Internet-based UP-A intervention on treatment of stress, anxiety, depression, and psychological flexibility among adolescents with sub-clinical diagnosis of emotional disorders during the COVID-19 pandemic: a clinical trial.

This clinical trial aims to assess the effectiveness of internet-based Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) during the COVID-19 pandemic in reducing stress, anxiety, and depression, and psychological flexibility. 40 adolescents with subclinical features of emotional disorder randomly divided into two groups of intervention and control. The participants first completed DASS-21 and AAQ-2 questionnare online. Then, the intervention group received 12 sessions of UP-A through video calls on WhatsApp, 2 days per week each for 45 min. UP-A is an emotion-focused, cognitive-behavioral therapy consisting of 5 core modules or components that target temperamental characteristics, particularly neuroticism and resulting emotion dysregulation. Eventually the stress, anxiety, and depression levels decreased in intervention group and their psychological flexibility increased immediately and 3 months after the intervention. Clinical trial registration This study was registered by Iranian Registry of Clinical Trials (Prospective, ID: IRCT20210428051113N1, Registration date: 14/06/2021; https://en.irct.ir/trial/55900 ).

Transdiagnostic therapy compared to progressive muscle relaxation on the emotional health of mothers with premature infants: A randomized controlled trial.

OBJECTIVE: The aim of this study was to compare the effects of transdiagnostic therapy compared to progressive muscle relaxation (PMR) on emotion regulation strategies, self-compassion, maternal role adaptation, and social and work adjustment in mothers of premature infants. MATERIALS AND METHODS: This was a randomized controlled trial with two groups and pre-test, post-test, and a two-month follow-up assessment. Included were 27 mothers randomly assigned to either the transdiagnostic therapy group or the PMR group (13 in the transdiagnostic group and 14 in the PMR group). The experimental group received eight sessions of transdiagnostic therapy while the control group received eight sessions of PMR. The participants completed the following scales: Emotion Regulation Questionnaire, Self-Compassion Scale, Maternal Role Adaptation Scale, and Work and Social Adjustment Scale. RESULTS: Transdiagnostic therapy was significantly more effective than PMR in improving emotion regulation strategies, self-compassion, maternal role adaptation, and social and work adjustment based on the between-group comparison conducted at post-test and follow-up (p < 0.01). CONCLUSION: Transdiagnostic therapy was shown to be effective in improving the emotional health of mothers with premature infants and was more effective than PMR techniques.

Testing a Screening, Brief Intervention, and Referral to Treatment Intervention Approach for Addressing Unhealthy Alcohol and Other Drug Use in Humanitarian Settings: Protocol of the Ukuundapwa Chapamo Randomised Controlled Trial.

Refugees and other displaced persons are exposed to many risk factors for unhealthy alcohol and other drug (AOD) use and concomitant mental health problems. Evidence-based services for AOD use and mental health comorbidities are rarely available in humanitarian settings. In high income countries, screening, brief intervention and referral to treatment (SBIRT) systems can provide appropriate care for AOD use but have rarely been used in low- and middle-income countries and to our knowledge never tested in a humanitarian setting. This paper describes the protocol for a randomised controlled trial to compare the effectiveness of an SBIRT system featuring the Common Elements Treatment Approach (CETA) to treatment as usual in reducing unhealthy AOD use and mental health comorbidities among refugees from the Democratic Republic of the Congo and host community members in an integrated settlement in northern Zambia. The trial is an individually randomised, single-blind, parallel design with outcomes assessed at 6-months (primary) and 12-months post-baseline. Participants are Congolese refugees and Zambians in the host community, 15 years of age or older with unhealthy alcohol use. Outcomes are: unhealthy alcohol use (primary), other drug use, depression, anxiety and traumatic stress. The trial will explore SBIRT acceptability, appropriateness, cost-effectiveness, feasibility, and reach.

Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial.

