood and overall quality of life. Although medication may offer some short-term improvement in this pain, this is a chronic condition for the majority of the patients and the pain typically remains a problem. Our research team aims to assess the acceptability and potential benefits of a psychological treatment for people with PDN.
The intervention is a tailored ACT-based self-management intervention which will be delivered online. The purpose of this intervention is to improve participant daily functioning via increased psychological flexibility. The development of the PDN ACT-based intervention involved a multidisciplinary team of psychologists, health professionals and diabetes specialists.
The ACT treatment package will embrace the core treatment processes of acceptance, cognitive defusion, mindfulness, and values-based action. Methods will include practice in contacting painful experiences, experiential cognitive methods to promote awareness, exercises similar to mindfulness, methods to increase one's the role of goals and values in patient choice, and to help people flexibly stick to commitments.
The process will involve, two brief direct one-to-one contact sessions, one at the beginning and one at the end of the intervention, with convenient means according to each participant, as for example Skype, phone or face to face. Following the first one-to-one session there will be 8 short online sessions, with a duration of 20-30 minutes each. In accordance with ACT principles, participants will be encouraged to complete tasks between the online sessions. Particularly, they will be asked to write on a diary weekly, which will include ratings for openness, awareness and engagement. Within the diary we will also ask participants to note changes, in medication, if any, and if the data is sufficient and relevant we will include them in the final analysis. The completion of these tasks has been found to be predictive of CBT outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The psychological treatment which we will use is called Acceptance and Commitment Therapy (ACT). The ACT treatment includes treatment processes of acceptance, cognitive defusion, mindfulness, and values-based action. Methods will include practice to deal with painful experiences, to improve awareness, to identify and work on goals, and to better stick to commitments.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)This is a single-cohort ACT based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged at least 18 years.
- Confirmed diagnosis of diabetes.
- Presence of painful diabetic neuropathy.
- Have full verbal and written proficiency in English.
- Willingness and ability to take part.
Key exclusion criteria (2 listed)
- Not understanding verbal explanation or written information in English.
- Suffering from neuropathy due to other causes than diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)The process will involve, two, brief, one-to-one contact sessions, one at the beginning and one at the end of the intervention, in a way that is convenient for participants, including Skype, phone, or face to face in person. Following the first one-to-one session there will be eight short online sessions, about 20-30 minutes each. Participants will also be asked to complete some tasks between the sessions, in particular to record their progress briefly and any changes at their medication (i.e. type of drug, dose) in a diary weekly so that they can keep track of your developing skills. | Behavioural | Intervention |
Primary outcome
Committed Action Questionnaire (CAQ-8)
Time frame: 8 weeks
The CAQ-8 is an eight-item measure of committed action, a facet of PF. Committed action is the ability to persist with actions that are guided by goals, including when this runs into discouraging experiences and to change these actions when they are shown to be ineffective. Responses to the items were rated from 0 (never true) to 6 (always true). Out of the eight items four are positively keyed and four negatively keyed.
7 secondary outcomes
Cognitive Fusion Questionnaire (CFQ-7)
Time frame: 8 weeks
Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time frame: 8 weeks
Douleur neuropathique 4 (DN4)
Time frame: 8 weeks
Pain Scale
Time frame: 8 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 8 weeks
Self Experiences Questionnaire (SEQ)
Time frame: 8 weeks
Work and Social Adjustment Scale (WSAS)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No. King's College London (KCL) and Guy's and St Thomas' NHS Foundation trust (GSTT) are the co-sponsors for this study based in the United Kingdom. They will be using information from participants in order to undertake this study and will act as the data controller for this study. This means that they are responsible for looking after participants' information and using it properly. King's College London and Guy's and St Thomas' NHS Foundation trust will keep identifiable information about participants for 7 years after the study has finished. Participants rights to access, change or move information are limited, as KCL and GSTT need to manage participants information in specific ways in order for the research to be reliable and accurate. If participants withdraw from the study, KCL and GSTT will keep the information about them that have already been obtained. To safeguard participants rights, KCL and GSTT will use the minimum personally-identifiable information possible.
Related trials for Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
St Thomas' NHS Foundation Trust (Diabetes Clinic)
London, United Kingdom
Guy's hospital NHS Foundation Trust (Diabetes Clinic)
London, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Diabetes Mellitus and Painful Diabetic Neuropathy, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Committed Action Questionnaire (CAQ-8) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.