Clinical trial NCT01867684: Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation
Official title: Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Emotional Distress
Keywords: Stroke
Acquired brain injury
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2013-06-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recruitment rate at 20 weeks from baseline
timeFrame: 20 weeks
measure: Treatment adherence at 20 weeks from baseline
timeFrame: 20 weeks
measure: Sample retention at 20 weeks from baseline
timeFrame: 20 weeks
Secondary outcomes:
measure: Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires
timeFrame: 1 week
measure: Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline
timeFrame: 20 weeks
measure: Changes in AHI scores at 20 weeks from baseline
timeFrame: 20 weeks
measure: Likert ratings of participants and therapists experiences of treatment delivery
timeFrame: 8 weeks
measure: Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline
timeFrame: 20 weeks
measure: Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: University of Glasgow
name: Jonathan Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: