220 Participants Needed

Behavioral Therapies for Anxiety and Depression

(AAC-BeT Trial)

MC
RL
Overseen ByRobin L Aupperle, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Laureate Institute for Brain Research, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different therapy approaches can help individuals with both anxiety and depression. It will test three therapies: behavioral activation (encouraging engagement in meaningful activities), exposure-based therapy (helping individuals face fears), and supportive therapy (also known as supportive counseling). Researchers seek to understand how these treatments affect brain and behavior responses to rewards and threats. Individuals who experience anxiety and depression as ongoing issues may be well-suited for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective therapies for anxiety and depression.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who regularly use benzodiazepines (a type of medication often used for anxiety). It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that behavioral activation and exposure-based therapy are generally safe and effective for treating anxiety and depression.

For behavioral activation, studies have found that it reduces anxiety and depression symptoms faster than other treatments. People usually tolerate it well, experiencing few negative reactions. One study found no major safety issues, making it a reliable choice for those with depression.

Exposure-based therapy is also proven safe. It is often used for anxiety disorders and is considered one of the best treatments available. Although the therapy involves facing fears and might seem tough initially, most people manage it well. Research has shown it works even in challenging situations, such as in communities with fewer resources, without causing harm.

Both treatments are well-researched and have been shown to be safe options for those dealing with anxiety and depression.12345

Why are researchers excited about this trial?

Researchers are excited about these behavioral therapies for anxiety and depression because they offer unique approaches compared to traditional medication-based treatments. Behavioral Activation encourages individuals to engage in meaningful activities to boost their mood, while Exposure-based therapy focuses on helping patients face their fears in a controlled manner to reduce anxiety over time. Supportive therapy provides emotional support and encouragement, helping patients build coping skills and resilience. These methods have the potential to empower patients with tools to manage their symptoms actively, offering an alternative or complement to standard pharmacological treatments.

What evidence suggests that this trial's treatments could be effective for anxiety and depression?

This trial will compare different behavioral therapies for anxiety and depression. Research has shown that both behavioral activation and exposure-based therapy, tested in this trial, effectively treat these conditions. Participants may receive Behavioral Activation, which improves mood and reduces anxiety by encouraging engagement in meaningful activities. Studies have found it helpful for various mental health issues, including depression and anxiety disorders. Alternatively, participants may receive Exposure-based therapy, which effectively reduces anxiety by helping individuals face and overcome fears, addressing avoidance and negative thinking patterns. Both therapies have demonstrated improvements in mental health, making them promising options for treating anxiety and depression.678910

Who Is on the Research Team?

RL

Robin L Aupperle, PhD

Principal Investigator

Laureate Institute for Brain Research

Are You a Good Fit for This Trial?

This trial is for individuals who experience both anxiety and depression, scoring above 55 on the PROMIS scales for these conditions. They must be able to give informed consent, speak English well enough for the study's procedures, and consider their symptoms a clinical concern. People with severe mental health issues like bipolar or psychotic disorders, recent substance abuse, neurological disorders, MRI contraindications (like metal implants), or regular benzodiazepine use cannot participate.

Inclusion Criteria

Sufficient English proficiency to complete procedures
Score >55 on both the PROMIS Anxiety and PROMIS Depression scales
Able to provide informed consent
See 2 more

Exclusion Criteria

I have been diagnosed with a neurological disorder.
History of moderate to severe substance use disorder over the past year
I have vision or hearing problems that haven't been corrected.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three therapy interventions: behavioral activation, exposure-based therapy, or supportive therapy. Clinical, self-report, behavioral, and fMRI assessments are conducted before and after therapy.

14-18 weeks

Follow-up

Participants are monitored for changes in mental health symptoms and brain responses after therapy completion.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation
  • Exposure-based therapy
  • Supportive therapy
Trial Overview The AAC-BeT trial tests how different therapies—behavioral activation (enhancing engagement in meaningful activities), exposure-based therapy (reducing avoidance of negative expectations), and supportive therapy—affect decision-making in those with anxiety and depression. Participants will undergo brain imaging (fMRI) and behavioral assessments before and after treatment to see which approach works best.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Exposure-based therapyExperimental Treatment1 Intervention
Group II: Behavioral activationExperimental Treatment1 Intervention
Group III: Supportive therapyActive Control1 Intervention

Behavioral Activation is already approved in United States, China, European Union for the following indications:

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Approved in United States as Behavioral Activation Therapy for:
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Approved in China as Behavioral Activation Therapy for:
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Approved in European Union as Behavioral Activation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials
53
Recruited
5,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Behavioral activation is an effective treatment for depression that focuses on increasing positive activities to counteract negative mental states, making it a fundamental mechanism for change in various psychological disorders.
This approach can be integrated into many forms of psychotherapy, potentially speeding up treatment and improving outcomes across a wide range of mental health issues, from chronic pain to personality disorders.
Behavioral activation as a common mechanism of change across different orientations and disorders.Dimaggio, G., Shahar, G.[2018]
Behavioral activation is an effective treatment for depression that focuses on increasing engagement in pleasurable and meaningful activities, and it can be used alone or alongside antidepressant medications.
The method involves activity monitoring to help patients track their behaviors and moods, which aids in identifying patterns that contribute to their depression, making it a versatile approach even for those with other mental health issues like psychosis.
Behavioral activation: a strategy to enhance treatment response.Sudak, DM., Majeed, MH., Youngman, B.[2014]
Behavioral activation (BA) is an effective standalone psychotherapy for depression, showing comparable efficacy to traditional cognitive-behavioral therapy (CBT) and is recognized as an evidence-based guided self-help intervention.
Further research is needed to understand the neurobiological mechanisms behind BA and to assess the potential for integrating e-mental health applications of BA into China's public healthcare system.
A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression.Wang, X., Feng, Z.[2022]

Citations

Is behavioural activation an effective treatment for ...Individuals who received Self-Control Therapy demonstrated the highest reductions in anxiety at post-treatment. Several other anxiety measures ...
Comparing the effectiveness of behavioral activation in ...The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...
Behavioral Activation and Brain Network Changes in ...BA treatment has been found to be effective for depression, anxiety disorders,164 posttraumatic stress disorder,165 schizophrenia,166 ...
Effectiveness of Digital Behavioral Activation Interventions ...Digital BA interventions significantly reduced depressive symptoms at 2 months (P<.001, I²=0%), 3 months (P=.001, I²=51%), and 6 months (P=.009, ...
Effectiveness of behavioral activation and mindfulness in ...Two-week online behavioral activation and mindfulness reduce depression. Potential maintaining factors, such as reward sensitivity and anhedonia, were improved.
Efficacy and safety of behavioural activation on depression ...For medium-term efficacy, behavioural activation showed a Hedges' g of −0.11 (95% CI: −0.45 to 0.23) compared with control groups. The meta-analysis results, ...
Behavioral activation is one of the most important CBT ...Behavioral activation helps us understand how behaviors influence emotions, just like cognitive work helps us understand the connection between thoughts and ...
A randomized clinical trial of behavioral activation and ...Meta-analyses have demonstrated that EXP is highly effective for anxiety [6], [17]. For GAD in particular, EXP has been shown to effectively reduce behavioral ...
A randomized clinical trial of behavioral activation and ...Compared to EXP, BA yielded more rapid declines in anxiety and depression scores during therapy (d=0.75–0.77), as well as lower anxiety and depression scores (d ...
Behavioral activation for anxiety disorders. - APA PsycNetAccumulating data suggest that behavioral activation interventions may be an effective approach to treating clinical depression.
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