NCT04595539

Brief Summary

This study aims to investigate the combine effects of Behavioral Activation and Attention Training on depression, well-being and other processes involved in depression as rumination. A multiple baseline design is followed with multiple idiographic assessments, in addition to a pre-post and follow-up standardized assessment design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 10, 2021

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 6, 2020

Last Update Submit

March 8, 2021

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (36)

  • Depressive symptomatology

    The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks. The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).

    up to 72 hours before treatment

  • Depressive symptomatology

    The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).

    up to 72 hours after treatment

  • Depressive symptomatology

    The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).

    Two weeks after treatment

  • Depressive symptomatology

    The Beck depression inventory- second edition (BDI-II) is a 21-item scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome)

    Three months after treatment

  • Activation

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)

    up to 72 hours before treatment

  • Activation

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome).

    up to 72 hours after treatment

  • Activation

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)

    Two weeks after treatment

  • Activation

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)

    Three months after treatment

  • Avoidance

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).

    up to 72 hours before treatment

  • Avoidance

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).

    up to 72 hours after treatment

  • Avoidance

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).

    Two weeks after treatment

  • Avoidance

    The Behavioral Activation for Depression Scale (BADS) is a 25-item scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).

    Three months after treatment

  • Social and Work Impairments

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)

    up to 72 hours before treatment

  • Social and Work Impairments

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)

    up to 72 hours after treatment

  • Social and Work Impairments

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)

    Two weeks after treatment

  • Social and Work Impairments

    The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)

    Three months after treatment

  • Mental Rumination

    The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).

    up to 72 hours before treatment

  • Mental Rumination

    The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).

    up to 72 hours after treatment

  • Mental Rumination

    The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).

    Two weeks after treatment

  • Mental Rumination

    The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).

    Three months after treatment

  • Well-being

    The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).

    up to 72 hours before treatment

  • Well-being

    The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).

    up to 72 hours after treatment

  • Well-being

    The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).

    Two weeks after treatment

  • Well-being

    The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).

    Three months after treatment

  • Anhedonia

    The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).

    up to 72 hours before treatment

  • Anhedonia

    The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).

    up to 72 hours after treatment

  • Anhedonia

    The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).

    Two weeks after treatment

  • Anhedonia

    The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).

    Three months after treatment

  • Cognitive control.

    A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).

    up to 72 hours before treatment

  • Cognitive control.

    A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).

    up to 72 hours after treatment

  • Cognitive control.

    A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).

    Two weeks after treatment

  • Cognitive control.

    A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).

    Three months after treatment

  • Attention Style Questionnaire

    The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.

    up to 72 hours before treatment

  • Attention Style Questionnaire

    The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.

    up to 72 hours after treatment

  • Attention Style Questionnaire

    The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.

    Two weeks after treatment

  • Attention Style Questionnaire

    The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.

    Three months after treatment

Secondary Outcomes (14)

  • Multiple measures of Activation

    everyday through study completion (an average of 7 to 9 weeks)

  • Multiple measures of reward motivation

    everyday through study completion (an average of 7 to 9 weeks)

  • Multiple measures of Avoidance

    everyday through study completion (an average of 7 to 9 weeks)

  • Multiple measures of focus of attention

    everyday through study completion (an average of 7 to 9 weeks)

  • Multiple measures of awareness

    everyday through study completion (an average of 7 to 9 weeks)

  • +9 more secondary outcomes

Study Arms (3)

Simultaneous interventions

EXPERIMENTAL

In this condition, both interventions are proposed simultaneously. Condition 1 is spread over 5 weeks with 5 weekly laboratory sessions of 2-hours (one hour of BATD and one hour of ATT separated by a break). A 30-minutes ATT sessions at home were prescribed between sessions for a total of 5 laboratory ATT sessions and 5 at home ATT sessions.

Behavioral: Behavioral Activation treatment with Attention Training Technique

Sequential interventions

EXPERIMENTAL

In this condition, the interventions are introduced sequentially. Condition 2 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 4 with of one hour of ATT followed by one hour of BATD separated by a break). A six 30-minutes ATT sessions were prescribed between the first 4 sessions of ATT for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.

Behavioral: Behavioral Activation treatment with Attention Training Technique

Sequential interventions in reverse order

EXPERIMENTAL

In this condition, the interventions are introduced sequentially in the reverse order than the condition 2. Condition 3 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 5 with of one hour of BATD followed by one hour of ATT separated by a break). A six 30-minutes ATT sessions were prescribed between the 4 last sessions for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.

Behavioral: Behavioral Activation treatment with Attention Training Technique

Interventions

Behavioral Activation treatment with Attention Training TechniqueBEHAVIORAL

The BATD includes the development of a shared formulation, psychoeducation, self-monitoring of daily activities, identifying "depressed behaviours", developing alternative goal orientated behaviours, scheduling of valued activities, and problem solving around difficulties implementing scheduled activities. Wells's Attention Training is a task designed to train selective attention to specific information by training individuals to attend to multiple auditory external sources. In addition to auditory exercices, the ATT sessions included psychoeducation, discussion around rumination (e.g. controllability, usefulness), self-report evaluation of self-focused before and after the auditory exercices, and transfer to everyday life.

Sequential interventionsSequential interventions in reverse orderSimultaneous interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good understanding of French,
  • at least a medium level of depressive symptoms
  • report the presence of abstract rumination that generates negative mood.

You may not qualify if:

  • Having a history of psychotic disorder
  • Having a history of Bipolar disorder,
  • Having a history of severe brain trauma or epilepsy
  • with a moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms
  • with an organic illness (e.g. cancer),
  • with a concurrent additional psychotherapy,
  • with acute suicidal ideation,
  • with evidence of a significant change in medication within one month prior to baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liège University

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Sylvie Blairy

    University of Liege

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
A blinding procedure was used for the pre-post evaluations: interviews were recorded and each video or sound recording was evaluated at the end of the study by one (or two) independent evaluator who was unaware of the recordings' assessment time.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 20, 2020

Study Start

October 20, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 10, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Data and analyses will be available from an online repository or from the principal investigator

Locations

BE(1)