Cognitive Behavioral Therapy + Valuation for Depression and Anxiety

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Seizure disorder, Stroke, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

252 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Eligibility 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.

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.

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

Treatment Details

Interventions

• Cognitive Behavioral Therapy
• Valuation with Instruction
• Valuation without Instruction

Trial Overview 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.

Participant Groups

Group I: Cognitive behavioral therapy Active Control 1 Intervention

cognitive behavioral therapy for depression, anxiety, and/or anhedonia

Group II: Valuation with instruction Active Control 1 Intervention

repeat laboratory sessions of a reward/loss learning computer game with specific instructions

Group III: Valuation without instruction Active Control 1 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 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)

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Findings from Research

Anxiety UK's psychological therapy service demonstrated high effectiveness, with recovery and improvement rates surpassing NHS IAPT targets among 957 clients who completed therapy between April 2019 and March 2020.

Cognitive behavioral therapy (CBT) was found to be the most effective method for reducing anxiety, and the results showed that attending more therapy sessions led to greater improvements in both anxiety and depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Anxiety UK's psychological therapy service outcomes. Tham, SG., Lidbetter, N., Pedley, R., et al.[2022]

Implementing a decision tree and assessment measures for therapists can help identify clients who are not responding well to psychotherapy, potentially preventing treatment failure.

Providing clients with regular feedback on their progress during therapy has been shown to enhance treatment outcomes, suggesting that both methods should be integrated into standard psychotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outcomes for poorly responding clients: the use of clinical support tools and feedback to clients. Harmon, C., Hawkins, EJ., Lambert, MJ., et al.[2015]

Cognitive-behavioral therapy (CBT) is recognized as a leading and effective treatment for various anxiety disorders, targeting harmful thoughts and behaviors that contribute to anxiety.

The article discusses both common and unique elements of different CBT protocols tailored for specific anxiety disorders, and it also highlights recent strategies aimed at improving the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Treatments for Anxiety and Stress-Related Disorders. Curtiss, JE., Levine, DS., Ander, I., et al.[2022]

Cognitive Behavioral Therapy (CBT) shows large effect sizes in treating various psychiatric disorders, including unipolar depression, generalized anxiety disorder, and posttraumatic stress disorder, based on a review of 16 rigorous meta-analyses.

CBT is found to be somewhat more effective than antidepressants for adult depression and equally effective as behavior therapy for both adult depression and obsessive-compulsive disorder, highlighting its strong efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Butler, AC., Chapman, JE., Forman, EM., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

Mindfulness-based Cognitive Therapy (MBCT) is effective in helping participants with depression develop skills, increase awareness, and gain a sense of agency over their experiences, as shown in a systematic review of 21 qualitative studies.

Participants reported a mix of acceptance and ambivalence towards their mindfulness practices, indicating that while MBCT can lead to meaningful change, it may also present challenges for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. Williams, K., Hartley, S., Langer, S., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) is effective for preventing relapse in recurrent depression, showing efficacy comparable to maintenance antidepressants, based on several randomized controlled trials.

Preliminary studies suggest that MBCT may also be beneficial for treating active depression, including treatment-resistant cases, as well as in bipolar disorder and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. Sipe, WE., Eisendrath, SJ.[2018]

Dialectical behavior therapy (DBT) is an effective, evidence-based treatment specifically designed for borderline personality disorder (BPD), particularly benefiting parasuicidal women, but also showing promise for those with substance use disorders and binge-eating disorder.

DBT incorporates unique elements such as a focus on emotions, a dialectical philosophy, and mindfulness techniques, which differentiate it from other cognitive-behavioral therapies and are essential for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. Chapman, AL.[2021]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness Based Cognitive Therapy (MBCT) was found to be both acceptable and beneficial for patients with active symptoms of depression and anxiety, with 72% of participants showing improvements in depression scores and 63% in anxiety scores after the 8-week course.

Participants reported significant reductions in their depression (from a mean score of 35.7 to 17.8) and anxiety (from 32.0 to 20.5), indicating that MBCT can effectively reduce symptoms in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Finucane, A., Mercer, SW.[2022]

In a study of 174 patients with anxiety or depression, cognitive behavior therapies (CBT) like cognitive therapy (CT) and acceptance and commitment therapy (ACT) showed different mechanisms of action, with CT relying more on cognitive change strategies and ACT emphasizing acceptance strategies.

Both therapies effectively reduced dysfunctional thinking and increased cognitive 'defusion' and behavioral engagement, suggesting that while CT and ACT may differ in approach, they share common mediators that contribute to their therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using session-by-session measurement to compare mechanisms of action for acceptance and commitment therapy and cognitive therapy. Forman, EM., Chapman, JE., Herbert, JD., et al.[2018]

Both group-based Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) significantly reduced psychological distress in 245 cancer patients compared to treatment as usual (TAU), with improvements in quality of life measured by utility scores.

Both interventions were found to be cost-saving, with eMBCT showing a mean incremental net monetary benefit of €1916 and MBCT €2365 compared to TAU, while maintaining improved quality of life even at the 9-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Compen, F., Adang, E., Bisseling, E., et al.[2021]

Cognitive Behavioral Therapy (CBT), interpersonal therapy, and supportive therapy significantly reduce symptoms of major depressive disorder and generalized anxiety disorder compared to usual care, with CBT also improving anxiety symptoms post-treatment.

Group CBT provided by nonphysicians is the most cost-effective option for treating these disorders, with a projected budget impact of $68 million to $529 million over five years for implementing structured psychotherapy in Ontario.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for Major Depressive Disorder and Generalized Anxiety Disorder: A Health Technology Assessment. [2022]

Blended cognitive-behavioral therapy (bCBT) is an acceptable and clinically effective treatment for anxiety disorders, showing similar effectiveness to face-to-face cognitive-behavioral therapy (ftfCBT) in a study of 114 patients with panic disorder, social anxiety disorder, and generalized anxiety disorder.

bCBT may be a cost-saving alternative to ftfCBT, with similar societal costs and lower direct medical costs, suggesting it could be a more efficient option for treating anxiety disorders in specialized care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Romijn, G., Batelaan, N., Koning, J., et al.[2023]

An 8-week randomized controlled trial with 361 participants showed that internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of depression and anxiety compared to a waiting-list control, with improvements lasting up to 12 months.

iCBT demonstrated potential cost-effectiveness within the UK's Improving Access to Psychological Therapies (IAPT) program, with a 91.2% probability of being cost-effective over 12 months, suggesting it could be a valuable addition to mental health treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety. Richards, D., Enrique, A., Eilert, N., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of Anxiety UK's psychological therapy service outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving outcomes for poorly responding clients: the use of clinical support tools and feedback to clients. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Treatments for Anxiety and Stress-Related Disorders. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The empirical status of cognitive-behavioral therapy: a review of meta-analyses. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

10. England pubmed.ncbi.nlm.nih.gov

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]

11. England pubmed.ncbi.nlm.nih.gov

Using session-by-session measurement to compare mechanisms of action for acceptance and commitment therapy and cognitive therapy. [2018]

12. England pubmed.ncbi.nlm.nih.gov

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]

13. Canada pubmed.ncbi.nlm.nih.gov

Psychotherapy for Major Depressive Disorder and Generalized Anxiety Disorder: A Health Technology Assessment. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

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]

15. England pubmed.ncbi.nlm.nih.gov

A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety. [2023]