Cognitive Behavioral Therapy + Valuation for Depression and Anxiety
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Polytechnic Institute and State University
Disqualifiers: Seizure disorder, Stroke, Head injury, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This study examines how people respond to rewards and losses, and the extent to which these responses are linked or distinct among people experiencing depressed mood, anhedonia, and/or anxiety.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for depression and anxiety?
Research shows that cognitive-behavioral therapy (CBT) is highly effective for treating depression and anxiety, with large positive effects compared to other treatments. Mindfulness-based cognitive therapy (MBCT), a part of this treatment, also helps reduce depression relapse, although some people may still experience a return of symptoms.
12345Is Cognitive Behavioral Therapy and its variations safe for humans?
Research indicates that therapies like Mindfulness-Based Cognitive Therapy (MBCT) and Dialectical Behavior Therapy (DBT) are generally safe for humans, as they have been used successfully for various mental health conditions, including depression and anxiety, without significant safety concerns.
678910How is Cognitive Behavioral Therapy + Valuation unique compared to other treatments for depression and anxiety?
Cognitive Behavioral Therapy + Valuation is unique because it combines traditional cognitive behavioral techniques with a focus on personal values, which can help individuals align their actions with what they find meaningful, potentially enhancing motivation and engagement in therapy. This approach is distinct from standard CBT, which primarily focuses on changing thought patterns and behaviors without explicitly incorporating personal values.
1112131415Eligibility Criteria
This trial is for individuals who can see a computer display, are experiencing mood issues, anxiety, or anhedonia (lack of pleasure) that affect their daily life, speak English fluently, and can play simple computer games. It's not for those with MRI contraindications, seizure disorders, significant head injuries, hormone disorders, recent electroconvulsive therapy or chemotherapy treatments for cancer.Inclusion Criteria
I experience mood swings, anxiety, or lack of pleasure that impacts my daily life.
I can see a computer screen clearly.
I can play simple computer games.
+1 more
Exclusion Criteria
I have not had electroconvulsive therapy in the last 5 years.
I have had chemotherapy for cancer before.
I have had seizures, a stroke, or a serious head injury.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo cognitive behavioral therapy and participate in laboratory sessions involving reward/loss learning tasks
12 weeks
Follow-up
Participants are monitored for changes in depression, anxiety, and anhedonia symptoms after treatment
4 weeks
Participant Groups
The study is testing how cognitive behavioral therapy and two types of valuation tasks (with and without instruction) influence the way people perceive rewards and losses. The goal is to understand these processes in those suffering from depressed moods or anxiety.
3Treatment groups
Active Control
Group I: Cognitive behavioral therapyActive Control1 Intervention
cognitive behavioral therapy for depression, anxiety, and/or anhedonia
Group II: Valuation with instructionActive Control1 Intervention
repeat laboratory sessions of a reward/loss learning computer game with specific instructions
Group III: Valuation without instructionActive Control1 Intervention
repeat laboratory sessions of a reward/loss learning computer game without specific instructions
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇦🇺 Approved in Australia as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research Institute at Virginia Tech CarilionRoanoke, VA
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Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
References
An evaluation of Anxiety UK's psychological therapy service outcomes. [2022]Anxiety and depression are highly prevalent. The aim was to examine the effectiveness of Anxiety UK's national psychological therapy service; benchmarking against NHS IAPT data.
Improving outcomes for poorly responding clients: the use of clinical support tools and feedback to clients. [2015]We present two methods of enhancing outcome and preventing treatment failure in psychotherapy. The first involves providing therapists with a decision tree and several assessment measures for clients who are not having a positive response to psychotherapy. The organization of the decision tree and the selection of measures were based on results from psychotherapy outcome studies. The second method involves providing clients with feedback on their progress throughout the course of treatment. Both methods of providing feedback enhanced treatment outcomes and representative studies are reviewed. Use of these methods is recommended for application in routine practice.
