Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

Acquired Brain Injury Clinical Trial

— PoPsTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867684
• Other study ID #: GN12CP391
• Secondary ID: CZH/4/778
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: January 7, 2015
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Emotional Distress

Intervention

Other:
• Psychotherapy

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate at 20 weeks from baseline		20 weeks	No
Primary	Treatment adherence at 20 weeks from baseline		20 weeks	No
Primary	Sample retention at 20 weeks from baseline		20 weeks	No
Secondary	Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires		1 week	No
Secondary	Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline		20 weeks	No
Secondary	Changes in AHI scores at 20 weeks from baseline		20 weeks	No
Secondary	Likert ratings of participants and therapists experiences of treatment delivery		8 weeks	No
Secondary	Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline		20 weeks	No
Secondary	Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline		20 weeks	No