BACKGROUND: Clinical and quality of life outcomes in people living with human immunodeficiency virus (PLWH) are undermined by unhealthy alcohol use (UAU), which is highly prevalent in this population and is often complicated by mental health (MH) or other substance use (SU) comorbidity. In sub-Saharan Africa, evidence-based and implementable treatment options for people with HIV and UAU are needed. METHODS: We are conducting a hybrid clinical effectiveness-implementation trial at three public-sector HIV clinics in Lusaka, Zambia. Adults with HIV, who report UAU, and have suboptimal HIV clinical outcomes, will be randomized to one of three arms: an alcohol-focused brief intervention (BI), the BI with additional referral to a transdiagnostic cognitive behavioral therapy (Common Elements Treatment Approach [CETA]), or standard of care. The BI and CETA will be provided by HIV peer counselors, a common cadre of lay health worker in Zambia. Clinical outcomes will include HIV viral suppression, alcohol use, assessed by audio computer-assisted self-interview (ACASI) and direct alcohol biomarkers, Phophatidylethanol and Ethyl glucuronide, and comorbid MH and other SU. A range of implementation outcomes including cost effectiveness will also be analyzed. CONCLUSION: Hybrid and 3-arm trial design features facilitate the integrated evaluation of both brief, highly implementable, and more intensive, less implementable, treatment options for UAU among PLWH in sub-Saharan Africa. Use of ACASI and alcohol biomarkers will strengthen understanding of treatment effects.

The efficacy of transdiagnostic cognitive behavioral therapy on migraine headache: a pilot, feasibility study.

INTRODUCTION: Psychological interventions are shown to be effective in migraine, but not utilized routinely yet. We aimed to evaluate the efficacy of transdiagnostic cognitive behavioral therapy (TCBT) on people with migraine (PwM). METHOD: This study was conducted on 40 PwM aged 20-50 years. We randomly assigned participants to two groups of intervention, receiving 10 sessions of TCBT, and control, attending one session on relaxation and stress-management techniques. Days with headache, headache severity, migraine-related disability and effects on daily life, number of pain-relivers taken for headache, depression, and anxiety were assessed pre-intervention, post-intervention (three-month follow-up), and one-month after TCBT termination (four-month follow-up). RESULTS: Thirty-five participants suffering moderate to severe migraine completed the study (16 and 19 in TCBT and control groups, respectively). TCBT improved all measured items between study time-points (p < 0.05) in the intervention group, while such an improvement was not observed in the control group. Between group comparisons revealed superiority of TCBT group compared to the control group in most measured items at three- and four-month follow-ups (p < 0.05). CONCLUSION: Ten sessions of TCBT improved migraine severity, associated disability, anxiety, and depression in PwM, with persistent effects after one month of therapy termination. However, the generalizability of these findings is limited due to the placebo effect in the intervention arm, given the more time each participant has spent with the therapist. TCBT could be an affordable, practical, and feasible intervention to be utilized for PwM and larger studies with equal number of sham therapy sessions are needed to further explore this. TRIAL REGISTRATION NUMBER: The study protocol was registered in clinicaltrial.gov ( NCT03701477 ) prior to enrollment.

Cost-effectiveness and cost-utility evaluation of individual vs. group transdiagnostic psychological treatment for emotional disorders in primary care (PsicAP-Costs): a multicentre randomized controlled trial protocol.

BACKGROUND: Emotional disorders are common, and they have become more prevalent since the COVID-19 pandemic. Due to a high attendance burden at the specialized level, most emotional disorders in Spain are treated in primary care, where they are usually misdiagnosed and treated using psychotropic drugs. This contributes to perpetuate their illness and increase health care costs. Following the IAPT programme and the transdiagnostic approach, the PsicAP project developed a brief group transdiagnostic cognitive-behavioural therapy (tCBT) as a cost-effective alternative. However, it is not suitable for everyone; in some cases, one-on-one sessions may be more effective. The objective of the present study is to compare, in cost-benefit terms, group and individual tCBT with the treatment usually administered in Spanish primary care (TAU). METHODS: A randomized, controlled, multicentre, and single-blinded trial will be performed. Adults with mild to moderate emotional disorders will be recruited and placed in one of three arms: group tCBT, individual tCBT, or TAU. Medical data and outcomes regarding emotional symptoms, disability, quality of life, and emotion regulation biases will be collected at baseline, immediately after treatment, and 6 and 12 months later. The data will be used to calculate incremental cost-effectiveness and cost-utility ratios. DISCUSSION: This trial aims to contribute to clinical practice research. The involvement of psychologists in primary care and the implementation of a stepped-care model for mental disorders are recommended. Group therapy and a transdiagnostic approach may help optimize health system resources and unblock waiting lists so that people can spend less time experiencing mental health problems. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04847310; Protocols.io: bx2npqde. (April 19, 2021).

