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BACKGROUND:Mindfulness interventions to reduce psychological distress are well-suited to pregnancy, due to their brief and non-pharmacological nature, but there is a need for more robust evidence determining their usefulness. This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression, anxiety and stress.
METHODS:
The study was designed in two parts 1) a non-randomised trial targeting women at risk of mental health problems (a selected population) and 2) a randomised controlled trial (RCT) of a universal population. Process evaluation focused on feasibility of recruitment pathways, participant retention, acceptability of study measures, and engagement with mindfulness practices. Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised, the Depression Anxiety and Stress Scale-21, the State-Trait Anxiety Inventory, and the Perceived Stress Scale.
RESULTS:
20 women were recruited to the non-randomised trial, and 32 to the RCT. Recruitment through a mailed study brochure at the time of booking-in to the hospital resulted in the largest number of participants in the RCT (16/32; 50%), and resulted in considerably earlier recruitment (50% in first trimester, 50% second trimester) compared to recruitment through the antenatal clinic waiting room (86% in second trimester, 14% third trimester). Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety, indicating a sample with more symptomology than the general population. The most common reason for loss to follow-up was delivery of baby prior to follow-up (n = 9). In the non-randomised study, significant within group improvements to depression and anxiety were observed. In the intervention arm of the RCT there were significant within group improvements to anxiety and mindfulness. No between group differences for the intervention and 'care as usual' control group were observed.
CONCLUSIONS:
This small pilot study provides evidence on the feasibility of an antenatal mindfulness intervention to reduce psychological distress. Major challenges include: finding ways to facilitate recruitment in early pregnancy and engaging younger women and other vulnerable populations.
BackgroundDepression is a common condition that typically has a relapsing course. Effective interventions targeting relapse have the potential to dramatically reduce the point prevalence of the condition. Mindfulness-based cognitive therapy (MBCT) is a group-based intervention that has shown efficacy in reducing depressive relapse. While trials of MBCT to date have met the core requirements of phase 1 translational research, there is a need now to move to phase 2 translational research - the application of MBCT within real-world settings with a view to informing policy and clinical practice. The aim of this trial is to examine the clinical impact and health economics of MBCT under real-world conditions and where efforts have been made to assess for and prevent resentful demoralization among the control group. Secondary aims of the project involve extending the phase 1 agenda to an examination of the effects of co-morbidity and mechanisms of action.
Methods/Design
This study is designed as a prospective, multi-site, single-blind, randomised controlled trial using a group comparison design between involving the intervention, MBCT, and a self-monitoring comparison condition, Depression Relapse Active Monitoring (DRAM). Follow-up is over 2 years. The design of the study indicates recruitment from primary and secondary care of 204 participants who have a history of 3 or more episodes of Major Depression but who are currently well. Measures assessing depressive relapse/recurrence, time to first clinical intervention, treatment expectancy and a range of secondary outcomes and process variables are included. A health economics evaluation will be undertaken to assess the incremental cost of MBCT.
Discussion
The results of this trial, including an examination of clinical, functional and health economic outcomes, will be used to assess the role that this treatment approach may have in recommendations for treatment of depression in Australia and elsewhere. If the findings are positive, we expect that this research will consolidate the evidence base to guide the decision to fund MBCT and to seek to promote its availability to those who have experienced at least 3 episodes of depression.
BackgroundDepression is a common condition that typically has a relapsing course. Effective interventions targeting relapse have the potential to dramatically reduce the point prevalence of the condition. Mindfulness-based cognitive therapy (MBCT) is a group-based intervention that has shown efficacy in reducing depressive relapse. While trials of MBCT to date have met the core requirements of phase 1 translational research, there is a need now to move to phase 2 translational research - the application of MBCT within real-world settings with a view to informing policy and clinical practice. The aim of this trial is to examine the clinical impact and health economics of MBCT under real-world conditions and where efforts have been made to assess for and prevent resentful demoralization among the control group. Secondary aims of the project involve extending the phase 1 agenda to an examination of the effects of co-morbidity and mechanisms of action.
Methods/Design
This study is designed as a prospective, multi-site, single-blind, randomised controlled trial using a group comparison design between involving the intervention, MBCT, and a self-monitoring comparison condition, Depression Relapse Active Monitoring (DRAM). Follow-up is over 2 years. The design of the study indicates recruitment from primary and secondary care of 204 participants who have a history of 3 or more episodes of Major Depression but who are currently well. Measures assessing depressive relapse/recurrence, time to first clinical intervention, treatment expectancy and a range of secondary outcomes and process variables are included. A health economics evaluation will be undertaken to assess the incremental cost of MBCT.
