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

Trial Summary

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 data supports the effectiveness of the treatment Behavioral Activation for depression?

Research shows that Behavioral Activation (BA) is an effective treatment for depression, with studies highlighting its success as a standalone therapy. It involves techniques like activity scheduling and skills training, which have been proven to help improve depressive symptoms. ^{1 2 3 4 5}

Is psychotherapy for depression, including Behavioral Activation and similar therapies, generally safe for humans?

The research articles provided do not contain specific safety data for psychotherapy treatments like Behavioral Activation or similar therapies for depression. However, they discuss the importance of risk assessment and safety models in behavior analysis, which suggests that safety is a considered aspect in the field. ^{6 7 8 9 10}

How is Behavioral Activation different from other treatments for depression?

Behavioral Activation (BA) is unique because it focuses on helping people engage in activities that bring them pleasure or a sense of achievement, which can improve mood and motivation. Unlike some therapies that require extensive psychological training, BA can be delivered by practitioners with less training, making it accessible in low-resource settings. ^{1 5 11 12 13}

What is the purpose of this trial?

The goal of this study is to learn the extent to which client-therapist brain activity may synchronize during a psychosocial intervention for depression symptoms. The study will compare behavioral activation, a client-centered type of cognitive-behavioral therapy, to psychoeducation which delivers information on strategies to recover from depression symptoms. Participants will answer questions about their mental and physical health, attend one psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement and complete follow up surveys two weeks and one month following the intervention.

Research Team

Flavio Frohlich

Principal Investigator

Carolina Center for Neurostimulation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2023]

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

What is behavioral activation? A review of the empirical literature. [2022]

3. United States 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. [2015]

4. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Toward the Development of a Functional Analysis Risk Assessment Decision Tool. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Concordance between patient-centered and adaptive behavior outcome measures after applied behavior analysis for autism. [2023]

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

Using e-learning modules to teach ongoing-visual inspection of functional analyses. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Behavioral Safety Model for Clinical Settings: Coaching for Institutionalization. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Public Perception of Behavior Analysis. [2018]

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

Patient experiences with group behavioural activation in a partial hospital program. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

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

Randomized control trial of a culturally adapted behavioral activation therapy for Muslim patients with depression in Pakistan. [2023]