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Clinical Trials/NCT01867684
NCT01867684
Completed
Not Applicable

Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial

NHS Greater Glasgow and Clyde1 site in 1 country37 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
37
Locations
1
Primary Endpoint
Sample retention at 20 weeks from baseline
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Sample retention at 20 weeks from baseline

Time Frame: 20 weeks

Recruitment rate at 20 weeks from baseline

Time Frame: 20 weeks

Treatment adherence at 20 weeks from baseline

Time Frame: 20 weeks

Secondary Outcomes

  • Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires(1 week)
  • Likert ratings of participants and therapists experiences of treatment delivery(8 weeks)
  • Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline(20 weeks)
  • Changes in AHI scores at 20 weeks from baseline(20 weeks)
  • Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline(20 weeks)
  • Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline(20 weeks)

Study Sites (1)

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