Cognitive-Behavioral Treatments for Anxiety and Stress-Related Disorders. [2022]Cognitive-behavioral therapy (CBT) is a first-line, empirically supported intervention for anxiety disorders. CBT refers to a family of techniques that are designed to target maladaptive thoughts and behaviors that maintain anxiety over time. Several individual CBT protocols have been developed for individual presentations of anxiety. The article describes common and unique components of CBT interventions for the treatment of patients with anxiety and related disorders (i.e., panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, prolonged grief). Recent strategies for enhancing the efficacy of CBT protocols are highlighted as well.
The empirical status of cognitive-behavioral therapy: a review of meta-analyses. [2022]This review summarizes the current meta-analysis literature on treatment outcomes of CBT for a wide range of psychiatric disorders. A search of the literature resulted in a total of 16 methodologically rigorous meta-analyses. Our review focuses on effect sizes that contrast outcomes for CBT with outcomes for various control groups for each disorder, which provides an overview of the effectiveness of cognitive therapy as quantified by meta-analysis. Large effect sizes were found for CBT for unipolar depression, generalized anxiety disorder, panic disorder with or without agoraphobia, social phobia, posttraumatic stress disorder, and childhood depressive and anxiety disorders. Effect sizes for CBT of marital distress, anger, childhood somatic disorders, and chronic pain were in the moderate range. CBT was somewhat superior to antidepressants in the treatment of adult depression. CBT was equally effective as behavior therapy in the treatment of adult depression and obsessive-compulsive disorder. Large uncontrolled effect sizes were found for bulimia nervosa and schizophrenia. The 16 meta-analyses we reviewed support the efficacy of CBT for many disorders. While limitations of the meta-analytic approach need to be considered in interpreting the results of this review, our findings are consistent with other review methodologies that also provide support for the efficacy CBT.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.
A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. [2023]Mindfulness-based Cognitive Therapy (MBCT) is a relapse-prevention intervention for people experiencing major depression. Three qualitative meta-syntheses investigating experiences of taking part in MBCT and/or Mindfulness-based Stress Reduction (MBSR) across different diagnostic populations reported themes including control, choice, group processes, relationships and struggles. As multiple studies have been published since, we aimed to update, systematically review and synthesize the experiences of participants with depression taking part in MBCT.
Mindfulness-based cognitive therapy: theory and practice. [2018]Mindfulness-based cognitive therapy (MBCT) incorporates elements of cognitive-behavioural therapy with mindfulness-based stress reduction into an 8-session group program. Initially conceived as an intervention for relapse prevention in people with recurrent depression, it has since been applied to various psychiatric conditions. Our paper aims to briefly describe MBCT and its putative mechanisms of action, and to review the current findings about the use of MBCT in people with mood and anxiety disorders. The therapeutic stance of MBCT focuses on encouraging patients to adopt a new way of being and relating to their thoughts and feelings, while placing little emphasis on altering or challenging specific cognitions. Preliminary functional neuroimaging studies are consistent with an account of mindfulness improving emotional regulation by enhancing cortical regulation of limbic circuits and attentional control. Research findings from several randomized controlled trials suggest that MBCT is a useful intervention for relapse prevention in patients with recurrent depression, with efficacy that may be similar to maintenance antidepressants. Preliminary studies indicate MBCT also shows promise in the treatment of active depression, including treatment-resistant depression. Pilot studies have also evaluated MBCT in bipolar disorder and anxiety disorders. Patient and clinician resources for further information on mindfulness and MBCT are provided.
Dialectical behavior therapy: current indications and unique elements. [2021]Dialectical behavior therapy (DBT) is a comprehensive, evidence-based treatment for borderline personality disorder (BPD). The patient populations for which DBT has the most empirical support include parasuicidal women with borderline personality disorder (BPD), but there have been promising findings for patients with BPD and substance use disorders (SUDs), persons who meet criteria for binge-eating disorder, and depressed elderly patients. Although DBT has many similarities with other cognitive-behavioral approaches, several critical and unique elements must be in place for the treatment to constitute DBT. Some of these elements include (a) serving the five functions of treatment, (b) the biosocial theory and focusing on emotions in treatment, (c) a consistent dialectical philosophy, and (d) mindfulness and acceptance-oriented interventions.
Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]Mindfulness-based cognitive therapy (MBCT) is a programme developed to prevent depression relapse, but has been applied for other disorders. Our objective was to systematically review and meta-analyse the evidence on the effectiveness and safety of MBCT for the treatment of mental disorders.
An exploratory mixed methods study of the acceptability and effectiveness of Mindfulness-Based Cognitive Therapy for patients with active depression and anxiety in primary care. [2022]Mindfulness Based Cognitive Therapy (MBCT) is an 8-week course developed for patients with relapsing depression that integrates mindfulness meditation practices and cognitive theory. Previous studies have demonstrated that non-depressed participants with a history of relapsing depression are protected from relapse by participating in the course. This exploratory study examined the acceptability and effectiveness of MBCT for patients in primary care with active symptoms of depression and anxiety
Using session-by-session measurement to compare mechanisms of action for acceptance and commitment therapy and cognitive therapy. [2018]Debate continues about the extent to which postulated mechanisms of action of cognitive behavior therapies (CBT), including standard CBT (i.e., Beckian cognitive therapy [CT]) and acceptance and commitment therapy (ACT) are supported by mediational analyses. Moreover, the distinctiveness of CT and ACT has been called into question. One contributor to ongoing uncertainty in this arena is the lack of time-varying process data. In this study, 174 patients presenting to a university clinic with anxiety or depression who had been randomly assigned to receive either ACT or CT completed an assessment of theorized mediators and outcomes before each session. Hierarchical linear modeling of session-by-session data revealed that increased utilization of cognitive and affective change strategies relative to utilization of psychological acceptance strategies mediated outcome for CT, whereas for ACT the mediation effect was in the opposite direction. Decreases in self-reported dysfunctional thinking, cognitive "defusion" (the ability to see one's thoughts as mental events rather than necessarily as representations of reality), and willingness to engage in behavioral activity despite unpleasant thoughts or emotions were equivalent mediators across treatments. These results have potential implications for the theoretical arguments behind, and distinctiveness of, CT and ACT.
Cost-utility of individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy compared with treatment as usual in reducing psychological distress in cancer patients. [2021]It was previously determined that group-based face-to-face Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) are equally efficacious compared with treatment as usual (TAU) in reducing psychological distress. In this study, the incremental cost-utility of both interventions compared with TAU was assessed.
Psychotherapy for Major Depressive Disorder and Generalized Anxiety Disorder: A Health Technology Assessment. [2022]Major depressive disorder and generalized anxiety disorder are among the most commonly diagnosed mental illnesses in Canada; both are associated with a high societal and economic burden. Treatment for major depressive disorder and generalized anxiety disorder consists of pharmacological and psychological interventions. Three commonly used psychological interventions are cognitive behavioural therapy (CBT), interpersonal therapy, and supportive therapy. The objectives of this report were to assess the effectiveness and safety of these types of therapy for the treatment of adults with major depressive disorder and/or generalized anxiety disorder, to assess the cost-effectiveness of structured psychotherapy (CBT or interpersonal therapy), to calculate the budget impact of publicly funding structured psychotherapy, and to gain a greater understanding of the experiences of people with major depressive disorder and/or generalized anxiety disorder.
Acceptability, effectiveness and cost-effectiveness of blended cognitive-behavioural therapy (bCBT) versus face-to-face CBT (ftfCBT) for anxiety disorders in specialised mental health care: A 15-week randomised controlled trial with 1-year follow-up. [2023]Anxiety disorders are highly prevalent and cause substantial economic burden. Blended cognitive-behavioural therapy (bCBT), which integrates Internet-based CBT and face-to-face CBT (ftfCBT), is an attractive and potentially cost-saving treatment alternative to conventional CBT for patients with anxiety disorders in specialised mental health care. However, little is known about the effectiveness of bCBT in routine care. We examined the acceptability, effectiveness and cost-effectiveness of bCBT versus ftfCBT in outpatient specialised care to patients with panic disorder, social anxiety disorder and generalised anxiety disorder.
A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety. [2023]Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 (b = -2.75, 95% CI -4.00, -1.50) and GAD-7 (b = -2.79, 95% CI -4.00, -1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm's outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.