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Trial record 27 of 224 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03425487
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

Brief Summary:

The aim of this study is to assess and compare the benefits of two psychological interventions added to the usual treatment of patients who come to mental health. Patients will be randomly assigned to the following conditions: Mindfulness-Based Stress Reduction (MBSR), Attachment-Based Compassion Therapy (ABCT) and a Treatment As Usual (TAU) Group. The participants in the two psychological intervention groups will also receive usual psychological/psychiatric treatment managed by their specialist. Mindfulness and Compassion groups will be composed of 30 participants each, and TAU group will be composed of 60 participants (total sample n = 120).

The principal hypothesis is that Mindfulness- and Compassion-based therapy + TAU will be more effective than TAU alone for treating anxious and depressive symptoms in clinical population. Secondary hypothesis, are: 1) Clinical patients who participate in Mindfulness-based therapy will obtain more significant improvements in the psychological variables than patients who only perform TAU. 2) Clinical patients who participate in Compassion-based therapy will obtain more significant improvements in the psychological variables than patients who only perform TAU. 3) Mindfulness- and Compassion-based therapies will be more cost-effectiveness than TAU.


Condition or disease Intervention/treatment Phase
Anxious-Depressive Behavioral: Mindfulness based Intervention Behavioral: Compassion based Intervention Other: TAU Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBSR+TAU
Mindfulness based Intervention (MBSR) + Usual specialized treatment in mental health. MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.
Behavioral: Mindfulness based Intervention
MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months

Experimental: ABCT+TAU
Compassion based Intervention (ABCT) + Usual specialized treatment in mental health. ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.
Behavioral: Compassion based Intervention
ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.

Active Comparator: TAU
Usual specialized treatment in mental health (psychological or/and psychiatric)
Other: TAU
Usual specialized treatment in mental health (psychological or/and psychiatric)




Primary Outcome Measures :
  1. Depression Anxiety Stress Scales [ Time Frame: Baseline ]
    In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  2. Depression Anxiety Stress Scales [ Time Frame: Baseline ]
    In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  3. Depression Anxiety Stress Scales [ Time Frame: Baseline ]
    In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  4. Depression Anxiety Stress Scales [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  5. Depression Anxiety Stress Scales [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  6. Depression Anxiety Stress Scales [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  7. Depression Anxiety Stress Scales [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  8. Depression Anxiety Stress Scales [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").

  9. Depression Anxiety Stress Scales [ Time Frame: Six-months follow-up ]
    In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). Finally, in each of the subscales a low result is considered to be a "healthy" state ("depression": score range 0-9; "anxiety": 0-7; and "stress": 0-14 are interpreted as "normal").


Secondary Outcome Measures :
  1. Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the MBSR based intervention group

  2. Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the ABCT based intervention group

  3. Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the TAU control group

  4. Five Facet Mindfulness Questionnaire [ Time Frame: Baseline ]
    In the MBSR based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  5. Five Facet Mindfulness Questionnaire [ Time Frame: Baseline ]
    In the ABCT based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  6. Five Facet Mindfulness Questionnaire [ Time Frame: Baseline ]
    In the TAU control group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  7. Five Facet Mindfulness Questionnaire [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  8. Five Facet Mindfulness Questionnaire [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  9. Five Facet Mindfulness Questionnaire [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  10. Five Facet Mindfulness Questionnaire [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  11. Five Facet Mindfulness Questionnaire [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  12. Five Facet Mindfulness Questionnaire [ Time Frame: Six-months follow-up ]
    In the TAU group control. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.

  13. Self-Compassion Scale [ Time Frame: Baseline ]
    In the MBSR based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  14. Self-Compassion Scale [ Time Frame: Baseline ]
    In the ABCT based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  15. Self-Compassion Scale [ Time Frame: Baseline ]
    In the TAU group control. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  16. Self-Compassion Scale [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  17. Self-Compassion Scale [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  18. Self-Compassion Scale [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  19. Self-Compassion Scale [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  20. Self-Compassion Scale [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  21. Self-Compassion Scale [ Time Frame: Six-months follow-up ]
    In the TAU group control. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

  22. EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the MBSR based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  23. EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the ABCT based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  24. EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the TAU group control. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  25. EuroQol-5D. Health related quality of life [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  26. EuroQol-5D. Health related quality of life [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  27. EuroQol-5D. Health related quality of life [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  28. EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  29. EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  30. EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the TAU group control. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.

  31. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the MBSR based intervention group

  32. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the ABCT based intervention group

  33. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the TAU group control

  34. Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group

  35. Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group

  36. Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the TAU group control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-75 years old.
  • Anxious and / or depressive symptoms according to clinical criteria.
  • Disorder of mild or moderate severity according to clinical criteria.
  • Understand perfectly spoken and written Spanish.
  • Grant informed consent

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425487


Contacts
Contact: Carlos D. Collado Navarro, Internal Resident Psychologi 964558756 cdcn89@gmail.com

Locations
Spain
Hospital Universitario de la Plana Recruiting
Castellón De La Plana, Spain
Contact: Carlos D. Collado Navarro    964558756    cdcn89@gmail.com   
Sponsors and Collaborators
Hospital Miguel Servet

Responsible Party: Javier Garcia Campayo, Principal Investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT03425487     History of Changes
Other Study ID Numbers: 7/2017
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
Mindfulness
Compassion
Mental Health Services