A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol

Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Samaan, Zainab [verfasserIn] Litke, Kathryn McCabe, Kathleen Dennis, Brittany Whattam, Jeff Garrick, Laura O’Neill, Laura Tabak, Terri Ann Simons, Scott Chalmers, Sandra Key, Brenda Vanstone, Meredith Xie, Feng Guyatt, Gordon Thabane, Lehana

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2015

Schlagwörter:	Pragmatic Pilot Protocol Trial Randomized Behavioural Activation Group Depression Adult

Anmerkung:	© Samaan et al. 2015

Übergeordnetes Werk:	Enthalten in: Pilot and feasibility studies - London : BioMed Central, 2015, 1(2015), 1 vom: 10. Nov.
Übergeordnetes Werk:	volume:1 ; year:2015 ; number:1 ; day:10 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s40814-015-0034-y

Katalog-ID:	SPR037848046

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allfields	10.1186/s40814-015-0034-y doi (DE-627)SPR037848046 (SPR)s40814-015-0034-y-e DE-627 ger DE-627 rakwb eng Samaan, Zainab verfasserin aut A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Samaan et al. 2015 Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213 Litke, Kathryn aut McCabe, Kathleen aut Dennis, Brittany aut Whattam, Jeff aut Garrick, Laura aut O’Neill, Laura aut Tabak, Terri Ann aut Simons, Scott aut Chalmers, Sandra aut Key, Brenda aut Vanstone, Meredith aut Xie, Feng aut Guyatt, Gordon aut Thabane, Lehana aut Enthalten in Pilot and feasibility studies London : BioMed Central, 2015 1(2015), 1 vom: 10. Nov. (DE-627)818042532 (DE-600)2809935-7 2055-5784 nnns volume:1 year:2015 number:1 day:10 month:11 https://dx.doi.org/10.1186/s40814-015-0034-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2015 1 10 11
spelling	10.1186/s40814-015-0034-y doi (DE-627)SPR037848046 (SPR)s40814-015-0034-y-e DE-627 ger DE-627 rakwb eng Samaan, Zainab verfasserin aut A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Samaan et al. 2015 Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213 Litke, Kathryn aut McCabe, Kathleen aut Dennis, Brittany aut Whattam, Jeff aut Garrick, Laura aut O’Neill, Laura aut Tabak, Terri Ann aut Simons, Scott aut Chalmers, Sandra aut Key, Brenda aut Vanstone, Meredith aut Xie, Feng aut Guyatt, Gordon aut Thabane, Lehana aut Enthalten in Pilot and feasibility studies London : BioMed Central, 2015 1(2015), 1 vom: 10. Nov. (DE-627)818042532 (DE-600)2809935-7 2055-5784 nnns volume:1 year:2015 number:1 day:10 month:11 https://dx.doi.org/10.1186/s40814-015-0034-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2015 1 10 11
allfields_unstemmed	10.1186/s40814-015-0034-y doi (DE-627)SPR037848046 (SPR)s40814-015-0034-y-e DE-627 ger DE-627 rakwb eng Samaan, Zainab verfasserin aut A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Samaan et al. 2015 Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213 Litke, Kathryn aut McCabe, Kathleen aut Dennis, Brittany aut Whattam, Jeff aut Garrick, Laura aut O’Neill, Laura aut Tabak, Terri Ann aut Simons, Scott aut Chalmers, Sandra aut Key, Brenda aut Vanstone, Meredith aut Xie, Feng aut Guyatt, Gordon aut Thabane, Lehana aut Enthalten in Pilot and feasibility studies London : BioMed Central, 2015 1(2015), 1 vom: 10. Nov. (DE-627)818042532 (DE-600)2809935-7 2055-5784 nnns volume:1 year:2015 number:1 day:10 month:11 https://dx.doi.org/10.1186/s40814-015-0034-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2015 1 10 11
allfieldsGer	10.1186/s40814-015-0034-y doi (DE-627)SPR037848046 (SPR)s40814-015-0034-y-e DE-627 ger DE-627 rakwb eng Samaan, Zainab verfasserin aut A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Samaan et al. 2015 Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213 Litke, Kathryn aut McCabe, Kathleen aut Dennis, Brittany aut Whattam, Jeff aut Garrick, Laura aut O’Neill, Laura aut Tabak, Terri Ann aut Simons, Scott aut Chalmers, Sandra aut Key, Brenda aut Vanstone, Meredith aut Xie, Feng aut Guyatt, Gordon aut Thabane, Lehana aut Enthalten in Pilot and feasibility studies London : BioMed Central, 2015 1(2015), 1 vom: 10. Nov. (DE-627)818042532 (DE-600)2809935-7 2055-5784 nnns volume:1 year:2015 number:1 day:10 month:11 https://dx.doi.org/10.1186/s40814-015-0034-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2015 1 10 11