"Despite the Differences, We Were All the Same". Group Cohesion in Diagnosis-Specific and Transdiagnostic CBT Groups for Anxiety and Depression: A Qualitative Study.

Group cohesion refers to a sense of belonging, mutual support and identification with other group members. Group cohesion has been associated with better outcomes, lower drop-out rates, more interpersonal support and better participation in psychotherapy. Nevertheless, the role of group cohesion in CBT has not yet received much attention. The rationale for delivering CBT in groups is that patients can model themselves through each other due to their similarities in symptoms. However, there has recently been a shift towards transdiagnostic CBT protocols, in which patients with varied diagnoses participate in the same groups. This shift challenges the rationale of delivering CBT in groups, and it is therefore highly important to understand if and how group cohesion develops in mixed diagnoses CBT groups. The current study used a qualitative comparative framework to investigate the patients' experiences of group cohesion in diagnosis-specific versus transdiagnostic CBT groups. Twenty-three patients were interviewed with semi-structured interviews upon completion of the treatment. Participants had a primary diagnosis of MDD, panic disorder, agoraphobia or social anxiety disorder. A comparative thematic analysis was carried out. Three themes were found: the move from differences to similarities, the role of group cohesion in group CBT and factors helpful and hindering to group cohesion. Group cohesion developed across groups and was considered highly important in both diagnosis-specific and transdiagnostic CBT groups.

Two-year treatment effects of the common elements treatment approach (CETA) for reducing intimate partner violence and unhealthy alcohol use in Zambia.

BACKGROUND: Intimate partner violence (IPV) and unhealthy alcohol use are common yet often unaddressed public health problems in low- and middle-income countries. In a randomized trial, we found that the common elements treatment approach (CETA), a multi-problem, flexible, transdiagnostic intervention, was effective in reducing IPV and unhealthy alcohol use among couples in Zambia at a 12-month post-baseline assessment. In this follow-up study, we investigated whether treatment effects were sustained among CETA participants at 24-months post-baseline. METHODS: Participants were heterosexual couples in Zambia in which the woman reported IPV perpetrated by the male partner and in which the male had hazardous alcohol use. Couples were randomized to CETA or treatment as usual plus safety checks. Measures were the Severity of Violence Against Women Scale (SVAWS) and the Alcohol Use Disorders Identification Test (AUDIT). The trial was stopped early upon recommendation by the trial's DSMB due to CETA's effectiveness following the 12-month assessment. Control participants exited the study and were offered CETA. This brief report presents data from an additional follow-up assessment conducted among original CETA participants at a 24-month visit. RESULTS: There were no meaningful changes in SVAWS or AUDIT scores between 12- and 24-months. The within-group treatment effect for SVAWS from baseline to 24-months was d = 1.37 (p < 0.0001) and AUDIT was d = 0.85 (p < 0.0001). CONCLUSIONS: The lack of change in levels of IPV and unhealthy alcohol use between the 12- and 24-month post-baseline timepoints suggests that treatment gains were sustained among participants who received CETA for at least two years from intervention commencement.

Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.

AIMS: Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia. METHODS: The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use. CONCLUSIONS: The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.

Australian Indigenous model of mental healthcare based on transdiagnostic cognitive-behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial.

