Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

NCT01867684 | Completed

• 2 other identifiers: GN12CP391CZH/4/778
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acquired Brain Injury; Emotional Distress

Keywords

Stroke; Acquired brain injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

Treatment as usual

NO INTERVENTION

Standard NHS care for the patient group (NHS care will vary as participants will be recruited from a variety of NHS clinics).

Psychotherapy

EXPERIMENTAL

Brief psychotherapy intervention delivered over 8 weeks in addition to standard care.

Other: Psychotherapy

Interventions

Psychotherapy OTHER

Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries; Stroke

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Jonathan Evans, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: June 4, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

GB (1)