Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322420
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-02-08
Brief Title:
Behavioral Activation for Depression and Habitual Rumination
Sponsor:
Ragnar Pétur Ólafsson
Organization:
University of Iceland
Study Overview
Official Title:
Mood-reactive Habitual Rumination and Changes During Behavioral Activation Treatment for Major Depression
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoodHab
Brief Summary:
Depressive rumination a negative thinking style characterized by repetitive and passive thoughts about the causes meanings and consequences of ones 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 ie 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 ones 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 ie 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 physicalsexualemotional 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
Moderators measured at pre-treatment
History of early life stess total and physicalsexualemotional 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None