Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial

Abstract Background Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to the hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT), and adrenocorticotropic hormone (ACTH). The object of this study is to evaluate the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopausal women with GAD. Methods This study is a single-center, randomized, single-blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for 4 weeks. The primary outcome measure will be the HAMA score. The secondary outcome measures will be the GAD-7 and PSQI scores and the levels of CORT and ACTH. The evaluation will be executed at baseline, 2 weeks, the end of the treatment, and a follow-up 3-month period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. Discussion This study intends to compare the efficacy between MA and PA in the treatment of perimenopausal women with GAD and to further study the mechanisms underlying the effect. Trial registration Chinese Clinical Trial Registry ChiCTR2100046604. Registered on 22 May 2021.

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Efficacy of Manual Acupuncture Versus Placebo Acupuncture for Generalized Anxiety Disorder (Gad) in Perimenopause Women : Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-577572/v1 ◽

2021 ◽

Author(s):

Xin Liu ◽

Xiaoyan Xie ◽

Yingjia Li ◽

Meichen Li ◽

Yuting Wang ◽

...

Keyword(s):

Clinical Trial ◽

Anxiety Disorder ◽

Behavioral Therapy ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Manual Acupuncture ◽

Clinical Trial Registry ◽

Double Blind ◽

Placebo Acupuncture

Abstract BackgroundGeneralized anxiety disorder (GAD) is common among perimenopause women. Drug treatment and cognitive behavioral therapy have their pros and cons. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT) and adrenocorticotropic hormone (ACTH). The object of this study is to assess the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopause women with GAD. MethodsThis study is a single center, randomized, double blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for four weeks. The primary outcome measure will be the score of GAD-7. The secondary outcome measures will be the score of HAMA and PSQI, and the level of CORT and ACTH. The evaluation will execute at baseline, 2 weeks, the end of the treatment and a follow-up period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. DiscussionThis study intends to conduct to compare the efficacy between MA and PA in the treatment of perimenopause woman with GAD, and to further study the mechanisms of effect. Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2100046604. Registered on 22 May 2021. URL: http://www.chictr.org.cn.

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Opipramol for the Treatment of Generalized Anxiety Disorder: A Placebo-Controlled Trial Including an Alprazolam-Treated Group

Journal of Clinical Psychopharmacology ◽

10.1097/00004714-200102000-00011 ◽

2001 ◽

Vol 21 (1) ◽

pp. 59-65 ◽

Cited By ~ 96

Author(s):

Hans-Jürgen Möller ◽

Hans-Peter Volz ◽

Ingrid W. Reimann ◽

Klaus-Dieter Stoll

Keyword(s):

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Controlled Trial ◽

Treated Group ◽

Generalized Anxiety

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Cognitive Behavior Therapy Targeting Intolerance of Uncertainty Versus Selective Serotonin Reuptake Inhibitor for Generalized Anxiety Disorder: A Randomized Clinical Trial

Behaviour Change ◽

10.1017/bec.2021.16 ◽

2021 ◽

pp. 1-13 ◽

Cited By ~ 1

Author(s):

Mehdi Zemestani ◽

Negar Beheshti ◽

Farzin Rezaei ◽

Colin van der Heiden ◽

Philip C. Kendall

Keyword(s):

Clinical Trial ◽

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Behavior Therapy ◽

Cognitive Behavior Therapy ◽

Serotonin Reuptake ◽

Intolerance Of Uncertainty ◽

Selective Serotonin ◽

Generalized Anxiety ◽

Cognitive Behavior

Abstract Given the high prevalence and adverse outcomes associated with generalized anxiety disorder (GAD), development and expansion of effective treatment modalities are important. The present study compared the effectiveness of cognitive behavior therapy targeting intolerance of uncertainty (CBT-IU) and selective serotonin reuptake inhibitors (SSRIs) for treating GAD. A total of 30 Iranian patients with GAD (Mage = 25.16 ± 6.73) were randomised to receive either CBT-IU (n = 15) or SSRI (n = 15). Measures included the Structured Clinical Interview for DSM-5 (SCID-5), Penn State Worry Questionnaire (PSWQ), Why Worry-II (WW-II), Intolerance of Uncertainty Scale (IUS), and Negative Problem Orientation Questionnaire (NPOQ). Repeated measures analysis of variance tested differential treatment outcomes. The results of intention-to-treat (ITT) analysis indicated that although both CBT-IU and SSRI were effective treatments for GAD, CBT-IU produced significantly better results than SSRI at post-treatment. This clinical trial provides preliminary cross-cultural support for the treatment of GAD using CBT-IU, with findings suggesting that this non-medication intervention reduces GAD symptoms.

