Psychotherapy for Depression

Overseen By Zachary Stewart

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Benzodiazepines

Disqualifiers: Suicidal ideation, Psychosis, Autism, others

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

Compensation: Varies

Number of Visits: 3

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain activities of clients and therapists might synchronize during a therapy session for depression. Participants will experience one of two approaches: Behavioral Activation, which involves personalized goal-setting to improve mood, or Psychoeducation, which provides general information on managing depression. Ideal participants are full-time students dealing with mild to moderate depression who can understand English.

As an unphased study, this trial offers participants the opportunity to contribute to innovative research that could enhance therapeutic techniques for 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 participants who take more than 20 mg of benzodiazepines daily. It's best to discuss your specific medications with the study team.

What prior data suggests that these psychosocial interventions are safe for treating depression?

Research has shown that both Behavioral Activation and Psychoeducation are generally safe for treating depression, with a low risk of harm.

Behavioral Activation involves working with a therapist to set personal goals and replace negative habits with positive ones. Studies have found it often helps reduce depression symptoms and is usually well-tolerated, with few reports of negative effects.

Psychoeducation provides information on managing depression. It helps people understand their symptoms and learn ways to feel better. Like Behavioral Activation, it is considered safe, with minimal reports of negative effects.

In summary, both treatments are safe options for managing depression symptoms. Various studies have used them with positive outcomes and minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they offer unique approaches to managing depression. Unlike traditional treatments like antidepressant medications and cognitive behavioral therapy, Behavioral Activation focuses on actively engaging patients in setting personalized goals and modifying behaviors to increase exposure to positive experiences, potentially addressing the root causes of depressive symptoms more directly. On the other hand, Psychoeducation provides patients with general knowledge and evidence-based strategies for managing depression, serving as a valuable control that emphasizes understanding and awareness. These approaches are promising because they empower patients to take an active role in their recovery, which might lead to more sustainable long-term outcomes.

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

Research has shown that Behavioral Activation (BA), one of the treatments in this trial, effectively treats depression. A review of several studies found that BA reduces depression symptoms, with patients experiencing significant improvements. BA sets personalized goals and replaces negative habits with positive ones. Studies suggest BA is as effective at reducing immediate depression symptoms and preventing their return.

Psychoeducation, another treatment arm in this trial, provides general information about depression and its management. Used as a comparison in this study, it does not offer personalized treatment like BA. While it provides helpful strategies, its effectiveness in reducing depression symptoms is generally considered less significant than BA. ^{6 7 8 9 10}

Who Is on the Research Team?

Flavio Frohlich

Principal Investigator

Carolina Center for Neurostimulation

Are You a Good Fit for This Trial?

This trial is for individuals experiencing stress, depression, or anxiety. Participants should be willing to discuss their mental and physical health, attend a therapy session where their brain activity will be measured, and complete follow-up surveys.

Inclusion Criteria

Participants/clients must have no current suicidal ideation in the past month as determined by the Columbia Suicidality Severity Rating Scale

I understand the study procedures and can give informed consent.

My therapist is approved by the study's lead researcher.

Exclusion Criteria

Participants/clients with active, current suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale in the past month

Participants/clients with a past suicide attempt (lifetime)

Participants/clients with anything in the assessment of the study team that will not lead to successful completion of study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants attend a single 60-minute psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement

1 day

1 visit (in-person)

Follow-up

Participants complete follow-up surveys to assess changes in depression symptoms and therapeutic alliance

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation
• Psychoeducation

Trial Overview The study aims to compare the effects of Behavioral Activation (a type of cognitive-behavioral therapy) with Psychoeducation on people with depression symptoms by measuring how well client-therapist brain activities sync during sessions.

How Is the Trial Designed?

Group I: Behavioral Activation Experimental Treatment 1 Intervention

Behavioral Activation (BA) is a psychotherapy modality that can be used to treat depression. The 60 minute session of BA is designed to actively engage with the client in creating personalized goals and ways in which maladaptive coping mechanisms maintaining depression can be addressed and replaced with increased exposure to positive reinforcement.

