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| Name | Class |
|---|---|
| pH Associates | UNKNOWN |
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The impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease. Data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation. Given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians. This study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.
This was a multi-center, prospective, post-marketing observational study of participants with severe chronic plaque psoriasis who began adalimumab therapy in the United Kingdom. Although 153 participants enrolled in the study, data was only analyzed on 143 individuals and there were no interventions or changes to participant management for the study. Prior to initiating adalimumab therapy (baseline), the Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area Severity Index (SAPASI), Hospital Anxiety and Depression Scale (HADS), Cutaneous Body Image (CBI) scale, Short Form 12 (SF-12) Health Survey, Female Sexual Function Index (FSFI) (female participants) and International Index of Erectile Function (IIEF) (male participants) questionnaires were completed by participants and at 4 weeks, 16 weeks and 6 months following initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with severe psoriasis | The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Scores | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. "Responders" to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation. | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation. |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary Care Outpatients
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| Name | Affiliation | Role |
|---|---|---|
| Neil Pumford, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Severe Psoriasis | The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. Baseline demographic data was not available for all participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Severe Psoriasis | The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dermatology Life Quality Index (DLQI) Scores | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation. | Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
From informed consent to completion of final study questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Severe Psoriasis | The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation. | 4 weeks, 16 weeks, and 6 months after adalimumab initiation |
| Psoriasis Area and Severity Index (PASI) Scores | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation. | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Hospital Anxiety and Depression Scale (HADS) Scores | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation. | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Cutaneous Body Image Scale (CBI) Scores | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation. | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| 12-item Short Form Survey (SF-12) Score | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Change in 12-item Short Form Survey (SF-12) Score From Baseline | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation. | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| Female Sexual Function Index (FSFI) Score | The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation. | Baseline; 16 weeks, and 6 months following adalimumab initiation |
| Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation. | 4 week, 16 weeks, and 6 months following adalimumab initiation |
| International Index of Erectile Function Score | The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation. | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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|
| Primary | Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. "Responders" to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation. | Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
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| Secondary | Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation. | Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| Secondary | Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation. | Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months after adalimumab initiation |
|
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Scores | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation. | Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| Secondary | Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation. | Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Scores | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation. | Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| Secondary | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation. | Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
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| Secondary | Cutaneous Body Image Scale (CBI) Scores | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation. | Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
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| Secondary | Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation. | Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
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| Secondary | 12-item Short Form Survey (SF-12) Score | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation. | Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| Secondary | Change in 12-item Short Form Survey (SF-12) Score From Baseline | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation. | Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
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| Secondary | Female Sexual Function Index (FSFI) Score | The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation. | Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 16 weeks, and 6 months following adalimumab initiation |
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| Secondary | Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation. | Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 week, 16 weeks, and 6 months following adalimumab initiation |
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| Secondary | International Index of Erectile Function Score | The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation. | Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation |
|
|
|
| 0 |
| 143 |
| 5 |
| 143 |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Rash pustular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| 6 Months (n=97) |
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 6 Months (n=91) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| HADS-A 6 Months (n=100) |
|
| HADS-D Baseline |
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| HADS-D 4 Weeks (n=43) |
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| HADS-D 16 Weeks (n=80) |
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| HADS-D 6 Months (n=100) |
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| HADS-D 4 Weeks (n=36) |
|
| HADS-D 16 Weeks (n=74) |
|
| HADS-D 6 Months (n=93) |
|
| Title | Measurements |
|---|---|
|
| 6 Months (n=100) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| SF-12 Physical 6 Months (n=97) |
|
| SF-12 Mental Baseline |
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| SF-12 Mental 4 Weeks (n=42) |
|
| SF-12 Mental 16 Weeks (n=74) |
|
| SF-12 6 Months (n=97) |
|
|
| SF-12 Mental 4 Weeks (n=36) |
|
| SF-12 Mental 16 Weeks (n=69) |
|
| SF-12 Mental 6 Months (n=89) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 6 Months (n=47) |
|