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OpenTrials
Completed

NCT Number: NCT01867684

Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

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.

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Emotional Distress Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Other

Primary outcomes

  1. Recruitment rate at 20 weeks from baseline

    Time frame: 20 weeks

  2. Treatment adherence at 20 weeks from baseline

    Time frame: 20 weeks

  3. Sample retention at 20 weeks from baseline

    Time frame: 20 weeks

Secondary outcomes

  1. Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires

    Time frame: 1 week

  2. Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline

    Time frame: 20 weeks

  3. Changes in AHI scores at 20 weeks from baseline

    Time frame: 20 weeks

  4. Likert ratings of participants and therapists experiences of treatment delivery

    Time frame: 8 weeks

  5. Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline

    Time frame: 20 weeks

  6. Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

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

Acronym: PoPsTAR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Jan 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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