Cognition in Mindfulness: Negativity and Depression

NCT05802966 | Terminated

• 1 other identifier: NL68398.091.18
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates and (residual) symptoms in major depressive disorder (MDD). However, the mechanisms underlying those MBCT-induced effects are far from clear. The goal of this study is to get more insight into the working mechanisms of MBCT. The main question to be answered is whether MBCT-induced reduction in depressive symptoms is mediated and/or moderated by repetitive negative thinking (RNT), or other factors hypothesized to be involved in the working mechanism of MBCT (e.g. mindfulness skills and self-compassion).

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Mindfulness-Based Cognitive Therapy; Working mechanisms

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  Measured with the Inventory of Depressive Symptomatology Self-Report (IDS-SR). The IDS-SR consists of 30 items. Scores range from 0-84. Higher scores indicate a higher severity of depression.

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Depressive rumination

  Measured with the brooding subscale of the Ruminative Response Scale (RRS). The brooding subscale consists of 5 items. Scores range from 5-20. Higher scores indicate a higher level of depressive rumination.

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Repetitive negative thinking (RNT)

  Measured by the Perseverative Thinking Questionnaire (PTQ). The PTQ consists of 15 items. Scores range from 0-60. Higher scores indicate a higher level of repetitive negative thinking.

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

Secondary Outcomes (7)

• Intrusive thoughts (state measure)

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Mindfulness Skills

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Anxiety Symptoms

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Overall functioning

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

• Self-compassion

  Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

Other Outcomes (3)

• Depressive symptoms

  Week-to-week change assessed after each MBCT session (up to 8 weeks) or weekly during wait-list (up to 8 weeks)

• Non-judging mindfulness skill

  Week-to-week change assessed after each MBCT session (up to 8 weeks) or weekly during wait-list (up to 8 weeks)

• Depressive rumination

  Week-to-week change assessed after each MBCT session (up to 8 weeks) or weekly during wait-list (up to 8 weeks)

Study Arms (2)

Mindfulness-Based Cognitive Therapy + Treatment as usual

Patients receive Mindfulness-Based Cognitive Therapy (MBCT) and treatment as usual (TAU). Measurements are administered before, half-way and after MBCT.

Behavioral: Mindfulness-Based Cognitive Therapy

Wait-list control (Treatment as usual)

Patients in the wait-list controlled group receive treatment us usual (TAU) during their waiting-period. After their waiting period, they receive MBCT in a similar fashion compared to the intervention group. Measurements are administered before, half-way and after their waiting period. In addition, a fourth and fifth measurement will be administered half-way and after MBCT.

Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

MBCT will be offered according to the MBCT manual developed for relapse prevention in MDD (Zindel V. Segal, Williams, \& Teasdale, 2002). Thus, MBCT will consist of 8-weekly sessions of 2,5 hours, a 6-hour silent day, and daily home practice (± 45min). MBCT will be taught by a certified MBCT teacher meeting the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders (Belgium) which are in concordance with the Good Practice guidelines of the UK Network of Mindfulness-Based Teacher Trainers (Crane et al., 2012).

Mindfulness-Based Cognitive Therapy + Treatment as usual; Wait-list control (Treatment as usual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic or recurrent MDD who are referred for MBCT at the RadboudUMC Centre for Mindfulness or at different locations of a local mental health institute (Pro Persona) will be recruited for the current study. Those patients will follow regular medical intake-procedures in accordance to procedures at the respective institutes and are screened for chronic or recurrent depression and other in- and exclusion criteria. Depression will be considered chronic if patients meet the DSM-V criteria of a 'persistent depressive disorder', which is combination of the 'chronic depressive disorder' and 'dysthymic disorder' as defined in the DSM-IV.

You may qualify if:

• age ≥ 18
• diagnosis of chronic or recurrent MDD according to DSM-V criteria, both current or remitted
• able to give informed consent and perform experimental tasks

You may not qualify if:

• in remission of first (not chronic) episode or having a first (not chronic) current episode
• insufficient comprehension of the Dutch language
• physical, cognitive, or intellectual impairments interfering with participation such as deafness, blindness, or sensorimotor handicaps
• formerly involved in MBCT or MBSR or other 8-week Mindfulness-Based Intervention (MBI)
• meets criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective illness or anorexia nervosa
• current psychosis
• high level of suicidality
• drug or alcohol addiction in the past 6 months.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Pro Persona Mental Health Care Foundation: collaborator

Study Sites (2)

Pro Persona

Nijmegen, Gelderland, 6503CG, Netherlands

Location

Radboud University Medical Centre

Nijmegen, Gelderland, P.O. Box 9101, Netherlands

Location

Related Publications (1)

• Lubbers J, Geurts DEM, Spinhoven P, Cladder-Micus MB, Ennen D, Speckens AEM, Spijker J. Rumination and Self-Compassion Moderate Mindfulness-Based Cognitive Therapy for Patients With Recurrent and Persistent Major Depressive Disorder: A Controlled Trial. Depress Anxiety. 2024 Nov 25;2024:3511703. doi: 10.1155/da/3511703. eCollection 2024.

  PMID: 40226644 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 7, 2023
• Study Start: June 24, 2019
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: The final report of the primary endpoint (assesment of whether MBCT-induced change in depressive symptoms is mediated by change in RNT) is expected December 2023.
• Access Criteria: Restricted access. Meaning that interested researchers are welcome to contact us (authors) or the data-manager of the radboud data repository with requests for data. A team consisting of a data-manager and researchers will review the quality of the request and grant permission of the request is in accordance with the terms of use drafted by the Radboudumc and Radboud University.

Locations

NL (2)