Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

NCT ID: NCT01867684

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychotherapy

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

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: OTHER

Interventions

Psychotherapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

CZH/4/778

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GN12CP391

Identifier Type: -

Identifier Source: org_study_id