Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation (PoPsTAR)
Primary Purpose
Acquired Brain Injury, Emotional Distress
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Stroke, Acquired brain injury
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- NHS Greater Glasgow and Clyde
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as usual
Psychotherapy
Arm Description
Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics).
Brief psychotherapy intervention delivered over 8 weeks in addition to standard care.
Outcomes
Primary Outcome Measures
Recruitment rate at 20 weeks from baseline
Treatment adherence at 20 weeks from baseline
Sample retention at 20 weeks from baseline
Secondary Outcome Measures
Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires
Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline
Changes in AHI scores at 20 weeks from baseline
Likert ratings of participants and therapists experiences of treatment delivery
Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline
Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline
Full Information
NCT ID
NCT01867684
First Posted
May 20, 2013
Last Updated
January 7, 2015
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT01867684
Brief Title
Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation
Acronym
PoPsTAR
Official Title
Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Emotional Distress
Keywords
Stroke, Acquired brain injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics).
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Brief psychotherapy intervention delivered over 8 weeks in addition to standard care.
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Primary Outcome Measure Information:
Title
Recruitment rate at 20 weeks from baseline
Time Frame
20 weeks
Title
Treatment adherence at 20 weeks from baseline
Time Frame
20 weeks
Title
Sample retention at 20 weeks from baseline
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires
Time Frame
1 week
Title
Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline
Time Frame
20 weeks
Title
Changes in AHI scores at 20 weeks from baseline
Time Frame
20 weeks
Title
Likert ratings of participants and therapists experiences of treatment delivery
Time Frame
8 weeks
Title
Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline
Time Frame
20 weeks
Title
Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Evans, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation
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