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Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation (PoPsTAR)

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ClinicalTrials.gov Identifier: NCT01867684
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : January 8, 2015
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.

Condition or disease Intervention/treatment Phase
Acquired Brain Injury Emotional Distress Other: Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
No Intervention: Treatment as usual
Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics).
Experimental: Psychotherapy
Brief psychotherapy intervention delivered over 8 weeks in addition to standard care.
Other: Psychotherapy



Primary Outcome Measures :
  1. Recruitment rate at 20 weeks from baseline [ Time Frame: 20 weeks ]
  2. Treatment adherence at 20 weeks from baseline [ Time Frame: 20 weeks ]
  3. Sample retention at 20 weeks from baseline [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires [ Time Frame: 1 week ]
  2. Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline [ Time Frame: 20 weeks ]
  3. Changes in AHI scores at 20 weeks from baseline [ Time Frame: 20 weeks ]
  4. Likert ratings of participants and therapists experiences of treatment delivery [ Time Frame: 8 weeks ]
  5. Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline [ Time Frame: 20 weeks ]
  6. Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline [ Time Frame: 20 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867684


Locations
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United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Jonathan Evans, PhD University of Glasgow
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01867684    
Other Study ID Numbers: GN12CP391
CZH/4/778 ( Other Grant/Funding Number: Chief Scientist Office )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by NHS Greater Glasgow and Clyde:
Stroke
Acquired brain injury
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System