Discussion
The results of this trial, including an examination of clinical, functional and health economic outcomes, will be used to assess the role that this treatment approach may have in recommendations for treatment of depression in Australia and elsewhere. If the findings are positive, we expect that this research will consolidate the evidence base to guide the decision to fund MBCT and to seek to promote its availability to those who have experienced at least 3 episodes of depression.
Professors at Harvard University transfer course material from 'Psychology and Social Relations 2750: Methods of Applied Social Research' to a published handbook to provide a tool for those conducting applied research. The authors address issues with research design and validity; discuss the precision of the estimate of effects; highlight the importance of careful analyses of the placement of participants; introduce the assumptions in data analyses; and discuss a variety of complicating issues that investigators can face.
Objective:While mindfulness-based cognitive therapy (MBCT) has demonstrated efficacy in reducing depressive relapse/recurrence over 12–18 months, questions remain around effectiveness, longer-term outcomes, and suitability in combination with medication. The aim of this study was to investigate within a pragmatic study design the effectiveness of MBCT on depressive relapse/recurrence over 2 years of follow-up.
Method:
This was a prospective, multi-site, single-blind trial based in Melbourne and the regional city of Geelong, Australia. Non-depressed adults with a history of three or more episodes of depression were randomised to MBCT + depression relapse active monitoring (DRAM) (n=101) or control (DRAM alone) (n=102). Randomisation was stratified by medication (prescribed antidepressants and/or mood stabilisers: yes/no), site of usual care (primary or specialist), diagnosis (bipolar disorder: yes/no) and sex. Relapse/recurrence of major depression was assessed over 2 years using the Composite International Diagnostic Interview 2.1.
Results:
The average number of days with major depression was 65 for MBCT participants and 112 for controls, significant with repeated-measures ANOVA (F(1, 164)=4.56, p=0.03). Proportionally fewer MBCT participants relapsed in both year 1 and year 2 compared to controls (odds ratio 0.45, p<0.05). Kaplan-Meier survival analysis for time to first depressive episode was non-significant, although trends favouring the MBCT group were suggested. Subgroup analyses supported the effectiveness of MBCT for people receiving usual care in a specialist setting and for people taking antidepressant/mood stabiliser medication.
Conclusions:
This work in a pragmatic design with an active control condition supports the effectiveness of MBCT in something closer to implementation in routine practice than has been studied hitherto. As expected in this translational research design, observed effects were less strong than in some previous efficacy studies but appreciable and significant differences in outcome were detected. MBCT is most clearly demonstrated as effective for people receiving specialist care and seems to work well combined with antidepressants.
Objective:While mindfulness-based cognitive therapy (MBCT) has demonstrated efficacy in reducing depressive relapse/recurrence over 12–18 months, questions remain around effectiveness, longer-term outcomes, and suitability in combination with medication. The aim of this study was to investigate within a pragmatic study design the effectiveness of MBCT on depressive relapse/recurrence over 2 years of follow-up.
Method:
This was a prospective, multi-site, single-blind trial based in Melbourne and the regional city of Geelong, Australia. Non-depressed adults with a history of three or more episodes of depression were randomised to MBCT + depression relapse active monitoring (DRAM) (n=101) or control (DRAM alone) (n=102). Randomisation was stratified by medication (prescribed antidepressants and/or mood stabilisers: yes/no), site of usual care (primary or specialist), diagnosis (bipolar disorder: yes/no) and sex. Relapse/recurrence of major depression was assessed over 2 years using the Composite International Diagnostic Interview 2.1.
Results:
The average number of days with major depression was 65 for MBCT participants and 112 for controls, significant with repeated-measures ANOVA (F(1, 164)=4.56, p=0.03). Proportionally fewer MBCT participants relapsed in both year 1 and year 2 compared to controls (odds ratio 0.45, p<0.05). Kaplan-Meier survival analysis for time to first depressive episode was non-significant, although trends favouring the MBCT group were suggested. Subgroup analyses supported the effectiveness of MBCT for people receiving usual care in a specialist setting and for people taking antidepressant/mood stabiliser medication.
Conclusions:
This work in a pragmatic design with an active control condition supports the effectiveness of MBCT in something closer to implementation in routine practice than has been studied hitherto. As expected in this translational research design, observed effects were less strong than in some previous efficacy studies but appreciable and significant differences in outcome were detected. MBCT is most clearly demonstrated as effective for people receiving specialist care and seems to work well combined with antidepressants.