Anxious-Depressive Clinical Trial
Official title:
Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial
| NCT number | NCT03425487 |
| Other study ID # | 7/2017 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | October 31, 2019 |
| Verified date | February 2020 |
| Source | Hospital Miguel Servet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to assess and compare the benefits of twopsychological interventions
added to the usual treatment of patients whocome to mental health. Patients will be randomly
assigned to the followingconditions: Mindfulness-Based Stress Reduction (MBSR),
Attachment-BasedCompassion Therapy (ABCT) and a Treatment As Usual (TAU) Group.
Theparticipants in the two psychological intervention groups will also receive
usualpsychological/psychiatric treatment managed by their specialist. Mindfulnessand
Compassion groups will be composed of 33 participants each, and TAU group will be composed of
64 participants (total sample n = 130).
The principal hypothesis is that 'ABCT + TAU' will be more effective than'MBSR + TAU' for
treating depressive and/or anxiety symptoms in patients attending mental health settings.
Secondary hypothesis are: 1) 'MBSR + TAU'and 'ABCT + TAU' will be more effective than 'TAU
alone' for treatinganxiety and/or depressive symptoms in patients attending mental health
settings; 2) mindfulness will be a mediator of the 'MBSR + TAU' program improvements, while
self-compassion will be a mediator of the corresponding'ABCT + TAU'; and 3) 'ABCT + TAU' will
present more cost-effectiveness than 'MBSR + TAU' and both ABCT + TAU' and 'MBSR + TAU'
programs will present more cost-effectiveness than TAU alone.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | October 31, 2019 |
| Est. primary completion date | April 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario de la Plana | Castellón De La Plana |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Miguel Servet |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Baseline | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Baseline | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Baseline | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Post-treatment 8 weeks from baseline in TAU control group | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Six-months follow-up | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Six-months follow-up | |
| Primary | Depression Anxiety Stress Scales | 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). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126. | Six-months follow-up | |
| Secondary | Sociodemographic data such as gender, age, marital status, education, occupation, economical level | In the MBSR based intervention group | Baseline | |
| Secondary | Sociodemographic data such as gender, age, marital status, education, occupation, economical level | In the ABCT based intervention group | Baseline | |
| Secondary | Sociodemographic data such as gender, age, marital status, education, occupation, economical level | In the TAU control group | Baseline | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Baseline | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Baseline | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Baseline | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Post-treatment 8 weeks from baseline in TAU control group | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Six-months follow-up | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Six-months follow-up | |
| Secondary | Five Facet Mindfulness Questionnaire | 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. | Six-months follow-up | |
| Secondary | Self-Compassion Scale | 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. | Baseline | |
| Secondary | Self-Compassion Scale | 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. | Baseline | |
| Secondary | Self-Compassion Scale | 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. | Baseline | |
| Secondary | Self-Compassion Scale | 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. | Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group | |
| Secondary | Self-Compassion Scale | 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. | Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group | |
| Secondary | Self-Compassion Scale | 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. | Post-treatment 8 weeks from baseline in TAU control group | |
| Secondary | Self-Compassion Scale | 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. | Six-months follow-up | |
| Secondary | Self-Compassion Scale | 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. | Six-months follow-up | |
| Secondary | Self-Compassion Scale | 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. | Six-months follow-up | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Baseline | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Baseline | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Baseline | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Post-treatment 8 weeks from baseline in TAU control group | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Six-months follow-up | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Six-months follow-up | |
| Secondary | EuroQol-5D. Health related quality of life | 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. | Six-months follow-up | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the MBSR based intervention group | Baseline | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the ABCT based intervention group | Baseline | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the TAU group control | Baseline | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the MBSR based intervention group | Six-months follow-up | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the ABCT based intervention group | Six-months follow-up | |
| Secondary | Client Service Receipt Inventory (CSRI) | In the TAU group control | Six-months follow-up |