Behavioral Activation for Depression and Habitual Rumination

NCT06322420 | Recruiting

• 1 other identifier: MoodHab
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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.

Other Outcomes (8)

• Generalized Anxiety Disorder-7 (GAD-7)

  2 weeks

• The Snaith-Hamilton Pleasure Scale (SHAPS)

  2 weeks

• Beck Anxiety Inventory (BAI)

  1 week

Study Arms (1)

Treatment

EXPERIMENTAL

Active treatment provided to all participants in the study.

Behavioral: Behavioural Activation (BA)

Interventions

Behavioural Activation (BA) BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ragnar Pétur Ólafsson: lead
• The Icelandic Centre for Research: collaborator

Study Sites (1)

University of Iceland

Reykjavik, Iceland, 102, Iceland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ragnar P Ólafsson, PhD

  University of Iceland

  STUDY CHAIR

Central Study Contacts

Ragnar P Ólafsson, PhD

CONTACT

8622245; ragnarpo@hi.is

Sigurður Viðar, Cand.Psych

CONTACT

8641751; siv1@hi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor at the Faculty of Psychology, University of Iceland

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 21, 2024
• Study Start: February 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

IC (1)