Acquired Brain InjuryPoPsTARNCT01867684
Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation
A study testing Psychotherapy in people with Acquired Brain Injury and Emotional Distress, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Emotional Distress
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Oct 2014
- 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 18 years or over;
- Diagnosis of stroke or acquired brain injury (confirmed clinically and/or radiologically);
- Between 3 and 12 months post-injury at time of recruitment;
- Presence of emotional distress (score in moderate or above range on at least one sub-scale of the Depression Anxiety Stress Scales; DASS-21);
- Medically stable;
- Able to consent to research.
Who cannot join
- Significant communication impairments that would preclude participation;
- Diagnosis of mild traumatic brain injury (due to the known additional complexities contributing to outcome in this population);
- Comorbid developmental learning disability or degenerative neurological condition.
- Pre-injury history of mood disorder will not lead to exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.
- Conditions
- Acquired Brain Injury, Emotional Distress
- Being tested
- Psychotherapy
- Keywords
- Stroke, Acquired brain injury
- Medical subject headings
- Brain Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics). |
| Psychotherapy | Experimental | Brief psychotherapy intervention delivered over 8 weeks in addition to standard care. Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate at 20 weeks from baseline
Measured: 20 weeks
Treatment adherence at 20 weeks from baseline
Measured: 20 weeks
Sample retention at 20 weeks from baseline
Measured: 20 weeks
Secondary outcomes (6)
Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires
Measured: 1 week
Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline
Measured: 20 weeks
Changes in AHI scores at 20 weeks from baseline
Measured: 20 weeks
Likert ratings of participants and therapists experiences of treatment delivery
Measured: 8 weeks
Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline
Measured: 20 weeks
Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jonathan Evans, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867684
- Sponsor's protocol ID
- GN12CP391
- Other IDs
- CZH/4/778
- Acronym
- PoPsTAR
- Status last verified
- Jan 2015
- First submitted
- 20 May 2013
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01867684
- Acronym / sponsor ID
- PoPsTAR / GN12CP391
- Conditions
- Acquired Brain Injury, Emotional Distress
- Keywords
- Stroke, Acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Jun 2013 (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.
Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics). |
| Psychotherapy | Experimental | Other: PsychotherapyBrief psychotherapy intervention delivered over 8 weeks in addition to standard care. |
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 18 years or over;
- Diagnosis of stroke or acquired brain injury (confirmed clinically and/or radiologically);
- Between 3 and 12 months post-injury at time of recruitment;
- Presence of emotional distress (score in moderate or above range on at least one sub-scale of the Depression Anxiety Stress Scales; DASS-21);
- Medically stable;
Key exclusion criteria (4 listed)
- Significant communication impairments that would preclude participation;
- Diagnosis of mild traumatic brain injury (due to the known additional complexities contributing to outcome in this population);
- Comorbid developmental learning disability or degenerative neurological condition.
- Pre-injury history of mood disorder will not lead to exclusion.
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 |
|---|---|---|
| Psychotherapy | Other | Psychotherapy |
Primary outcome
Recruitment rate at 20 weeks from baseline
Time frame: 20 weeks
Treatment adherence at 20 weeks from baseline
Time frame: 20 weeks
Sample retention at 20 weeks from baseline
Time frame: 20 weeks
6 secondary outcomes
Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires
Time frame: 1 week
Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline
Time frame: 20 weeks
Changes in AHI scores at 20 weeks from baseline
Time frame: 20 weeks
Likert ratings of participants and therapists experiences of treatment delivery
Time frame: 8 weeks
Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline
Time frame: 20 weeks
Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline
Time frame: 20 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 8 Jan 2015.
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Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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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.
Jonathan Evans, PhD 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 study testing Psychotherapy in people with Acquired Brain Injury and Emotional Distress, run by NHS Greater Glasgow and Clyde 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 6 inclusion and 4 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 8 Jan 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.
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?
Recruitment rate at 20 weeks from baseline (time frame: 20 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 8 Jan 2015.