Clinical trial NCT06322420: Behavioral Activation for Depression and Habitual Rumination
Official title: Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: The Icelandic Centre for Research
First posted: 2024-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptom severity measured by the BDI-2
timeFrame: 2 weeks
measure: Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder
timeFrame: 2 weeks
measure: Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptom severity measured on the PHQ-9
timeFrame: 1 week
measure: Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule)
timeFrame: 6 days
measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode
timeFrame: 2 weeks
measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder
timeFrame: 6 months
measure: The Quality of Life Scale (QOLS)
timeFrame: 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:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 2 weeks
measure: The Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 2 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: 1 week
measure: The Ruminative Response Scale (RRS)
timeFrame: The RRS asks about peoples rumination in the present, it will bee submitted through study completion, an average of 9 months, pre treatment, in treatment, post treatment and in a 6 month follow up.
measure: The Pearlin Mastery Scale (PMS)
timeFrame: The PMS asks about how people regard their perceived control in the present, it will bee submitted through study completion, an average of 9 months, pre treatment, in treatment, post treatment and in a 6 month follow up.
measure: The Environmental Reward Observation Scale (EROS)
timeFrame: 4 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: 1 week
measure: Habit Index of Negative Thinking (HINT)
timeFrame: The HINT asks about habitual charectaristics in the present, it will bee submitted through study completion, an average of 9 months, pre treatment, in treatment, post treatment and in a 6 month follow up.
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland
Study officials:
affiliation: University of Iceland
name: Ragnar P Ólafsson, PhD
role: STUDY_CHAIR
References: