Effects of group mindfulness-based cognitive therapy and group cognitive behavioural therapy on symptomatic generalized anxiety disorder: a randomized controlled noninferiority trial.
Study Goal
The researchers aimed to determine whether Mindfulness-Based Cognitive Therapy adapted for GAD (MBCT-A) was noninferior to Cognitive Behavioral Therapy adapted for GAD (CBT-A) in treating anxiety symptoms and other related outcomes.
Results Summary
MBCT-A was found to be noninferior to CBT-A in reducing anxiety symptoms, with no significant differences between the two groups at the 3-month follow-up. Both interventions showed long-term benefits, and no severe adverse events were reported.
Population
Adult patients with generalized anxiety disorder (GAD) (n=138).
Effective Dosage
Not specified
Duration
8 weeks of treatment, with follow-up assessments at 3 months.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | no change | anxiety response rate | symptomatic GAD patients | rate difference = 7.25% (95% CI: -8.16, 22.65) | was noninferior to | #1 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | no change | anxiety response rate | symptomatic GAD patients | rate difference = 5.85% (95% CI: -7.83, 19.53) | was noninferior to | #2 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | neutral | anxiety remission rate | symptomatic GAD patients | - | were significantly different | #3 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | neutral | overall illness severity | symptomatic GAD patients | - | were significantly different | #4 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | neutral | mindfulness | symptomatic GAD patients | - | were significantly different | #5 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | no change | anxiety symptoms | symptomatic GAD patients | - | were no significant differences | #6 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | no change | anxiety symptoms | GAD patients | - | was noninferior to | #7 |
Mindfulness-based cognitive therapy adapted for treating GAD (MBCT-A) | increase | long-term benefits | symptomatic GAD patients | - | appeared to be effective | #8 |
cognitive behavioural therapy designed to treat GAD (CBT-A) | increase | long-term benefits | symptomatic GAD patients | - | appeared to be effective | #9 |
BACKGROUND: Mindfulness-based cognitive therapy (MBCT) is a promising alternative treatment for generalized anxiety disorder (GAD). The objective of this study was to examine whether the efficacy of group MBCT adapted for treating GAD (MBCT-A) was noninferior to group cognitive behavioural therapy (CBT) designed to treat GAD (CBT-A), which was considered one of first-line treatments for GAD patients. We also explored the efficacy of MBCT-A in symptomatic GAD patients compared with CBT-A for a variety of outcomes of anxiety symptoms, as well as depressive symptoms, overall illness severity, quality of life and mindfulness. METHODS: This was a randomized, controlled, noninferiority trial with two arms involving symptomatic GAD patients. Adult patients with GAD (n = 138) were randomized to MBCT-A or CBT-A in addition to treatment as usual (TAU). The primary outcome was the anxiety response rate assessed at 8 weeks after treatment as measured using the Hamilton Anxiety Scale (HAMA). Secondary outcomes included anxiety remission rates, scores on the HAMA, the state-trait anxiety inventory (STAI), the Hamilton Depression Scale (HAMD), the Severity Subscale of the Clinical Global Impression Scale (CGI-S), and the 12-item Short-Form Health Survey (SF-12), as well as mindfulness, which was measured by the Five Facet Mindfulness Questionnaire (FFMQ). Assessments were performed at baseline, 8 weeks after treatment, and 3 months after treatment. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed for primary analyses. The χ2 test and separate two-way mixed ANOVAs were used for the secondary analyses. RESULTS: ITT and PP analyses showed noninferiority of MBCT-A compared with CBT-A for response rate [ITT rate difference = 7.25% (95% CI: -8.16, 22.65); PP rate difference = 5.85% (95% CI: - 7.83, 19.53)]. The anxiety remission rate, overall illness severity and mindfulness were significantly different between the two groups at 8 weeks. There were no significant differences between the two groups at the 3-month follow-up. No severe adverse events were identified. CONCLUSIONS: Our data indicate that MBCT-A was noninferior to CBT-A in reducing anxiety symptoms in GAD patients. Both interventions appeared to be effective for long-term benefits. TRIAL REGISTRATION: Registered at chictr.org.cn (registration number: ChiCTR1800019150 , registration date: 27/10/2018).