Behavioral Activation for treating depression and rumination

Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression

This study is testing if a special therapy called Behavioral Activation can help people with depression who often get stuck in negative thoughts, by providing them with personalized treatment over 12 sessions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Iceland (other)
• Locations: 1 site (Reykjavik, Iceland)
• Trial ID: NCT06322420 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Behavioral Activation (BA) on individuals suffering from Major Depressive Disorder, particularly focusing on how habitual rumination influences treatment outcomes. Participants will receive individualized BA treatment over 12 sessions spanning 11 weeks, with assessments conducted at various stages to monitor changes in depressive symptoms and rumination patterns. The study aims to identify key factors that may moderate treatment effectiveness, such as early life stress and cognitive flexibility, using a multimodal assessment approach that includes clinician ratings and self-report questionnaires.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who are currently experiencing a major depressive episode and have a significant level of depressive symptoms.

Not a fit: Patients with a history of manic or hypomanic episodes, psychotic disorders, or recent substance abuse may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce depressive symptoms and improve coping strategies for patients with Major Depressive Disorder.

How similar studies have performed: Previous studies have shown that Behavioral Activation is an effective treatment for depression, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Current major depressive episode according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview, that is considered to be the primary diagnosis.
2. Sore of 14 or higher on Becks Depression Inventory-II (BDI-II) that measures severity of symptoms of depression past 2 weeks.
3. Participants are between 18 and 65 years of age at start of study.
4. Satisfactory understanding of the Icelandic language to complete measures in the study.
5. Completion of pre-treatment assessment that includes 2 visits to researchers and a 6-day ecological momentary assessment.

Exclusion Criteria:

1. Current or past manic or hypomanic episodes according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
2. Current or past psychotic disorders according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
3. Presence of substance abuse within the last 12 months according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
4. Presence of active and serious suicidal thoughts or a suicidal attempt in the previous 2 months.
5. Unstable medical treatment for depression (type of drug and/or dosing) during past two months at pre-treatment assessment.
6. Recent psychotherapy within the past month at pre-treatment assessment or active psychotherapy during study participation.
7. Cognitive impairments or severe physical illness.

Where this trial is running

Reykjavik, Iceland

• University of Iceland — Reykjavik, Iceland, Iceland (RECRUITING)

Study contacts

• Study coordinator: Ragnar P Ólafsson, PhD

Conditions: Major Depressive Disorder, Depression