The Efficacy of Mindfulness-Based Cognitive Therapy on Rumination and Emotion Regulation in Patients with Anxiety and Depression
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 40 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population of the study will be all employed women referring to Rayan counseling centers in Ahvaz during the period of June 2026. In the sample selection stage, convenience sampling method will be used. After selecting the samples to a volume of 40 people, based on the research entry and exit criteria, the participants will be randomly assigned to two groups: "Mindfulness-Based Cognitive Behavioral Therapy" (intervention group) and "Waiting List" (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged between 30 and 40 years, diagnosed with anxiety, depression, or anxiety-depression comorbidity based on a clinical interview or validated questionnaire, experiencing frequent rumination (according to questionnaire score or self-report)
Exclusion criteria: Unwillingness to participate in the study, concurrent participation in other active psychological treatments
Intervention groups
Intervention group: All individuals who will receive mindfulness-based cognitive-behavioral therapy.
Control group: All individuals who will not receive any intervention.
The Efficacy of Mindfulness-Based Cognitive Therapy (MBCT) on Rumination and Emotion Regulation in Patients with Anxiety and Depression
Public title
Investigating the effect of mindfulness training on improving mental health in people with anxiety and depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women in their 30s and 40s
Diagnosis of anxiety, depression, or anxiety-depression comorbidity based on a clinical interview or validated questionnaire
Score above the cutoff on standard depression or anxiety questionnaires
Experience of frequent rumination as measured by questionnaire score or self-report
Exclusion criteria:
Unwillingness to participate in research
Concurrent participation in other active psychological therapies
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of the study will comprise all employed women attending counseling center during the period of June 2026. In this type of effectiveness study, a two-stage approach is typically used: in the sampling stage, convenience sampling is employed. After selecting a sample of 40 participants, based on the study’s inclusion and exclusion criteria, participants will be randomly assigned to two groups: “Mindfulness-Based Cognitive Behavioral Therapy” (intervention group) and “Waiting List” (control group). Randomization will be performed using permuted random blocks with variable sizes (4 and 6 participants) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and sequentially numbered envelopes to ensure the researcher and participants remain unaware of the allocation sequence (allocation concealment). The envelope will be opened, and the assigned group will be revealed only at the time each participant enters the study. To ensure baseline equivalence of variables (such as anxiety level and age), their distribution between the two groups will be examined during the statistical analysis phase.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz Branch
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The variable will be measured using the Nolen-Hoeksma and Maru (1991) rumination questionnaire.
2
Description
Emotion Regulation
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The variable will be measured using the Gross and John (2003) emotion regulation questionnaire.
3
Description
Anxiety
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The variable will be measured using the Beck et al. (1988) anxiety scale.
4
Description
Depression
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The variable will be measured using the Beck et al. (1996) Depression Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness-Based Cognitive Behavioral Therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions, Session sequence: Twice a week; Key therapeutic tools: This intervention focuses on mindfulness, acceptance, emotional regulation, and coping with rumination. Main therapeutic tools include: Mindfulness exercises, training attention to the present moment, non-judgmental observation of thoughts and emotions. Session content: Session 1: Introduction to the therapy, explaining objectives, and pre-test administration. Session 2: Teaching the basics of mindfulness and attention to present moment experience. Session 3: Identifying automatic thoughts and dysfunctional thought patterns. Session 4: Practicing non-judgmental observation and acceptance of thoughts and emotions. Session 5: Teaching body awareness and practicing breathing and relaxation. Session 6: Working on emotional regulation and coping with rumination. Session 7: Practical mindfulness exercises in everyday situations. Session 8: Session summary, reviewing exercises, post-test administration, and determining follow-up.
Category
Treatment - Other
2
Description
Control group: The control group will not receive any intervention during the research, but will receive the treatment intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.