Brain Injuries, TraumaticEarly Phase 1REACTNCT02337114
Recovery Enhancement From Traumatic Brain Injury Using Acceptance and Commitment Therapy - a Pilot Study.
A Early Phase 1 study testing Acceptance and Commitment Therapy and Treatment as Usual in people with Brain Injuries, Traumatic, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Acceptance and Commitment Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Sep 2015
- Phase
- Early Phase 1
- 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
- All clients must:
- have sustained a severe TBI after the age of 18; indicated by presence of posttraumatic amnesia for a day or more OR loss of consciousness for 30 minutes or more following injury OR scores of eight or less on the Glasgow Coma Scale.
- have sufficient English language skills to enable valid participation using standard tests and questionnaires
- be admitted to BIRT for neuropsychological rehabilitation
- have sufficient cognitive capacity to complete questionnaires independently and participate in discussions as part of the ACT intervention.
- All psychology staff must have:
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- completed 1.5 day ACT training
- time and resources to:
- administer ACT intervention to at least one group of 3-4 clients once a week for a six week period within the time frame suggested for this pilot study
- participate in a focus group following intervention providing their views of the study protocol
- complete the SAFE questionnaire identifying barriers to treatment implementation
- Care staff not involved in delivering the intervention (including nursing staff and rehabilitation support workers)
- will have the time and resources to complete 2 questionnaires
- work directly with the clients receiving the intervention
- have commenced at BIRT employment prior to the first intervention session.
- will have the time and resources to participate in the focus group, if based at Graham Anderson House
Who cannot join
- Clients will be excluded from the study if they:
- lack capacity to consent to participate in research as assessed by staff at BIRT or by the researcher when discussing consent with the participant
- will remain in the unit for less than eight weeks
- have challenging behaviour that may put the researcher or participant at risk or prevent participation in the study.
- Psychology staff will be excluded if:
- they have not received the appropriate training
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- they consider that do not have the time and resources to partake in all the research tasks.
- Care staff will be excluded from this study if:
- they have commenced employment after the study procedures have commenced
- they believe they do not have the time and resources to complete research tasks
- they do not work directly with clients participating in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REACT - Recovery Enhancement From TBI Using ACT. A Pilot Study.
Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Psychological intervention may facilitate this change; however what works is unclear. ACT seeks to improve psychological flexibility; the ability to be present with difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what we believe we should be. Current research is limited, but what is published suggests it may be useful for this group.
Due to the limited research this pilot study aims to conduct preliminary analysis on the acceptability and feasibility of ACT for people with sTBI whilst also examining the suitability of the study protocol in order to make recommendations for future studies. Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be recruited, one of which will serve as the intervention centre.
Read more
Clients in the intervention group will be asked to complete questionnaires a week before and after participation in the 6 week ACT programme. Clients in the comparison group will be asked to complete questionnaires a week before and after receiving 6 weeks of treatment as usual (TAU). The treatment group will also receive TAU. All participants will be invited to participate in a focus group at the end of this 8 week period to discuss their involvement in the study.
Staff will be asked to complete a parallel version of one of the client questionnaires within a similar timeframe. In addition staff at the intervention centre will be invited to attend a focus group and complete an additional questionnaire after the eight week period.
Read the detailed description
A pilot study design will initially assess the feasibility and acceptability of the ACT and study protocol with this client group in order to inform a future clinical trial.
The methodology involves both quantitative and qualitative methods and will involve inpatients at Brain Injury Rehabilitation Trust (BIRT) units, staff involved in the day to day care of inpatients and clinicians involved in the administration of therapy. Quantitative methods (questionnaires) were chosen to assess any possible change in assessment measures. The measures chosen have been previously used. They have good validity (the ability to answer the questions asked) and reliability, and therefore are practically suitable for measuring outcomes of therapy. Qualitative methods (focus groups) were also chosen, owing to the pilot nature of this research, in order to obtain personal opinion on the acceptability of the intervention and the treatment protocol, from those participating.
The intervention will be administered, alongside TAU, to inpatients at a BIRT centre in Glasgow and will be compared to a comparison group which will receive TAU only (who will be based in BIRT centres in either York and/or Leeds). The rational for choosing a BIRT centre in Glasgow for the intervention group is one of convenience as all researchers involved in the study are based in Glasgow. This will help facilitate data collection and reduce cost. Given that all BIRT centres adhere to a similar philosophy of care and rehabilitation and service user profiles are relatively similar, it was believed that recruiting elsewhere for the purpose of comparison would be appropriate. Recruiting treatment and comparison groups from separate centres also ensures that clients receiving TAU only do not learn ACT strategies accidentally through discussion with peers or staff. If this were to happen any indication of change could not be attributed to the difference in treatments provided.
