Behavioral Activation for Depression and Habitual Rumination

NCT ID: NCT06322420

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2027-02-01

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.

Detailed Description

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 (estimated number of participants is from 90 to 120) in 12 treatment sessions over 11 weeks. Measures are obtained at pre-treatment, during treatment (in sessions and during two assessment windows after session 4 and 8), at post-treatment and at 6 month follow up. Multimodal assessment of key constructs will be used in the study, including clinician ratings using semi-structured diagnostic interviews, self-report questionnaires, experimental tasks and ecological momentary assessment to capture moment-to-moment changes during the flow of daily life. Our main research questions are: 1) Does BA lead to reduction in depressive symptoms and diagnostic status, and are these symptom changes mediated by changes in habit-like mood-reactive ruminative thinking? 2) Are treatment gains and possible mediation of habit-like ruminative thinking, moderated by history of early-life stress and cognitive flexibility, that both have been established as predisposing factors for symptom onset in depression and are also know moderators of the development of rumination as a habit? 3) Does perceived control and reward-related responses increase during BA and are these changes associated with rumination as a habit? 4) Are gains during treatment maintained at 6-month follow up after treatment completion?

Moderators measured at pre-treatment: :

History of early life stess (total and physical/sexual/emotional abuse in particular), measured with the The Childhood Traumatic Event Scale (CTES) and The Adverse Childhood Experiences (ACEs) Questionnaire.

Cognitive flexibility: The Standard version of the Verbal Fluency Test (VFT), The Trail Making Test (TMT) and Digit-Span will be administered.

Mediators measured at pre-treatment, during treatment, post-treatment and follow up:

Depressive rumination will be measured with the brooding and reflective pondering subscales of the Ruminative Response Scale (RRS).

Habitual characteristics of ruminative thinking will be measured with the Habit Index of Negative Thinking (HINT).

Perceived control will be measured with the Pearlin Mastery Scale (PMS).

Reward-related responding will be measured with the Environmental Reward Observation Scale (EROS).

Level of activation will be measured with the Behavioral Activation for Depression Scale (BADS).

Selected items from the RRS, PMS, EROS and BADS are administered along the PHQ-9 at start of all treatment sessions in the study.

State ruminative thinking, perceived control, reward-related responding and level of activation will also be measured 8 times per day during ecological momentary assessment via smartphones for six days at pre-treatment and post-treatment and for three days at two assessment windows during treatment.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Active treatment provided to all participants in the study.

Group Type: EXPERIMENTAL

Behavioural Activation (BA)

Intervention Type: 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.

Interventions

Behavioural Activation (BA)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Icelandic Centre for Research

UNKNOWN

Sponsor Role: collaborator

Ragnar Pétur Ólafsson

OTHER

Sponsor Role: lead

Responsible Party

Ragnar Pétur Ólafsson

Professor at the Faculty of Psychology, University of Iceland

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ragnar P Ólafsson, PhD

Role: STUDY_CHAIR

University of Iceland

Locations

University of Iceland

Reykjavik, Iceland, Iceland

Site Status: RECRUITING

Countries

Iceland

Central Contacts

Ragnar P Ólafsson, PhD

Role: CONTACT

ragnarpo@hi.is

8622245 ext. 00354

Sigurður Viðar, Cand.Psych

Role: CONTACT

siv1@hi.is

8641751 ext. 00354

Facility Contacts

Ragnar P Ólafsson, PhD

Role: primary

ragnarpo@hi.is

8622245 ext. 00354

Other Identifiers

MoodHab

Identifier Type: -

Identifier Source: org_study_id