Wellness Programs for Brain-Injured Individuals

NCT02600637 | Completed Results

• 1 other identifier: D1893-P
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Thousands of Veterans suffer a stroke every year, and these individuals often suffer emotional and cognitive changes that negatively affect their quality of life as well as their ability to recover. In addition to traditional rehabilitation such as physical and occupational therapy, a number of alternative treatments are now being studied for their ability to enhance patients' recovery following stroke. One of these treatments, Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches individuals strategies such as breathing techniques, meditation, and movement therapy. The current pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to determine whether this type of intervention is feasible, acceptable to patients, and shows preliminary evidence of beneficial effects on psychological and cognitive functioning. The investigators hope to find that MBSR is a useful, additional intervention that can improve Veterans' well-being and quality of life as they recover from stroke.

Conditions

Depression; Anxiety; Stroke

Keywords

stroke; depression; anxiety; mindfulness; meditation

Outcome Measures

Primary Outcomes (2)

• Depression Score Change on Geriatric Depression Scale

  Determine whether the MBSR treatment has any effect on depression by comparing change scores (post-intervention minus pre-intervention) on the Geriatric Depression Scale (GDS) for MBSR versus Education control group. A negative change score indicates improvement in depressive symptomatology. Full score range possible on the GDS is 0-30, where 0 means no depression and 30 means severe depression.

  Over the 8 week assessment period for each participant, up to a total of 5 months

• Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire

  Determine whether the MBSR treatment has any effect on anxiety by comparing change score (post-intervention minus pre-intervention) on State-Trait Anxiety Inventory (STAI) for MBSR versus Education control group. A negative change score indicates improvement in anxiety symptoms. Full range of scores on the STAI is 20-80, where 20 is minimal/no anxiety and 80 is severe anxiety.

  Over the 8 week assessment period for each participant, up to a total of 5 months

Secondary Outcomes (1)

• Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score

  Over the 8 week assessment period for each participant, up to a total of 5 months

Study Arms (2)

MBSR

EXPERIMENTAL

Mindfulness-based Stress Reduction program

Behavioral: MBSR

Education

ACTIVE COMPARATOR

Educational group program

Behavioral: Brain Health class

Interventions

MBSR BEHAVIORAL

Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.

Also known as: Meditation

MBSR

Brain Health class BEHAVIORAL

An 8-week course on brain health will be administered to participants as an active control group.

Also known as: Psychoeducation

Education

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of a single, chronic right or left hemisphere stroke (\> 6 months post-onset so that residual symptoms have stabilized)
• Age 20-80
• Native English proficiency
• At least mild level of depression and/or mild anxiety
• Language within normal limits so that language deficits will not interfere with the intervention

You may not qualify if:

• A pre-morbid neurologic history or history of schizophrenia spectrum and other psychotic disorders
• Bipolar disorders
• Depressive disorders with psychotic features (to avoid potential confounds in neuropsychological testing)
• Mini-Mental State Examination score \<19 (suggesting moderate to severe cognitive impairment that is a contraindication in effectively participating in the MBSR intervention52)
• Recent substance abuse/dependence disorder (\< 1 year)
• Acutely suicidal (defined below)
• Concurrent involvement in another rehabilitation program
• Significant visual or hearing disabilities that would preclude participating in the program
• Medical history, including pre-morbid neurologic and psychiatric history, will be assessed with a standard medical questionnaire during the initial interview session as well as a review of patients' VA medical records

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stroke

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Juliana Baldo
• Organization: VA Northern California

juliana.baldo@va.gov

925-372-4649

Study Officials

• Juliana V. Baldo, PhD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: April 10, 2018
• Study Completion: June 30, 2018
• Last Updated: July 24, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-07

Locations

US (1)