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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

February 1, 2018
February 7, 2018
February 9, 2018
January 1, 2018
July 2018   (Final data collection date for primary outcome measure)
  • 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").
  • 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").
  • 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").
  • 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").
  • 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").
  • 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").
  • 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").
  • 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").
  • 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").
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Baseline ]
    In the TAU control group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU control group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Six-months follow-up ]
    In the TAU control group
Complete list of historical versions of study NCT03425487 on ClinicalTrials.gov Archive Site
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the TAU control group
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the TAU group control
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the TAU group control
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the TAU control group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline ]
    In the TAU control group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Six-months follow-up ]
    In the TAU group control
  • Self-Compassion Scale (SCS) [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Baseline ]
    In the TAU group control
  • Self-Compassion Scale (SCS) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group ]
    In the MBSR based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group ]
    In the ABCT based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control
  • Self-Compassion Scale (SCS) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • Self-Compassion Scale (SCS) [ Time Frame: Six-months follow-up ]
    In the TAU group control
  • EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • EuroQol-5D. Health related quality of life [ Time Frame: Baseline ]
    In the TAU group control
  • 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
  • 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
  • EuroQol-5D. Health related quality of life [ Time Frame: Post-treatment 8 weeks from baseline in TAU control group ]
    In the TAU group control
  • EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • EuroQol-5D. Health related quality of life [ Time Frame: Six-months follow-up ]
    In the TAU group control
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the MBSR based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the ABCT based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the TAU group control
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the MBSR based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the ABCT based intervention group
  • Client Service Receipt Inventory (CSRI) [ Time Frame: Six-months follow-up ]
    In the TAU group control
Not Provided
Not Provided
 
Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services
Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxious-Depressive
  • 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
  • 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.
  • Other: TAU
    Usual specialized treatment in mental health (psychological or/and psychiatric)
  • 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.
    Intervention: Behavioral: Mindfulness based Intervention
  • 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.
    Intervention: Behavioral: Compassion based Intervention
  • Active Comparator: TAU
    Usual specialized treatment in mental health (psychological or/and psychiatric)
    Intervention: Other: TAU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
January 2019
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Carlos D. Collado Navarro, Internal Resident Psychologi 964558756 cdcn89@gmail.com
Spain
 
 
NCT03425487
7/2017
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Javier Garcia Campayo, Hospital Miguel Servet
Hospital Miguel Servet
Not Provided
Not Provided
Hospital Miguel Servet
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP