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CompletedNCT01867684PoPsTARUpdated Jan 8, 2015

Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

An interventional study of Psychotherapy in Acquired Brain Injury and Emotional Distress, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-08.

Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Acquired Brain Injury
  • Emotional Distress

Keywords

  • Stroke
  • Acquired brain injury
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 37 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • 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

Interventions

  • OtherPsychotherapy
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What researchers measure

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

07

Study locations

1 site
  • NHS Greater Glasgow and Clyde
    Glasgow, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01867684
Lead sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
Responsible party
Sponsor
First posted
Jun 4, 2013
Start date
Jul 2013
Primary completion
May 2014
Completion
Oct 2014
Last update
Jan 8, 2015

Study contacts

Jonathan Evans, PhD
principal investigator · University of Glasgow

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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