Behavioral Activation for Depression and Habitual Rumination (NCT06322420) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Behavioral Activation for Depression and Habitual Rumination
Iceland120 participantsStarted 2024-02-09
Plain-language summary
Depressive rumination, a negative thinking style characterized by repetitive and passive thoughts about the causes, meanings, and consequences of one's feelings and distress, is often described as being a habitual response tendency that forms a vulnerability to depression. Behavioural Activation (BA) is an effective treatment for depression but little is known of mechanisms of changes during a successful treatment completion and for whom the treatment benefits the most. The main purpose of the study is to investigate whether habit-like mood-reactive rumination will change during Behavioral Activation treatment for current depression and mediates symptom changes in the treatment. Important moderators of change will also be investigated (i.e. history of early life stress and cognitive flexibility). We aim to provide individual BA treatment for up to 120 currently depressed participants (from 90 to 120 participants) in 12 treatment sessions over 11 weeks. Measures are obtained at pre-treatment, during treatment, at post-treatment and at 6 month follow up.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Sore of 14 or higher on Becks Depression Inventory-II (BDI-II) that measures severity of symptoms of depression past 2 weeks.
. Participants are between 18 and 65 years of age at start of study.
. Satisfactory understanding of the Icelandic language to complete measures in the study.
. Completion of pre-treatment assessment that includes 2 visits to researchers and a 6-day ecological momentary assessment.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something called Behavioral Activation specifically for depression combined with habitual rumination — does that match my situation, and is rumination a significant part of what I'm experiencing?
2The trial is no longer recruiting new participants — are there similar behavioral activation studies currently open that I might be eligible for, or would this approach be available to me outside of a research setting?
3Since this is listed as Phase NA, which often means it's studying a behavioral or psychological intervention rather than a drug, what does the evidence currently look like for Behavioral Activation compared to medication or other therapy options for my type of depression?
4The trial measures symptom severity using a tool called the BDI-2 and also uses structured diagnostic interviews — if I were evaluated the same way right now, how would my current severity level compare to what this study was designed to treat?
5Given that this trial focuses on a specific psychological technique rather than medication, would you recommend I try a standard treatment like antidepressants or CBT first, or does Behavioral Activation seem like a reasonable path to explore given my symptoms?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom severity measured by the BDI-2
Timeframe: 2 weeks
2
Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder
Timeframe: 2 weeks
3
Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode