Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-03-20
Brief Title:
Exergames-acceptance and Commitment Therapy Program for Treatment of Major Depressive Disorder
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
The Efficacy of Exergames-acceptance and Commitment Therapy Program for Treatment of Major Depressive Disorder Comparison With Acceptance and Commitment Therapy Alone and Treatment-as-usual in a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The prevalence of depressive disorder particularly major depressive disorder is on the rise globally and the use of antidepressant medication for treatment does not usually resulting in full remission However combination of antidepressant medication and psychotherapy for treatment of major depressive disorder MDD increase the rate of full remission compared to antidepressant monotherapy This three-armed parallel-group double-blind randomized control trial RCT aims to assess and compare the effects of combination of exergame and acceptance and commitment e-ACT training programme and ACT only on psychiatric symptoms depression and anxiety experiential avoidance EA quality of life QoL and biomarkers of depression such as BDNF CRP and VEGF among MDD patients
Methods This RCT will recruit 120 patients diagnosed with MDD who will be randomized using stratified permuted block randomization into three groups which are combined e-ACT training programme ACT only and treatment-as-usual control groups in a 111 allocation ratio The participants in the e-ACT and ACT only intervention groups will undergo once a week intervention sessions for 8 weeks Assessments will be carried out through three time points such as the first assessment before intervention began t0 second assessment immediately after completion of intervention at 8 weeks t1 and third assessment 24 weeks after completion of intervention t2 During each assessment the primary outcome assessed is the severity of depression symptoms while the secondary outcomes assessed are severity of anxiety symptoms QoL EA and biomarkers of depression
Methods This RCT will recruit 120 patients diagnosed with MDD who will be randomized using stratified permuted block randomization into three groups which are combined e-ACT training programme ACT only and treatment-as-usual control groups in a 111 allocation ratio The participants in the e-ACT and ACT only intervention groups will undergo once a week intervention sessions for 8 weeks Assessments will be carried out through three time points such as the first assessment before intervention began t0 second assessment immediately after completion of intervention at 8 weeks t1 and third assessment 24 weeks after completion of intervention t2 During each assessment the primary outcome assessed is the severity of depression symptoms while the secondary outcomes assessed are severity of anxiety symptoms QoL EA and biomarkers of depression
Detailed Description:
Objective
General
To evaluate the efficacy of of exergames-acceptance and commitment therapy e-ACT training program compared to acceptance and commitment therapy ACT alone or a treatment-as-usual control group
Specific
Primary objectives
1To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing severity of depressive symptoms among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
Secondary objectives
1 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on increasing quality of life QoL among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
2 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing experiential avoidance EA among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
3 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing severity of anxiety symptoms among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
4 To assess the differences in biological markers such as BDNF CRP and VEGF among patients on exergames-acceptance and commitment therapy e-ACT training program ACT only and control group treatment-as-usual via blood biochemical analyses at 3 timelines pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
Research design
This randomized controlled trial RCT is multicentre three-armed parallel-group double-blind RCT
Study area
This RCT is expected to run for a duration of 3 years to be conducted in Psychiatric Outpatient clinic in Advanced Medical and Dental Institute Universiti Sains Malaysia AMDI USM and Psychiatric Outpatient clinic and Inpatient wards in Department of Psychiatry Hospital Universiti Sains Malaysia HUSM AMDI USM is a tertiary referral centre in which its psychiatry out-patient clinic has approximately 200 registered psychiatric patients in the northern region of Peninsular Malaysia While HUSM is a tertiary referral centre in which the Department of Psychiatry has approximately 500 to 700 registered psychiatric patients located in the northeast region of Peninsular Malaysia
Study population
This studys participants will be recruited from the source population This population includes all patients diagnosed with major depressive disorder and registered in AMDI USM and Department of Psychiatry HUSM
Sample size estimation
The sample size is determined based on G-Power 3192 for repeated measures between-within interaction ANOVA Based on the previous study the sample size was calculated based on a multicentre three-group parallel RCT which compared efficacy of physical exercise cognitive behavioral therapy and treatment-as-usual control group conducted by Hallgren et al 2018 with small effect size 013 an alpha error of 005 two-tailed The results indicated that the total sample of 90 for three equal-sized groups is needed to achieve a power of 095 In anticipation of a drop-out rate of 30 the estimation for sample size is 117 respondents and hence we round up to 120 subjects for the total respondents needed Therefore 40 respondents for each group
Sampling method and subject recruitment
The sampling method use in this study for recruitment of participants is by consecutive sampling
Recruitment of subjects
This studys participants will be recruited from the source population This population includes all patients diagnosed with major depressive disorder and registered in AMDI USM and Department of Psychiatry HUSM These patients will be approached by the research team and explained on the study objectives and procedures Those who are interested to participate in the study will be screened for inclusion and exclusion criteria
All eligible patients those with all inclusion criteria without any exclusion criteria will be invited to participate in this study The studys purposes and procedures will be thoroughly explained verbal explanation by the research assistant and a copy of the participant information will also be distributed to prospective participants before they are invited to participate in this study their anonymity will be assured and they will be informed of their right to withdraw from the study at any time and the data collected will be discarded Eligible patients will be given 48 hours to decide on their participation in the study Then participants will sign written informed consent to participate in the study before they enrol in the study
