Major Depressive DisorderMoodHabNCT06322420
Behavioral Activation for Depression and Habitual Rumination
A study testing Behavioural Activation (BA) in people with Major Depressive Disorder, run by University of Iceland at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Behavioural Activation (BA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIceland
- Study dates
- 9 Feb 2024to 11 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
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.
Read the 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
- Being tested
- Behavioural Activation (BA)
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural Activation (BA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active treatment provided to all participants in the study. Receives: Behavioral: Behavioural Activation (BA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (5)
Symptom severity measured on the PHQ-9
Severity of depressive symptoms measured with the PHQ-9 at post-treatment. The PHQ is as a 9 item self-administered measre for the assessment of the severity of depressive symptoms. Each item is answered with a 4 point likert scale (0-3). The total score ranges from 0-27.
Treatment response is defined as at least a 50% reduction in total symptom severity.
Measured: 1 week
Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule)
Changes in momentary negative and positive affectivity using EMA (Ecological Momentary Assessment) via smartphones measured at post-treatment.
Participants answer 8 multiple choice questions (1-5) eight times per day for six days (pre- and post treatment). Four items represent negative affectivity (NA) and four positive affectivity (PA). In the research group's previous studies, six of the items were used to calculate NA and PA scores, three for NA and three for PA. Consistent with previous research, three items will be used for each scale, thus total score for each scale can range from 3-15.
Additionally the EMA measures will be administrated twice while treatment is ongoing, after session 4 and session 8, where the questions will be answered eight times per day for three days.
Measured: 6 days
Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - 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 6 months follow-up after end of treatment (compared to pre-treatment assessment), assessed by an interviewer using the DIAMOND.
Measured: 2 weeks
Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- 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 presence (or absence) of Major Depressive Disorder in the past 6 months at 6 months follow-up after end of treatment.
Measured: 6 months
The Quality of Life Scale (QOLS)
The QOLS at post-treatment is a 16-item instrument that measured quality of life on a scale from 1-7 and the total score can range is from 16-112.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start9 Feb 2024
- Primary completion11 Jun 2026
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Icelandic Research Center
- Responsible party
- Principal investigator, Ragnar Pétur Ólafsson, University of Iceland
- Investigators
- Ragnar P Ólafsson, PhD, Study chair, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322420
- Sponsor's protocol ID
- MoodHab
- Acronym
- MoodHab
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
- ClinicalTrials.gov ID
- NCT06322420
- Acronym / sponsor ID
- MoodHab / MoodHab
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Icelandic Research Center
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Behavioural Activation (BA)Active treatment provided to all participants in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment |
Primary outcome
Symptom severity measured by the BDI-2
Time frame: 2 weeks
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
Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder
Time frame: 2 weeks
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.
Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode
Time frame: 2 weeks
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.
5 secondary outcomes
Symptom severity measured on the PHQ-9
Time frame: 1 week
Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule)
Time frame: 6 days
Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode
Time frame: 2 weeks
Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder
Time frame: 6 months
The Quality of Life Scale (QOLS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnar P Ólafsson, PhD study chair
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation (BA) in people with Major Depressive Disorder, run by University of Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity measured by the BDI-2 (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.