Five participant groups will be recruited:
- clients in the inpatient setting (treatment group),
- clients in the inpatient setting (comparison group),
- care staff working directly with clients (treatment group),
- care staff working directly with clients (comparison group)
- psychology staff involved in administering the intervention.
All participants will be provided with an information sheet and consent will be sought prior to their participation in the study. All interventions, assessments and focus groups will be completed at the participants respective centres. All recruitment, with the exception of the psychology staff who are a convenient sample, will be conducted by a staff member not involved in the direct write up of the study. Further to this all outcome measures and focus groups will be conducted by researchers not involved in the provision of treatment.
Psychology staff at the intervention centre who have completed training on ACT will be further informed of the study. If they choose to participate they will recruit clients at BIRT in Glasgow, completing a record form identifying inclusion and exclusion criteria met. This form will allow the staff to outline any barriers or difficulties encountered as part of this process. Information sheets will then be provided to recruited clients, in addition to care staff who work with them.
The study will also be explained to heads of service at each of the comparison sites, providing them both with an integrated protocol. They will identify a point of contact who will complete recruitment as detailed above.
Each participant will be given between 24hours and 1 week to decide whether to participate.
Researchers will first meet with care staff informed of the study at each centre to discuss their own consent and provide consent form to them. At this point only risk information for each client will be discussed with the care staff with the purpose of ensuring the safety of both the clients and researchers at first point of contact.
Researchers will meet with recruited clients individually to discuss consent and complete questionnaires.
Researchers will again meet with care staff to discuss client demographic information and to complete one questionnaire, if clients have consented for this to take place.
The trained psychology staff will provide 6 weeks of ACT training to clients in the treatment group weekly. Each group will have up to 4 clients per group.
Researchers will meet with both groups after this time period to repeat testing of the questionnaires with both staff.
Details concerning what treatments, aside from ACT, were provided to each client during the 6 week period will be collected from case files and through discussion with staff.
Clients at all centres will be invited to take part in a focus group at this time to discuss their participation in the study.
Care staff at the intervention centre will be invited to participate in a focus group.
Psychology staff at the intervention centre will be invited to participate in a focus group and complete a questionnaire.
Further research tasks to be completed by staff:
Any observations as part of applying the study protocol will also be documented. For example, the participant flow, drop out rates, the administration of questionnaires, the storage of materials and ethical issues will all be commented upon as per the objective of the overall pilot study.
Guidelines for reporting Serious Adverse Events (SAEs) will be piloted as part of this study. In order to establish base rates for this group, a record will be kept of any SAE experience by participants of intervention or comparison group. A checklist of potential SAEs will be used at both times of testing for treatment and control group in order to establish whether any SAEs occurred.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Acceptance and Commitment Therapy, Treatment as Usual
- Keywords
- Acceptance and Commitment Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
A psychotherapeutic intervention that aims to enhance individuals' willingness to have difficult experiences but persist with behaviours that reflect what is important to them.
Treatment as UsualBehavioural
A client-centred goal planning system linked to community reintegration and based on a holistic rehabilitation model including counselling, medical management, cognitive behavioural therapy and pharmacotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Treatment as Usual and Acceptance \& Commitment Therapy Receives: Behavioral: Acceptance and Commitment Therapy; Behavioral: Treatment as Usual |
| Comparison group | Other | Treatment as Usual Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of ACT as measured by focus-group discussions with clients and staff; number of participants withdrawing from study
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants withdrawing from study
Measured: 9 weeks
Suitability of ACT as measured by Acceptance and Action Questionnaire - Acquired Brain Injury
Quantitative comparison between groups of results of Acceptance and Action Questionnaire - Acquired Brain Injury
Measured: 9 weeks
Feasibility of ACT as measured by focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
Measured: 9 weeks
Secondary outcomes (3)
Suitability of ACT, as measured by Hospital Anxiety and Depression Scale
Quantitative comparison between groups of results of the Hospital Anxiety and Depression Scale
Measured: 9 weeks
Suitability of ACT as measured by the Motivation for Traumatic Brain Injury Rehabilitation Questionnaire
Quantitative comparison between groups of results of Motivation for Traumatic Brain Injury Rehabilitation Questionnaire
Measured: 9 weeks
Suitability of ACT as measured by Awareness Questionnaire
Quantitative comparison between groups of results of Awareness Questionnaire
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Responsible party
- Principal investigator, Hamish J McLeod PhD CPsychol, University of Glasgow
- Investigators
- Hamish McLeod, PhD CPsychol, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337114
- Sponsor's protocol ID
- 14/WS/1152
- Acronym
- REACT
- Status last verified
- Dec 2015
- First submitted
- 12 Dec 2014
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACT - Recovery Enhancement From TBI Using ACT. A Pilot Study.