Intervention
An eight-week psychosocial intervention will be administered to participants in each intervention group e-ACT and ACT while participants in the control group will receive treatment-as-usual The studys outcomes will be assessed at three times pre-intervention t0 immediately after the eight-week intervention t1 and 24 weeks after the intervention t2 Both the e-ACT and ACT interventions will comprise eight sessions delivered at a rate of one session per week
1 exergames-acceptance and commitment therapy e-ACT training program In the e-ACT training program participants will perform a 30-minute per session Nintendo-program on TV for three days per week and a 50-minute ACT session per week for 8 weeks which will take place in the psychology labs of AMDI USM The ACT session will be held after 30 minutes break following the completion of the final exergame session of the week Hence the total duration of each weekly e-ACT training session will be approximately 2 hours In addition each weekly e-ACT training session will be held at the same time 2 hours and at the same venue
2 Acceptance and commitment therapy ACT
As for the ACT intervention each ACT session will run for 50 minutes one session per week for 8 weeks Each weekly ACT session will be held at the same time 2 hours and at the same venue in the psychology lab
3 Treatment-as-usual control TAU group
The participants in the control group will receive treatment-as-usual in which non-specific ingredients of the psychotherapeutic approach will be administered such as psychological understanding to the management of an individual patient identifying current problems providing opportunities for disclosure reassurance and deep breathing exercise They will be given equal amount of time and attention from the professional figure compared to the intervention groups whereby they will also attach to an 8-session program with one session per week for 8 weeks Each weekly TAU session will be held at the same time 2 hours and at the same venue in the psychology lab
Blinding
Participants will be kept unaware of the studys randomization into the designated groups conducted by a research assistant who is not otherwise involved in the study and concealed in an opaque sequentially numbered envelope Therefore participants will not know which group they are allocated to In addition the intervention groups e-ACT or ACT as well as the treatment-as-usual control group will receive an 8-session program with one session per week for 8 weeks and participants in the treatment-as-usual group will also receive equal amount of attention and time from the professional figure who administer the program
The researchers will also be blinded for the study since the participants randomized assignment into the designated groups will be conducted by a research assistant who is not otherwise involved in the study or data analysis This projects data collection will also be conducted by that research assistant who is not otherwise involved in the study or data analysis and who is unaware of the studys hypotheses Moreover the projects data analysis will be conducted by statisticians who are not otherwise involved in the study A statistical analysis plan is established prior to the final unblinded of the data lock
Data collection
Data collection will be conducted every weekday during working hours and flyers announcing the study and the benefits of participating in this study will be disseminated to all patients at the studys focal institutions in order to ensure adequate subject enrolment to achieve the calculated sample size This clinical trial protocol was written according to the Standard Protocol Items Recommendations for Intervention Trials 2013 Before the interventions began t0 the participants will be administered the socio-demographic and clinical characteristics questionnaire HAMD MADRS HAMA WHOQOL-BREF and AAQ-II Blood sample will also be collected from all participants to evaluate for the serum level of BDNF VEGF and CRP biomarkers for depression Then immediately after the end of the interventions at 8 weeks t1 assessments with HAMD MADRS HAMA WHOQOL-BREF and AAQ-II is repeated for all participants and blood sample collected for biomarker analysis Finally 24 weeks after the completion of the interventions t2 the questionnaire assessment is repeated for all participants and blood sample collected for biomarker analysis
General
To evaluate the efficacy of of exergames-acceptance and commitment therapy e-ACT training program compared to acceptance and commitment therapy ACT alone or a treatment-as-usual control group
Specific
Primary objectives
1To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing severity of depressive symptoms among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
Secondary objectives
1 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on increasing quality of life QoL among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
2 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing experiential avoidance EA among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
3 To evaluate the efficacy of exergames-acceptance and commitment therapy e-ACT training program on reducing severity of anxiety symptoms among patients with major depressive disorder compared to ACT only and a control group treatment-as-usual across three timelines such as pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
4 To assess the differences in biological markers such as BDNF CRP and VEGF among patients on exergames-acceptance and commitment therapy e-ACT training program ACT only and control group treatment-as-usual via blood biochemical analyses at 3 timelines pre-intervention immediately post-intervention 8 weeks and 24 weeks post-intervention
Research design
This randomized controlled trial RCT is multicentre three-armed parallel-group double-blind RCT
Study area
This RCT is expected to run for a duration of 3 years to be conducted in Psychiatric Outpatient clinic in Advanced Medical and Dental Institute Universiti Sains Malaysia AMDI USM and Psychiatric Outpatient clinic and Inpatient wards in Department of Psychiatry Hospital Universiti Sains Malaysia HUSM AMDI USM is a tertiary referral centre in which its psychiatry out-patient clinic has approximately 200 registered psychiatric patients in the northern region of Peninsular Malaysia While HUSM is a tertiary referral centre in which the Department of Psychiatry has approximately 500 to 700 registered psychiatric patients located in the northeast region of Peninsular Malaysia