allfieldsSound	10.1186/s40814-015-0034-y doi (DE-627)SPR037848046 (SPR)s40814-015-0034-y-e DE-627 ger DE-627 rakwb eng Samaan, Zainab verfasserin aut A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Samaan et al. 2015 Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213 Litke, Kathryn aut McCabe, Kathleen aut Dennis, Brittany aut Whattam, Jeff aut Garrick, Laura aut O’Neill, Laura aut Tabak, Terri Ann aut Simons, Scott aut Chalmers, Sandra aut Key, Brenda aut Vanstone, Meredith aut Xie, Feng aut Guyatt, Gordon aut Thabane, Lehana aut Enthalten in Pilot and feasibility studies London : BioMed Central, 2015 1(2015), 1 vom: 10. Nov. (DE-627)818042532 (DE-600)2809935-7 2055-5784 nnns volume:1 year:2015 number:1 day:10 month:11 https://dx.doi.org/10.1186/s40814-015-0034-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2015 1 10 11
language	English
source	Enthalten in Pilot and feasibility studies 1(2015), 1 vom: 10. Nov. volume:1 year:2015 number:1 day:10 month:11
sourceStr	Enthalten in Pilot and feasibility studies 1(2015), 1 vom: 10. Nov. volume:1 year:2015 number:1 day:10 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Pragmatic Pilot Protocol Trial Randomized Behavioural Activation Group Depression Adult
isfreeaccess_bool	true
container_title	Pilot and feasibility studies
authorswithroles_txt_mv	Samaan, Zainab @@aut@@ Litke, Kathryn @@aut@@ McCabe, Kathleen @@aut@@ Dennis, Brittany @@aut@@ Whattam, Jeff @@aut@@ Garrick, Laura @@aut@@ O’Neill, Laura @@aut@@ Tabak, Terri Ann @@aut@@ Simons, Scott @@aut@@ Chalmers, Sandra @@aut@@ Key, Brenda @@aut@@ Vanstone, Meredith @@aut@@ Xie, Feng @@aut@@ Guyatt, Gordon @@aut@@ Thabane, Lehana @@aut@@
publishDateDaySort_date	2015-11-10T00:00:00Z
hierarchy_top_id	818042532
id	SPR037848046
language_de	englisch
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author	Samaan, Zainab
spellingShingle	Samaan, Zainab misc Pragmatic misc Pilot misc Protocol misc Trial misc Randomized misc Behavioural misc Activation misc Group misc Depression misc Adult A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol
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topic_title	A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol Pragmatic (dpeaa)DE-He213 Pilot (dpeaa)DE-He213 Protocol (dpeaa)DE-He213 Trial (dpeaa)DE-He213 Randomized (dpeaa)DE-He213 Behavioural (dpeaa)DE-He213 Activation (dpeaa)DE-He213 Group (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Adult (dpeaa)DE-He213
topic	misc Pragmatic misc Pilot misc Protocol misc Trial misc Randomized misc Behavioural misc Activation misc Group misc Depression misc Adult
topic_unstemmed	misc Pragmatic misc Pilot misc Protocol misc Trial misc Randomized misc Behavioural misc Activation misc Group misc Depression misc Adult
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title	A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol
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title_full	A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol
author_sort	Samaan, Zainab
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author_browse	Samaan, Zainab Litke, Kathryn McCabe, Kathleen Dennis, Brittany Whattam, Jeff Garrick, Laura O’Neill, Laura Tabak, Terri Ann Simons, Scott Chalmers, Sandra Key, Brenda Vanstone, Meredith Xie, Feng Guyatt, Gordon Thabane, Lehana
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title_sort	pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the brave pilot trial protocol
title_auth	A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol
abstract	Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. © Samaan et al. 2015
abstractGer	Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. © Samaan et al. 2015
abstract_unstemmed	Background Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Methods/Design Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. Discussion The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Trial registration Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14–042. © Samaan et al. 2015
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title_short	A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol
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A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol

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