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.
Major depressive disorder (MDD) is one of the most prevalent mental disorders, as well as one of the leading causes of disability worldwide. Behavioral activation is an empirically validated treatment for depression associated with medium effect size. The rationale of behavioral activation is to increase activation and reduce avoidance in order to reduce depressive affects. In parallel, Attention Training Techniques (ATT) is also an empirically validated treatment for depression. The rationale of ATT is to attenuate the self-focused attention and increase flexible attentional control over information processing to reduce depressive affects. ATT could target specific cognitive factors that are not changed through traditional interventions, and might enhance treatment outcomes for clinical and subclinical depressed when used in adjunct to psychotherapy. Then, the use of ATT may be a promising avenue to increase effectiveness of behavioral activation treatment. The aims of the study are multiple. First, to measure the treatment feasibility and adherence of different treatment combinations and to measure it throughout the study. Second, to investigate the efficacy of Behavioral Activation Therapy for Depression combined with Attention Training sessions in subclinical and clinical depressed participants. Third, to investigate the mechanisms of change of both interventions. The design will follow an "A1-B-A2'" design. Daily ideographic measures will be collected during all phases. Phase A1 and A2 are non-interventional phases of baseline and follow-up period respectively. Participants are randomly allocated to baseline lengths of 7, 10 and 15 days. Phase B is the intervention phase ranging from 5 weeks to 7 weeks. Three conditions exist with participants randomly allocated to one of these conditions. The intervention is provided in individual once a week. The first condition is a combination of 5 weeks of behavioral activation treatment for depression (BATD) and Attention Training technique (ATT)(2 hours/week). The second condition is 3 weeks of ATT followed by 5 weeks of BATD (1 hour/week), and the third is 5 weeks of BATD followed by 3 weeks of ATT (1 hour/week). Nomothetic standardized measures were also collected at pre-treatment (T0), after treatment (T1), after two weeks (T2) and 3 months later (T3). The investigators hypothesized that the three proposed conditions will have an effect on the following target variables: activation, avoidance, reward motivation, self-focused attention, awareness as well as on transfer measures: depressive symptoms, rumination, anhedonia, well-being, social and work impairments, and cognitive control (2) changes in the target variables should preceded changes in the transfer measures (3) the therapeutic effects would be greater and faster when the treatments are combined than when they are offered sequentialy (i.e., in condition 1 versus conditions 2 and, (4) the therapeutic effect observed in Phase B was maintained in follow-up. Target measures were expected to change with the introduction of intervention in comparison to baseline phase. In Condition of combination, the investigators expected to observe in Phase B an enhancement of activation, awareness and reward motivation and a decrease in avoidance and self-focused attention in comparison to the baseline phase. In Condition 2 with ATT sessions followed by BA sessions, the investigators expected to observe a reduction of self-focus attention, and an enhancement of awareness with the introduction of ATT, and an enhancement of activation and reward motivation and a reduction of avoidance with the introduction of BA. In Condition 3 with BA sessions followed by ATT sessions, the investigators expected the opposite pattern of change with first an enhancement of activation and reward motivation and a reduction of avoidance with the introduction of BA in comparison to baseline and then a reduction of self-focus attention, and an enhancement of awareness with the introduction of ATT in comparison to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Liège University
Liège, Belgium
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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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).
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Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three months after treatment
Multiple measures of Activation
Activation level was collected daily at the end of the day in a booklet with the following item "I have been an active person and have accomplished the goals I set for myself." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of reward motivation
Reward motivation was collected daily at the end of the day in a booklet with the following item "I am looking forward to some upcoming events or activities" accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of Avoidance
Avoidance was collected daily at the end of the day in a booklet with the following item "Most of what I did was to escape from or avoid something unpleasant." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of focus of attention
Focus of attention was collected daily at the end of the day in a booklet with the following item "I focused my attention on myself rather than on my external environment." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of awareness
Awareness was collected daily at the end of the day in a booklet with the following item "I was aware of my thoughts, body sensations, emotions and feelings" accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of Rumination
Rumination was collected daily at the end of the day in a booklet with the following item ". I spent a long time thinking over and over about my problems." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple individual measures of depressive symptoms
Two items assessing depressive symptoms were selected by the participant based on a idiographic approach. For exemple : "I had difficulty to experience pleasure in what I did", "I felt tired", "I felt like I was being punished", "I had a hard time getting interested in anything", "I've been irritable", "I felt guilty", "I felt sad". Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple individual measures of functioning on disturbed area of life
Two items assessing disturbed functioning on area of life (e.g. social, professional, daily skills, hobbies, family, or relationships) were selected by the participant based on a idiographic approach. Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple individual measures of personal complaints not related to the intervention.
One item assessing personal complaints (e.g. impulsivity, assertiveness, sleep) was selected by the participant based on a idiographic approach. Personal complaints was collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Multiple measures of mood
Mood was collected daily at the end of the day in a booklet with items accompanied by a Visual Analogue Scale (ranging from left side : very negative to right side very positive).
Time frame: everyday through study completion (an average of 7 to 9 weeks)
Credibility and Expectancy
The Credibility and expectancy of treatment Questionnaire (CEQ) is a 6-items scale that assesses the therapy credibility who refers to the extent to which a treatment makes sense, is believable, convincing and logical, and the expectancy who refers to improvements that patients believe will occur with the intervention. Two subscales are identified: the Credibility and the Expectancy. Higher scores indicate better credibility and Expectancy from the patients (better outcome).
Time frame: Up to 72 hours after the beginning of interventions and through intervention completion (an average of 5 to 7 weeks).
Therapeutic alliance
The Helping Alliance Questionnaire (HAQ) is a 8-items scale that assesses client-reported quality of the therapeutic alliance. Higher score indicated higher client satisfaction in the therapeutic alliance (better outcome).
Time frame: Up to 72 hours after the beginning of interventions and through intervention completion (an average of 5 to 7 weeks).
Client Satisfaction
The Consumer Satisfaction Questionnaire (CSQ) is a 8-items scale that assesses client satisfaction with treatment. Higher score indicates greater satisfaction.
Time frame: up to 72 hours after treatment
Client adherence and satisfaction
This post intervention interview focused on satisfaction with the organization (i.e., size of the group, rhythm of progression, materials given, sessions' length, sessions' frequency, location, equipment), with the content (i.e., pertinence to everyday life, helpfulness of tools and compatibility with their expectations, identification, applicability, improvement, feedback) and with the therapists (i.e., motivation, communication skills, knowledge, adaptation abilities).
Time frame: up to 72 hours after treatment