- ClinicalTrials.gov ID
- NCT02337114
- Acronym / sponsor ID
- REACT / 14/WS/1152
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Acceptance and Commitment Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Psychological intervention may facilitate this change; however what works is unclear. ACT seeks to improve psychological flexibility; the ability to be present with difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what we believe we should be. Current research is limited, but what is published suggests it may be useful for this group.
Due to the limited research this pilot study aims to conduct preliminary analysis on the acceptability and feasibility of ACT for people with sTBI whilst also examining the suitability of the study protocol in order to make recommendations for future studies. Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be recruited, one of which will serve as the intervention centre.
Clients in the intervention group will be asked to complete questionnaires a week before and after participation in the 6 week ACT programme. Clients in the comparison group will be asked to complete questionnaires a week before and after receiving 6 weeks of treatment as usual (TAU). The treatment group will also receive TAU. All participants will be invited to participate in a focus group at the end of this 8 week period to discuss their involvement in the study.
Staff will be asked to complete a parallel version of one of the client questionnaires within a similar timeframe. In addition staff at the intervention centre will be invited to attend a focus group and complete an additional questionnaire after the eight week period.
Detailed description
A pilot study design will initially assess the feasibility and acceptability of the ACT and study protocol with this client group in order to inform a future clinical trial.
The methodology involves both quantitative and qualitative methods and will involve inpatients at Brain Injury Rehabilitation Trust (BIRT) units, staff involved in the day to day care of inpatients and clinicians involved in the administration of therapy. Quantitative methods (questionnaires) were chosen to assess any possible change in assessment measures. The measures chosen have been previously used. They have good validity (the ability to answer the questions asked) and reliability, and therefore are practically suitable for measuring outcomes of therapy. Qualitative methods (focus groups) were also chosen, owing to the pilot nature of this research, in order to obtain personal opinion on the acceptability of the intervention and the treatment protocol, from those participating.
The intervention will be administered, alongside TAU, to inpatients at a BIRT centre in Glasgow and will be compared to a comparison group which will receive TAU only (who will be based in BIRT centres in either York and/or Leeds). The rational for choosing a BIRT centre in Glasgow for the intervention group is one of convenience as all researchers involved in the study are based in Glasgow. This will help facilitate data collection and reduce cost. Given that all BIRT centres adhere to a similar philosophy of care and rehabilitation and service user profiles are relatively similar, it was believed that recruiting elsewhere for the purpose of comparison would be appropriate. Recruiting treatment and comparison groups from separate centres also ensures that clients receiving TAU only do not learn ACT strategies accidentally through discussion with peers or staff. If this were to happen any indication of change could not be attributed to the difference in treatments provided.
Five participant groups will be recruited:
- clients in the inpatient setting (treatment group),
- clients in the inpatient setting (comparison group),
- care staff working directly with clients (treatment group),
- care staff working directly with clients (comparison group)
- psychology staff involved in administering the intervention.
All participants will be provided with an information sheet and consent will be sought prior to their participation in the study. All interventions, assessments and focus groups will be completed at the participants respective centres. All recruitment, with the exception of the psychology staff who are a convenient sample, will be conducted by a staff member not involved in the direct write up of the study. Further to this all outcome measures and focus groups will be conducted by researchers not involved in the provision of treatment.
Psychology staff at the intervention centre who have completed training on ACT will be further informed of the study. If they choose to participate they will recruit clients at BIRT in Glasgow, completing a record form identifying inclusion and exclusion criteria met. This form will allow the staff to outline any barriers or difficulties encountered as part of this process. Information sheets will then be provided to recruited clients, in addition to care staff who work with them.