BACKGROUND: A four- to seven-fold increase in the prevalence of current mood, anxiety, substance use and any mental disorders in Indigenous adults compared with non-Indigenous Australians has been reported. A lifetime prevalence of major depressive disorder was 23.9%. High rates of comorbid mental disorders indicated a transdiagnostic approach to treatment might be most appropriate. The effectiveness of psychological treatment for Indigenous Australians and adjunct Indigenous spiritual and cultural healing has not previously been evaluated in controlled clinical trials. AIMS: This project aims to develop, deliver and evaluate the effectiveness of an Indigenous model of mental healthcare (IMMHC). Trial registration: ANZCTR Registration Number: ACTRN12618001746224 and World Health Organization Universal Trial Number: U1111-1222-5849. METHOD: The IMMHC will be based on transdiagnostic cognitive-behaviour therapy co-designed with the Indigenous community to ensure it is socially and culturally appropriate for Indigenous Australians. The IMMHC will be evaluated in a randomised controlled trial with 110 Indigenous adults diagnosed with a current diagnosis of depression. The primary outcome will be the severity of depression symptoms as determined by changes in Beck Depression Inventory-II score at 6 months post-intervention. Secondary outcomes include anxiety, substance use disorder and quality of life. Outcomes will be assessed at baseline, 6 months post-intervention and 12 months post-intervention. RESULTS: The study design adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations and CONSORT extensions for pilot trials. We followed the Standard Protocol Items for Randomised Trials statement recommendations in writing the trial protocol. CONCLUSIONS: This study will likely benefit participants, as well as collaborating Aboriginal Medical Services and health organisations. The transdiagnostic IMMHC has the potential to have a substantial impact on health services delivery in the Indigenous health sector.

Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting (PsicAP Study): Protocol for a Randomized Controlled Trial.

BACKGROUND: Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate. OBJECTIVE: We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction. METHODS: Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain. RESULTS: This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018. CONCLUSIONS: We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries. CLINICALTRIAL: International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).

Intolerance of uncertainty and transdiagnostic group cognitive behavioral therapy for anxiety.

BACKGROUND: Recent evidence suggests intolerance of uncertainty (IU) is a transdiagnostic variable elevated across anxiety disorders. No studies have investigated IU's response to transdiagnostic group CBT for anxiety (TGCBT). This study evaluated IU outcomes following TGCBT across anxiety disorders. METHODS: 151 treatment-seekers with primary diagnoses of social anxiety disorder, panic disorder, or GAD were evaluated before and after 12 weeks of TGCBT and completed self-report questionnaires at pre-, mid-, and post-treatment. RESULTS: IU decreased significantly following treatment. Decreases in IU predicted improvements in clinical presentation across diagnoses. IU interacted with time to predict improvement in clinical presentation irrespective of primary diagnosis. IU also interacted with time to predict improvement in clinical presentation although interactions of time with diagnosis-specific measures did not. IUS interacted with time to predict reduction in anxiety and fear symptoms, and inhibitory IU interacted with time to predicted reductions in anxiety symptoms but prospective IU did not. CONCLUSION: IU appears to be an important transdiagnostic variable in CBT implicated in both initial presentation and treatment change. Further implications are discussed.

Transdiagnostic cognitive behavioural treatment and the impact of co-morbidity: An open trial in a cohort of primary care patients.

BACKGROUND: The development of initiatives to improve access to psychological therapies has been driven by the realization that untreated anxiety and depression are both very common and costly to individuals as well as society. Effective and efficient treatments, mostly in the form of cognitive behavioural therapies (CBT), can be used in ways which enhance their acceptability and accessibility. To date, numbers of group therapies have been developed to improve cost efficiency, but in spite of growing interest in transdiagnostic approaches, group therapies have so far mostly been diagnosis specific. AIMS: This study is aimed at evaluating a brief transdiagnostic cognitive behavioural group therapy (TCBGT) designed to treat both anxiety and depression among patients in primary care. METHOD: The participants were 287 adult patients in primary care with diagnoses of depression and/or anxiety disorders. They underwent a 5-week TCBGT. A mixed design ANOVA was used to evaluate differential effects of treatment according to diagnostic groups (anxiety versus depression) and number of diagnoses (co-morbidity). RESULTS: Pre-post differences were significant and the treatment was equally effective for both anxiety disorders and depression. Number of diagnoses did not affect the outcome. CONCLUSIONS: The study indicates feasibility of the brief transdiagnostic group therapy for a wide range of mood and anxiety disorders in primary care. The results indicate that low intensity, brief transdiagnostic group therapies may be a feasible way to improve access to psychological therapies for a large number of patients.