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Clinical efficacy and psychological mechanisms of an app-based digital therapeutic for generalized anxiety disorder: a randomized controlled trial (Preprint)

10.2196/preprints.26987 ◽

2021 ◽

Author(s):

Alexandra Roy ◽

Elizabeth A. Hoge ◽

Pablo Abrante ◽

Susan Druker ◽

Tao Liu ◽

...

Keyword(s):

Reinforcement Learning ◽

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Clinical Efficacy ◽

Controlled Trial ◽

Population Level ◽

Generalized Anxiety ◽

Number Needed To Treat ◽

Treatment As Usual ◽

Psychological Mechanisms

BACKGROUND Current treatments for Generalized Anxiety Disorder (GAD) yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (e.g. avoidance reinforcement learning). Mindfulness training (MT), has shown efficacy for anxiety, yet widespread adoption has been limited, in part due to difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potential next-generation treatments, yet very few have been empirically validated. OBJECTIVE In this study, we tested the efficacy and mechanism of an app-delivered MT that was designed to target aberrant reinforcement learning. METHODS Individuals with GAD were randomized to receive Treatment as Usual (TAU, n=33) or TAU + app-delivered MT (n=28). Treatment-related changes in outcomes were assessed 1 and 2 months after treatment initiation. RESULTS In an intent-to-treat analysis, individuals in the MT group demonstrated a significant reduction in anxiety (GAD-7) relative to control (median (IQR) change in GAD-7: -8.5 (6.5) v. -1.0 (5.0), P<.001; 95% CI 6 to 10). Increases in mindfulness (non-reactivity subscale) mediated decreases in worry (PSWQ; P=.02), and decreases in worry mediated reductions in anxiety (P=.03). CONCLUSIONS This is the first report studying the efficacy and mechanism of app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT delivered as a digital therapeutic for individuals with anxiety (Number Needed to Treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways resulting in tangible, clinically-meaningful reductions in worry and anxiety. Evidence-based, mechanistically-targeted digital therapeutics have the potential to improve health on a population level at low cost. CLINICALTRIAL Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder (NCT03683472). URL - https://clinicaltrials.gov/ct2/show/NCT03683472?term=judson+brewer&draw=2&rank=1

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Therapist Behaviours in Internet-Delivered Cognitive Behaviour Therapy: Analyses of E-Mail Correspondence in the Treatment of Generalized Anxiety Disorder

Behavioural and Cognitive Psychotherapy ◽

10.1017/s1352465812000240 ◽

2012 ◽

Vol 41 (3) ◽

pp. 280-289 ◽

Cited By ~ 90

Author(s):

Björn Paxling ◽

Susanne Lundgren ◽

Anita Norman ◽

Jonas Almlöv ◽

Per Carlbring ◽

...

Keyword(s):

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Self Efficacy ◽

Cognitive Behaviour Therapy ◽

Psychological Treatment ◽

Controlled Trial ◽

Generalized Anxiety ◽

Behaviour Therapy ◽

Cognitive Behaviour ◽

State Worry

Background: Internet-delivered cognitive behaviour therapy (iCBT) has been found to be an effective way to disseminate psychological treatment, and support given by a therapist seems to be important in order to achieve good outcomes. Little is known about what the therapists actually do when they provide support in iCBT and whether their behaviour influences treatment outcome. Aims: This study addressed the content of therapist e-mails in guided iCBT for generalized anxiety disorder. Method: We examined 490 e-mails from three therapists providing support to 44 patients who participated in a controlled trial on iCBT for generalized anxiety disorder. Results: Through content analysis of the written correspondence, eight distinguishable therapist behaviours were derived: deadline flexibility, task reinforcement, alliance bolstering, task prompting, psychoeducation, self-disclosure, self-efficacy shaping, and empathetic utterances. We found that task reinforcement, task prompting, self-efficacy shaping and empathetic utterances correlated with module completion. Deadline flexibility was negatively associated with outcome and task reinforcement positively correlated with changes on the Penn State Worry Questionnaire. Conclusions: Different types of therapist behaviours can be identified in iCBT, and though many of these behaviours are correlated to each other, different behaviours have an impact on change in symptoms and module completion.

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