The study will also be explained to heads of service at each of the comparison sites, providing them both with an integrated protocol. They will identify a point of contact who will complete recruitment as detailed above.
Each participant will be given between 24hours and 1 week to decide whether to participate.
Researchers will first meet with care staff informed of the study at each centre to discuss their own consent and provide consent form to them. At this point only risk information for each client will be discussed with the care staff with the purpose of ensuring the safety of both the clients and researchers at first point of contact.
Researchers will meet with recruited clients individually to discuss consent and complete questionnaires.
Researchers will again meet with care staff to discuss client demographic information and to complete one questionnaire, if clients have consented for this to take place.
The trained psychology staff will provide 6 weeks of ACT training to clients in the treatment group weekly. Each group will have up to 4 clients per group.
Researchers will meet with both groups after this time period to repeat testing of the questionnaires with both staff.
Details concerning what treatments, aside from ACT, were provided to each client during the 6 week period will be collected from case files and through discussion with staff.
Clients at all centres will be invited to take part in a focus group at this time to discuss their participation in the study.
Care staff at the intervention centre will be invited to participate in a focus group.
Psychology staff at the intervention centre will be invited to participate in a focus group and complete a questionnaire.
Further research tasks to be completed by staff:
Any observations as part of applying the study protocol will also be documented. For example, the participant flow, drop out rates, the administration of questionnaires, the storage of materials and ethical issues will all be commented upon as per the objective of the overall pilot study.
Guidelines for reporting Serious Adverse Events (SAEs) will be piloted as part of this study. In order to establish base rates for this group, a record will be kept of any SAE experience by participants of intervention or comparison group. A checklist of potential SAEs will be used at both times of testing for treatment and control group in order to establish whether any SAEs occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Acceptance and Commitment Therapy, Behavioral: Treatment as UsualTreatment as Usual and Acceptance \& Commitment Therapy |
| Comparison group | Other | Behavioral: Treatment as UsualTreatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- have sustained a severe TBI after the age of 18; indicated by presence of posttraumatic amnesia for a day or more OR loss of consciousness for 30 minutes or more following injury OR scores of eight or less on the Glasgow Coma Scale.
- have sufficient English language skills to enable valid participation using standard tests and questionnaires
- be admitted to BIRT for neuropsychological rehabilitation
- have sufficient cognitive capacity to complete questionnaires independently and participate in discussions as part of the ACT intervention.
- completed 1.5 day ACT training
Key exclusion criteria (11 listed)
- lack capacity to consent to participate in research as assessed by staff at BIRT or by the researcher when discussing consent with the participant
- will remain in the unit for less than eight weeks
- have challenging behaviour that may put the researcher or participant at risk or prevent participation in the study.
- they have not received the appropriate training
- they consider that do not have the time and resources to partake in all the research tasks.
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 TherapyA psychotherapeutic intervention that aims to enhance individuals' willingness to have difficult experiences but persist with behaviours that reflect what is important to them. | Behavioural | Intervention group |
| Treatment as UsualA client-centred goal planning system linked to community reintegration and based on a holistic rehabilitation model including counselling, medical management, cognitive behavioural therapy and pharmacotherapy. | Behavioural | Comparison group, Intervention group |
Primary outcome
Acceptability of ACT as measured by focus-group discussions with clients and staff; number of participants withdrawing from study
Time frame: 9 weeks
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants withdrawing from study
Suitability of ACT as measured by Acceptance and Action Questionnaire - Acquired Brain Injury
Time frame: 9 weeks
Quantitative comparison between groups of results of Acceptance and Action Questionnaire - Acquired Brain Injury
Feasibility of ACT as measured by focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
Time frame: 9 weeks
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
3 secondary outcomes
Suitability of ACT, as measured by Hospital Anxiety and Depression Scale
Time frame: 9 weeks
Suitability of ACT as measured by the Motivation for Traumatic Brain Injury Rehabilitation Questionnaire
Time frame: 9 weeks
Suitability of ACT as measured by Awareness Questionnaire
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
Hamish McLeod, PhD CPsychol principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acceptance and Commitment Therapy and Treatment as Usual in people with Brain Injuries, Traumatic, run by University of Glasgow at 1 site 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 16 inclusion and 11 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: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of ACT as measured by focus-group discussions with clients and staff; number of participants withdrawing from study (time frame: 9 weeks). The study lists 3 primary outcomes in all. 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 10 Dec 2015.