Self-help Tools for Depression

Overseen By Isabel Berwian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Princeton University

Disqualifiers: Attention issues, Identity check failure

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

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

1500 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Self-help information based on principles of behavioral activation and cognitive restructuring for depression?

Research shows that behavioral activation, a key part of this treatment, is effective for depression and can be as helpful as traditional cognitive-behavioral therapy (CBT). It helps people engage in activities that improve their mood and motivation. ^{1 2 3 4 5}

Is behavioral activation safe for humans?

Behavioral activation, a treatment for depression, has been used safely since the 1970s and is considered straightforward and easy to understand. It is often used alone or with medication, and no safety concerns have been highlighted in the research. ^{2 3 6 7 8}

How is the self-help treatment for depression unique compared to other treatments?

This self-help treatment for depression is unique because it combines principles of behavioral activation (encouraging engagement in rewarding activities) and cognitive restructuring (changing unhelpful thoughts) into a self-guided format, empowering patients to manage their own therapy without direct therapist intervention. ^{2 5 6 9 10}

What is the purpose of this trial?

The study aims to examine whether the investigators can predict, on the level of individual participants who have symptoms of depression, who will benefit more from self-help tools based on principles of behavioral activation vs. cognitive restructuring, in terms of a greater decrease of self-reported symptoms. The investigators use a combination of self-reported clinical information and behavior on learning and decision-making tasks to predict change in symptom scores.

Eligibility Criteria

This trial is for English-speaking individuals who want to improve their mood, reduce negative thoughts or symptoms of depression, and are willing to verify their identity on a video call. It's not suitable for those who can't pay attention during the study, aren't honest, or fail an identity check.

Inclusion Criteria

Having a picture ID and be willing to meet with us on a video zoom call for identity verification if invited to do so

Fluent in English

I want to improve my mood and reduce depression symptoms.

Exclusion Criteria

Identity check failure

Lack of attention when completing parts of the study, lack of honesty or not completing parts of the study in a timely way

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening and consent

Treatment

Participants engage with the self-help tool e-couch for 5 weeks, completing either cognitive restructuring or behavioral activation modules

5 weeks

Online engagement with self-help tool

Mid-treatment Assessment

Participants complete behavioral tasks and symptom self-report questionnaires to assess progress

1 week

Online assessment

Follow-up

Participants are monitored for changes in symptoms at various intervals after the treatment period

48 weeks

Online assessments at 1, 3, 5, 12, 24, and 48 weeks

Treatment Details

Interventions

• Self-help information based on principles of behavioral activation
• Self-help information based on principles of cognitive restructuring

Trial Overview The study tests two self-help tools for depression: one based on cognitive restructuring and another on behavioral activation. It aims to predict which tool better reduces symptoms by analyzing participants' self-reports and behavior in tasks.

Participant Groups

Group I: Cognitive restructuring group Experimental Treatment 1 Intervention

Participants will read information and engage in exercises through the self-help tool e-couch that aim at tackling negative thinking.

Group II: Behavioral activation group Experimental Treatment 1 Intervention

Participants will read information and engage in exercises through the self-help tool e-couch that aim at stimulating their engagement in pleasant activities.

Who Is Running the Clinical Trial?

Trustees of Princeton University

Lead Sponsor

Trials

2

Recruited

1,700+

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 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]

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: a strategy to enhance treatment response. Sudak, DM., Majeed, MH., Youngman, B.[2014]

In a study of 313 patients with major depressive disorder, internet-based behavioral activation significantly reduced depressive symptoms by increasing engagement in enjoyable activities, with a measurable effect observed after 4 weeks.

The findings suggest that clinicians and patients should expect a 4-week period for activation levels to improve before seeing a notable reduction in depression symptoms, which typically occurs around 6 weeks into the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. Fu, Z., Burger, H., Arjadi, R., et al.[2022]

Cognitive Behavioral Therapy (CBT) employs active and collaborative strategies, such as cognitive restructuring, to help patients identify and change unhelpful thoughts that contribute to emotional distress.

CBT also includes techniques like behavioral activation to encourage engagement in pleasurable activities, exposure therapy to reduce fear responses, and problem-solving to systematically tackle life challenges, making it a comprehensive approach for treating various mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic Strategies of Cognitive Behavioral Therapy. Wenzel, A.[2018]

References

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

Behavioral activation and rehabilitation. [2022]

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Functional improvement by behavioural activation for depressed older adults. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Inpatient behavior therapy of depression--a multimodal approach in clinical practice]. [2006]

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

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

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

Behavioral activation: a strategy to enhance treatment response. [2014]

8. Germany pubmed.ncbi.nlm.nih.gov

Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. [2022]

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

Cognitive restructuring, behavioral activation and cognitive-behavioral therapy in the treatment of adult depression: A network meta-analysis. [2022]

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

Basic Strategies of Cognitive Behavioral Therapy. [2018]