Testing mindfulness-based therapy for depression symptoms
Affective Executive Functioning as a Mechanism of Treatments for Depression Symptoms
NA · Butler Hospital · NCT05585775
This study is testing if an 8-week mindfulness therapy can help adults with depression feel better and improve their thinking skills compared to a wellness program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Butler Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05585775 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of Mindfulness-Based Cognitive Therapy (MBCT) compared to a Wellness for Wellbeing program on various aspects of affective executive functioning in adults with elevated depression symptoms. The study will utilize a randomized controlled trial design, recruiting 76 participants who will undergo either an 8-week MBCT course or a Wellness for Wellbeing class. Participants will complete validated computer-based tasks to measure affective inhibition, updating, and shifting at multiple time points throughout the intervention. The study also seeks to explore the relationship between depression symptom severity and changes in executive functioning over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to moderate depression symptoms who have not previously engaged in mindfulness-based treatments.
Not a fit: Patients with severe depression symptoms, psychotic symptoms, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how mindfulness-based therapies impact cognitive processes in individuals with depression, potentially leading to improved treatment strategies.
How similar studies have performed: Previous studies have shown promising results for mindfulness-based interventions in treating depression, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18 years or older 2. English fluency in order to complete study procedures 3. Normal vision or corrected to normal vision 4. QIDS score ≥ 5 and ≤ 15 to include individuals with elevated, but not severe symptoms of depression 5. No presence of psychotic symptoms that interfere with functioning 6. No current hazardous alcohol or drug use 7. No previous experience with mindfulness-based treatment (i.e., enrollment in MBSR or MBCT previously) 8. No current symptoms of mania indicative of a manic episode 9. No current cognitive impairment 10. No history of a formally diagnosed learning disability in reading, intellectual disability or other developmental disorder 11. No history of a neurologic illness affecting cognition 12. If on psychiatric medications, no change in medications for at least 4 weeks 13. If in psychotherapy, no change in therapy status for at least 4 weeks Exclusion Criteria: Exclusion criteria include: (a) presence of psychotic symptoms that interfere with one's ability to function as determined by the SCID-5 Psychotic Screening Module; (b) current hazardous alcohol or drug use as indicated by a score of \>10 for men and women on the AUDIT and the DUDIT for cannabis use, and \>6 for men and women on the DUDIT for all other drugs (everything but cannabis), (c) change in psychiatric drug prescription within 4 weeks; (d) started psychotherapy or other psychiatric treatment within the past 4 weeks; (e) current suicide ideation or behavior which requires urgent intervention due to safety concerns; (f) Previous enrollment in MBCT or MBSR; (g) symptoms of mild cognitive impairment as indicated by a score of \<26 on the MoCA; (h) formally diagnosed learning disability, intellectual disability, or other developmental disorder; (i) history of neurologic illness affecting cognition; (j) current symptoms indicative of a manic episode per the SCID-5 Mood Disorders Module.
Where this trial is running
Providence, Rhode Island
- Butler Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Morganne Kraines, PhD — Butler Hospital
- Study coordinator: Morganne Kraines, PhD
- Email: MKraines@carene.org
- Phone: 401-455-6626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression in Remission, Depressive Symptoms, Depression