Clinical Research Directory

Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems

Complex posttraumatic stress disorder (cPTSD) is characterized by chronic and pervasive disruptions in emotion regulation, identity, and relationships following prolonged or multiple exposures to trauma. It is frequently found in patients with addiction. Individuals with cPTSD have more severe addiction. In addition, the co-occurrence of these two disorders is often associated with certain transdiagnostic processes such as impulsivity. Indeed, PTSD is linked to a higher impulsivity score, which in turn promotes increased substance use. A second process also associated with trauma and addiction is hostile attribution bias. Thus, the trauma-addiction comorbidity generates multiple behavioral consequences (aggression, increased substance use, etc.) that impact patients' quality of life and represent an important treatment target. Many authors and clinicians have worked on creating treatment programs targeting both disorders, although group format treatment lacks empirical support. Indeed, even though the Seeking Safety program has been shown to be effective in reducing PTSD symptoms and substance use, there is currently no evidence to suggest its superiority. The ECCCLORE program is a new 6-month cognitive behavioral therapy protocol initially designed for patients with borderline personality disorder, in whom addictive and traumatic issues are common. It is shorter than the standard dialectical behavioral therapy (DBT) program, which focuses on emotional dysregulation, impulsivity, and the traumatic dimension and lasts at least 1 year. It also integrates techniques from other approaches such as Acceptance and Commitment Therapy (ACT), which promotes the acceptance of internal experiences and engagement in actions consistent with values. It notably contains tools for developing emotional, distress tolerance, and interpersonal skills that could adapt to the difficulties generated by trauma and addiction. The objective of this research is to test the feasibility and acceptability of a 12-week ECCCLORE program adapted for patients with addictive and traumatic problems. The study investigators hypothesize that the implementation of this program will demonstrate satisfactory feasibility and acceptability.

Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy

A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE). Research question and hypothesis Primary 1. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 post-treatment? Secondary: 2. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 at 6 and 12 months follow up? 3. Are there significant differences between bTF-CT and PE when delivered in routine clinical care in terms of depression, anxiety, insomnia, functionality, complex PTSD, other PTSD-measures and treatment satisfaction post-treatment and at 6 and 12 months follow up? The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.

Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, which has been linked to lower quality of life and increased distress. FCR can be addressed in cancer survivors with brief interventions. However, none of these interventions have been tested with parents of childhood cancer survivors. This is an urgent gap: the survival rates of childhood cancer have increased more rapidly than for adult cancers, resulting in a growing population of childhood cancer survivors who, along with their families, need support. The goals of this pilot study are to demonstrate 1) that a newly adapted intervention of FORT (Parent-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., parent satisfaction of the intervention) for a larger study, and 2) the clinical implications of Parent-FORT on fear of cancer recurrence (FCR) and quality of life in parents of childhood cancer survivors. Parents will be randomly assigned to participate in the Parent-FORT intervention immediately or a three-month waitlist control group. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. This study will help bridge an important gap in bringing evidence-based care to parents who have never been offered help before for their FCR.

Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity

This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED. The primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions. Adult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions. Changes in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.

SGM Evidenced-Based Mental Healthcare Implementation

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)- affirmative Cognitive-Behavioral Therapy (CBT) at LGBTQ community centers across the United States.

Pain and Weight Treatment: Development and Trial of PAW

Pediatric weight management efficacy is impacted by failure to complete treatment protocols and, for those that do complete treatment, a return to unhealthy behaviors. This project tests whether treating pain, a common comorbid condition to pediatric obesity, will enhance treatment. This study will generate results that can be translated into immediate improvements in care for families seeking treatment for pediatric obesity.

CBT and the Neural Circuits of Anxiety

This study will aim to test whether specific neural circuitry changes, proposed on the basis of a neurocognitive model of anxiety, are a mechanism of action for Cognitive Behavioural Therapy (CBT) interventions. This study aims to provide a theoretical model of the neurobiological mechanisms of CBT's therapeutic effect, where there currently is none, and potentially allow for more targeted/specific approaches to anxiety disorders following the identification of key CBT mechanisms. The ultimate aim is to improve the efficacy of CBT, and more generally, psychological interventions for anxiety disorders.

Brief Cognitive Behaviour Therapy (CBT) for Adolescent OCD in Routine Clinical Practice

Obsessive-Compulsive Disorder (OCD) is a common and often disabling condition in young people, characterised by distressing, intrusive thoughts, images or urges, and repetitive behaviours intended to reduce discomfort or prevent harm. Around 1% of adolescents in the UK experience OCD, with many cases beginning in childhood or adolescence. Cognitive Behavioural Therapy (CBT) is the recommended treatment for OCD in young people, but access to treatment is limited due to high demand, long waiting lists, and lack of trained clinicians. A brief form of CBT for OCD, supported by workbooks, has previously shown promising results in research settings. However, it remains unclear whether this approach is feasible, acceptable, and effective when delivered within routine NHS child and adolescent mental health services (CAMHS), especially for young people with co-occurring autism. This single-arm feasibility trial aims to explore whether brief CBT can be delivered effectively in routine NHS and NHS-commissioned services to young people aged 11-18 years with OCD as their main presenting problem. The trial will also assess whether the intervention is acceptable to young people, their parents/carers, and clinicians, and whether outcomes are comparable to existing evidence. Intervention Overview: The brief CBT intervention consists of five core sessions, with the option of two additional booster sessions, delivered over 24 weeks. Sessions are delivered face-to-face by trained clinicians and last between 60 to 90 minutes. The intervention is supported by a series of co-designed workbooks to be completed by the young person between sessions. Parents/carers are also provided with a workbook and encouraged to support the young person's progress where appropriate. Sessions may take place in the clinic or in other agreed settings, such as at home or school. The frequency of sessions decreases over time, with the first four sessions delivered weekly and later sessions spaced further apart. The intervention includes psychoeducation, developing a cognitive-behavioural understanding of OCD, goal setting, and techniques to support motivation and engagement. A key focus is helping young people develop cognitive flexibility by testing and challenging unhelpful beliefs that drive OCD behaviours, supported by behavioural experiments. Parents/carers and other adults in the young person's life may also be involved to help generalise learning and promote progress. Trial Aims: The trial has two primary aims: To establish whether brief CBT for OCD can be delivered with fidelity and acceptability by clinicians in NHS services, and is acceptable to young people and their families. To explore whether the intervention is associated with significant improvements in OCD symptoms for young people, including those with autism or high levels of autistic traits. Trial Design: The study is a single-arm feasibility trial. Between 20-30 young people aged 11-18 years will be recruited alongside their parents/carers. Approximately 8-10 clinicians will be trained to deliver the intervention. OCD symptoms, treatment processes, and acceptability will be assessed at baseline, post-treatment (12 weeks), and at 3-month follow-up (24 weeks). Additional measures will be collected before each therapy session. Qualitative interviews will be conducted with young people, parents/carers, and clinicians to understand their experiences of the intervention. Acceptability will also be measured using standardised questionnaires completed during and after treatment. Outcomes: The primary outcomes are feasibility and acceptability of the intervention, assessed through session attendance, participant engagement, clinician adherence, and feedback from young people, parents/carers, and clinicians. Secondary outcomes include changes in OCD symptoms, responsibility beliefs, family accommodation, and overall functioning, as well as measures of anxiety and depression. Data will be analysed to assess changes from baseline to post-treatment and follow-up, including for young people with and without autistic traits. Treatment adherence and clinician competence will also be evaluated.

Effects of CBT-Based Intervention Among Patients With Liver Cancer

This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.