Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03425487
• Date of registration: 01/02/2018
• Prospective Registration: Yes
• Primary sponsor: Hospital Miguel Servet
• Public title: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services
• Scientific title: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial
• Date of first enrolment: January 1, 2019
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03425487
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: 18-75 years old.

- Depressive and/or anxious disorder, or adjustment disorder with depressive or/and
anxious symptomatology, according to clinical criteria based on Diagnostic and
Statistical Manual of Mental Disorders (DSM-5).

- Disorder of mild or moderate severity according to clinical criteria (based on DSM-5).

- Understand perfectly spoken and written Spanish.

- Grant a written informed consent form

Exclusion Criteria:

- To have done any type of meditative/contemplative practice during the previous year.

- Any diagnose of disease that may affect central nervous system (brain pathology,
traumatic brain injury, dementia, etc.).

- Other psychiatric diagnoses or acute psychiatric illness (substance dependence or
abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.).

- Any medical, infectious or degenerative disease that may affect mood.

- Presence of delusional ideas or hallucinations consistent or not with mood, and
suicide risk.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxious-Depressive

Intervention(s)

Behavioral: Compassion based Intervention

Behavioral: Mindfulness based Intervention

Other: TAU

Primary Outcome(s)

Depression Anxiety Stress Scales [Time Frame: Baseline]

Depression Anxiety Stress Scales [Time Frame: Post-treatment 8 weeks from baseline in TAU control group]

Depression Anxiety Stress Scales [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group]

Depression Anxiety Stress Scales [Time Frame: Six-months follow-up]

Depression Anxiety Stress Scales [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group]

Secondary Outcome(s)

Client Service Receipt Inventory (CSRI) [Time Frame: Baseline]

Five Facet Mindfulness Questionnaire [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group]

Five Facet Mindfulness Questionnaire [Time Frame: Six-months follow-up]

Self-Compassion Scale [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group]

Five Facet Mindfulness Questionnaire [Time Frame: Baseline]

Five Facet Mindfulness Questionnaire [Time Frame: Post-treatment 8 weeks from baseline in TAU control group]

Five Facet Mindfulness Questionnaire [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group]

Self-Compassion Scale [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group]

Self-Compassion Scale [Time Frame: Six-months follow-up]

EuroQol-5D. Health related quality of life [Time Frame: Baseline]

EuroQol-5D. Health related quality of life [Time Frame: Post-treatment 8 weeks from baseline in TAU control group]

Sociodemographic data such as gender, age, marital status, education, occupation, economical level [Time Frame: Baseline]

EuroQol-5D. Health related quality of life [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group]

Client Service Receipt Inventory (CSRI) [Time Frame: Six-months follow-up]

EuroQol-5D. Health related quality of life [Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group]

Self-Compassion Scale [Time Frame: Baseline]

Self-Compassion Scale [Time Frame: Post-treatment 8 weeks from baseline in TAU control group]

EuroQol-5D. Health related quality of life [Time Frame: Six-months follow-up]

Secondary ID(s)

7/2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors