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

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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Emotional Distress
• Intervention / Treatment: Other: Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Jonathan Evans, PhD, University of Glasgow

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Acquired brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: GN12CP391; CZH/4/778 (Other Grant/Funding Number: Chief Scientist Office)