Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

Study Overview
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Brief Summary
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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.

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

Conditions
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Acquired Brain Injury, Emotional Distress

Intervention / Treatment
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* Other: Psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate at 20 weeks from baseline |  | 20 weeks | 
| Treatment adherence at 20 weeks from baseline |  | 20 weeks | 
| Sample retention at 20 weeks from baseline |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires |  | 1 week | 
| 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 | 
| Likert ratings of participants and therapists experiences of treatment delivery |  | 8 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Acquired brain injury