Study population
This studys participants will be recruited from the source population This population includes all patients diagnosed with major depressive disorder and registered in AMDI USM and Department of Psychiatry HUSM
Sample size estimation
The sample size is determined based on G-Power 3192 for repeated measures between-within interaction ANOVA Based on the previous study the sample size was calculated based on a multicentre three-group parallel RCT which compared efficacy of physical exercise cognitive behavioral therapy and treatment-as-usual control group conducted by Hallgren et al 2018 with small effect size 013 an alpha error of 005 two-tailed The results indicated that the total sample of 90 for three equal-sized groups is needed to achieve a power of 095 In anticipation of a drop-out rate of 30 the estimation for sample size is 117 respondents and hence we round up to 120 subjects for the total respondents needed Therefore 40 respondents for each group
Sampling method and subject recruitment
The sampling method use in this study for recruitment of participants is by consecutive sampling
Recruitment of subjects
This studys participants will be recruited from the source population This population includes all patients diagnosed with major depressive disorder and registered in AMDI USM and Department of Psychiatry HUSM These patients will be approached by the research team and explained on the study objectives and procedures Those who are interested to participate in the study will be screened for inclusion and exclusion criteria
All eligible patients those with all inclusion criteria without any exclusion criteria will be invited to participate in this study The studys purposes and procedures will be thoroughly explained verbal explanation by the research assistant and a copy of the participant information will also be distributed to prospective participants before they are invited to participate in this study their anonymity will be assured and they will be informed of their right to withdraw from the study at any time and the data collected will be discarded Eligible patients will be given 48 hours to decide on their participation in the study Then participants will sign written informed consent to participate in the study before they enrol in the study
Intervention
An eight-week psychosocial intervention will be administered to participants in each intervention group e-ACT and ACT while participants in the control group will receive treatment-as-usual The studys outcomes will be assessed at three times pre-intervention t0 immediately after the eight-week intervention t1 and 24 weeks after the intervention t2 Both the e-ACT and ACT interventions will comprise eight sessions delivered at a rate of one session per week
1 exergames-acceptance and commitment therapy e-ACT training program In the e-ACT training program participants will perform a 30-minute per session Nintendo-program on TV for three days per week and a 50-minute ACT session per week for 8 weeks which will take place in the psychology labs of AMDI USM The ACT session will be held after 30 minutes break following the completion of the final exergame session of the week Hence the total duration of each weekly e-ACT training session will be approximately 2 hours In addition each weekly e-ACT training session will be held at the same time 2 hours and at the same venue
2 Acceptance and commitment therapy ACT
As for the ACT intervention each ACT session will run for 50 minutes one session per week for 8 weeks Each weekly ACT session will be held at the same time 2 hours and at the same venue in the psychology lab
3 Treatment-as-usual control TAU group
The participants in the control group will receive treatment-as-usual in which non-specific ingredients of the psychotherapeutic approach will be administered such as psychological understanding to the management of an individual patient identifying current problems providing opportunities for disclosure reassurance and deep breathing exercise They will be given equal amount of time and attention from the professional figure compared to the intervention groups whereby they will also attach to an 8-session program with one session per week for 8 weeks Each weekly TAU session will be held at the same time 2 hours and at the same venue in the psychology lab
Blinding
Participants will be kept unaware of the studys randomization into the designated groups conducted by a research assistant who is not otherwise involved in the study and concealed in an opaque sequentially numbered envelope Therefore participants will not know which group they are allocated to In addition the intervention groups e-ACT or ACT as well as the treatment-as-usual control group will receive an 8-session program with one session per week for 8 weeks and participants in the treatment-as-usual group will also receive equal amount of attention and time from the professional figure who administer the program
The researchers will also be blinded for the study since the participants randomized assignment into the designated groups will be conducted by a research assistant who is not otherwise involved in the study or data analysis This projects data collection will also be conducted by that research assistant who is not otherwise involved in the study or data analysis and who is unaware of the studys hypotheses Moreover the projects data analysis will be conducted by statisticians who are not otherwise involved in the study A statistical analysis plan is established prior to the final unblinded of the data lock
Data collection
Data collection will be conducted every weekday during working hours and flyers announcing the study and the benefits of participating in this study will be disseminated to all patients at the studys focal institutions in order to ensure adequate subject enrolment to achieve the calculated sample size This clinical trial protocol was written according to the Standard Protocol Items Recommendations for Intervention Trials 2013 Before the interventions began t0 the participants will be administered the socio-demographic and clinical characteristics questionnaire HAMD MADRS HAMA WHOQOL-BREF and AAQ-II Blood sample will also be collected from all participants to evaluate for the serum level of BDNF VEGF and CRP biomarkers for depression Then immediately after the end of the interventions at 8 weeks t1 assessments with HAMD MADRS HAMA WHOQOL-BREF and AAQ-II is repeated for all participants and blood sample collected for biomarker analysis Finally 24 weeks after the completion of the interventions t2 the questionnaire assessment is repeated for all participants and blood sample collected for biomarker analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None