Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms

NCT03293797 | Unknown

• 1 other identifier: 387-2015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility / efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of this controlled study is to further test feasibility and acceptability of this intervention to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to accessing mental health care.

Conditions

Anxiety; Depression; Mood

Keywords

Mindfulness-based Therapy; Wellbeing; Treatment

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Depressive Symptoms at 5 Week

  Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)

  Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)

• Change from Baseline Anxiety Symptoms at 5 Week

  Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)

  Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)

Secondary Outcomes (2)

• Change from Baseline Mental Wellbeing at 5 Week

  Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)

• Change from Baseline Self-Compassion at 5 Week

  Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]

Study Arms (1)

Abbreviated Mindfulness-based Therapy

EXPERIMENTAL

5 week, abbreviated group MBT treatment for depression and anxiety

Behavioral: Abbreviated-Mindfulness-based Therapy

Interventions

Abbreviated-Mindfulness-based Therapy BEHAVIORAL

A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.

Also known as: A-MBT

Abbreviated Mindfulness-based Therapy

Eligibility Criteria

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

You may qualify if:

• Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic

You may not qualify if:

• Patients who have active or recent (within 3 months) substance abuse/dependence, a history of dementia, untreated posttraumatic stress symptoms, active psychotic or manic symptoms, recent suicide attempt/active suicidality, or current self-injurious behaviour
• Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the last 3 years

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Steven Selchen, MD MSt FRCPC

  Sunnybrook Healthy Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Diplock, BSc MAc

CONTACT

416-480-6100; ben.diplock@sunnybrook.ca

Steven Selchen, MD MSt FRCPC

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

CA (1)