Group II: Psychoeducation Active Control 1 Intervention

Psychoeducation will be used in this study as a control condition. The 60 minute session will be structured to provide general educational information on depression and evidence-based strategies to reduce symptoms. The information will be presented in generic format and will not be tailored to be client-specific.

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

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Foundation of Hope, North Carolina

Collaborator

Trials

18

Recruited

670+

Published Research Related to This Trial

In a study of 154 children aged 3 to 16 receiving 24 months of applied behavior analysis (ABA) for autism spectrum disorder, there was limited agreement between patient-centered measures and standard outcome measures of treatment progress.

Despite an increase in children achieving meaningful gains on patient-centered goals over time, the standard measure of adaptive behavior showed a decline, highlighting the need for ongoing communication between clinicians and families to ensure treatment aligns with meaningful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance between patient-centered and adaptive behavior outcome measures after applied behavior analysis for autism. Choi, KR., Lotfizadah, AD., Bhakta, B., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. Wang, X., Feng, Z.[2022]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

The study found that patients generally had a positive experience with Brief Behavioral Activation Treatment for Depression (BATD) delivered in a group setting, highlighting helpful aspects like motivation, goal setting, and activity scheduling.

Patients provided mixed feedback on certain elements, such as the focus on depression and the balance between lecture and participation, indicating areas for improvement in the group therapy format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient experiences with group behavioural activation in a partial hospital program. Stein, AT., Tian, L., Cuthbert, K., et al.[2021]

A study involving 128 participants with major depressive episodes found that a Health Action Process Approach (HAPA)-based internet-delivered behavioral activation intervention significantly reduced clinician-rated depressive symptoms compared to a control group, with a strong effect size at 8 weeks (d = 0.79).

The intervention group also showed improvements in self-rated depressive symptoms, behavioral activation, and various motivational and volitional outcomes, indicating that the HAPA framework effectively enhances treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. Mueller-Weinitschke, C., Bengel, J., Baumeister, H., et al.[2023]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its potential as a treatment for vulnerable populations.

Interestingly, the specific types or amounts of activities (functional, pleasurable, or social) did not significantly correlate with symptom improvement, suggesting that simply engaging in activities to counter avoidance may be key to the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. Hershenberg, R., Paulson, D., Gros, DF., et al.[2015]

In a randomized controlled trial involving 108 patients in Pakistan, culturally adapted Behavioral Activation therapy for Muslims (BA-M) was found to be more effective than Cognitive Behavior Therapy (CBT) in reducing depression symptoms, with a significant improvement of 1.95 units in PHQ-9 scores (P = 0.006).

Patients receiving BA-M also experienced better retention in therapy, attending an average of 0.75 more sessions than those in the CBT group (P = 0.013), and showed significant improvements in quality of life across physical, psychological, and social domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of a culturally adapted behavioral activation therapy for Muslim patients with depression in Pakistan. Dawood, S., Mir, G., West, RM.[2023]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618157/

Is behavioural activation an effective treatment for ... A meta-analysis of 4 RCTs (n = 156) showed that BA has a small effect of 0.24 (Hedge's adjusted g) in reducing depression symptoms compared to a ...

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05973-z

Comparing the effectiveness of behavioral activation in group ... The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...

3. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2024.0148

Behavioral Activation and Brain Network Changes in ... 3 These findings suggest that BA treatment is at least as effective in improving acute depressive symptoms and preventing relapse as the ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/10503307.2023.2197630

Individual behavioral activation in the treatment of depression Although the quality of most of the trials was modest, this meta-analysis suggested that BA is an effective treatment for depression as well as other outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0005796723002036

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021889/

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, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2882847/

Behavioral activation interventions for well-being: A meta- ... These results provide evidence that BA interventions can increase the well-being of recipients and that they are equally effective regardless of depression ...

8. medicine.umich.edu medicine.umich.edu/sites/default/files/content/downloads/Behavioral-Activation-for-Depression.pdf

Behavioral Activation for Depression Note: Behavioral Activation has been shown in research studies to be effective on its own for some people to overcome depression. However, it is often used ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2950004423000044

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 ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005791624000727

An online group behavioral activation therapy for major ... A ten-session online group BAT program significantly reduced depressive symptoms in this pre-post trial. · Online group BAT increased behavioral activation ...