NCT06322420|Active Not Recruiting
Behavioral Activation for Depression and Habitual Rumination
MoodHab
Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
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MoodHab
Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
Sponsor study identifier
interventional
120
1 country
1
Study Start
February 9, 2024
Actual (reported)Primary Completion
June 11, 2026
Actual (reported)Study Completion
December 11, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 11, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2024
Actual (reported)February 9, 2024
Actual (reported)March 21, 2024
Actual (reported)June 11, 2026
Actual (reported)December 11, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Symptom severity measured by the BDI-2
Severity of depressive symptoms as defined by BDI-2 (self-report rating). The BDI-2 will be administrated pre- and post treatment as a primary outcome measure. Additionally it will also be administrated after session 4 and session 8 and in a follow up measure 6 months after treatment ends. The BDI-2 is a 21 item self report scale. Each item is answered with a 4 point likert scale (0-3). The total score ranges from 0-63. Treatment response is defined as at least a 50% reduction in total symptom severity
2 weeks
Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder
The DIAMOND interview is intended to be used with adults (age 18 and up) with known or suspected Mood, Anxiety, or Obsessive- Compulsive and Related Disorders. The DIAMOND provides information on the diagnostic status and current severity for all disorders assessed in the interview according to DSM-5 criteria. This outcome is defined as severity (distress/impairment) of Major Depressive Disorder on a scale from 1-7 (normal, borderline, mild, moderate, marked, severe or extreme) at post-treatment (compared to pre-treatment assessment) assessed by an interviewer using the DIAMOND.
2 weeks
Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode
The DIAMOND interview is intended to be used with adults (age 18 and up) with known or suspected Mood, Anxiety, or Obsessive- Compulsive and Related Disorders. The DIAMOND provides information on the diagnostic status and current severity for all disorders assessed in the interview according to DSM-5 criteria. This outcome is defined as presence (or absence) of Major Depressive Episode in the past two weeks at post-treatment (compared to pre-treatment assessment), assessed by an interviewer using the DIAMOND.
2 weeks
Symptom severity measured on the PHQ-9
1 week
Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule)
6 days
Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode
2 weeks
Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder
6 months
The Quality of Life Scale (QOLS)
The QOL asks about how people experience their quality of life in the present, it will bee submitted through study completion, an average of 9 months, pre treatment, post treatment and in a 6 month follow up.
Generalized Anxiety Disorder-7 (GAD-7)
2 weeks
The Snaith-Hamilton Pleasure Scale (SHAPS)
2 weeks
Beck Anxiety Inventory (BAI)
1 week
Active treatment provided to all participants in the study.
Behavioural activation treatment delivered in this single arm study. Individual treatment given to all participants in 12 sessions over 11 weeks. All treatment components have been introduced by session 8 that defines minimum amount of treatment in the trial (i.e. 8 session completed). Behavioral Activation is a psychological treatment for depression focused on gradually re-engaging people with sources of reinforcement and reward in their environment by re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Iceland
Reykjavik, Iceland, 102, Iceland
Ragnar P Ólafsson, PhD
University of Iceland
First Submitted
February 8, 2024
First Posted
March 21, 2024
Study Start
February 9, 2024
Actual (reported)Primary Completion
June 11, 2026
Actual (reported)RESISTance Exercise for Depression Trial
Contact the study team to confirm eligibility.
Study Completion
December 11, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 26, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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