In clinical settings, the ART program was evaluated in samples of inpatients. A randomly selected subgroup of patients meeting criteria for any mental disorder was offered to replace part of their regular cognitive behavioral therapy CBT with an abbreviated version of ART. Patients in the ART condition displayed significantly greater increases in adaptive ER, greater decreases in MDD and negative affect, and greater increases in positive affect than patients receiving only conventional CBT [ 19 ]. In a prospective randomized controlled trial on individuals meeting criteria for MDD [ 8 ], patients allocated to a condition in which some CBT sessions were replaced by a short version of ART also showed greater gains in the acquisition of health-relevant ER skills modification, acceptance and tolerance of undesired emotions as well as effective self-support and greater reductions of depressive symptoms when compared to patients in the regular CBT condition.
Despite these encouraging findings, existing research on ART is limited by a number of factors. First, previous clinical studies used a short version of ART. Second, ART has not yet been compared with an untreated control condition or with a condition that accounts for unspecific therapeutic factors. Third, it has not yet been investigated whether ART would augment the effects of other empirically-evidenced treatments for MDD possibly because enhanced ER skills might allow patients to engage more intensely in the therapeutic process, [ 31 ].
Finally, in previous study outcomes the effectiveness of ART was exclusively assessed through self-report measures and only at pre- and post-treatment. In an attempt to clarify whether experimentally enhancing general ER skills reduces depressive symptom severity and whether fostering adaptive ER skills enhances the outcome of subsequent individual CBT for depression iCBT-D , we will evaluate the efficacy of ART in a prospective randomized controlled trial.
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Stand-alone and augmenting effects of ART will be compared with a waitlist control condition and a condition controlling for active ingredients common to most empirically evidenced treatments. Primary depressive symptom severity and secondary outcomes will be assessed at intake and 10 points over the course of the study. Measurements will include self-reports, observer ratings, ecological momentary assessments EMA [ 32 ] and will include experimental investigations and the analysis of hair steroids in subsamples.
The study is designed as a prospective randomized controlled trial in an outpatient setting. Following three sessions with their individual therapists, enrolled patients will be assigned to the ART group, an active common factor-based treatment control condition CFT-C or a waitlist control group using a computerized randomization tool randomisation. Group therapies will be provided for 18 hours over the course of 8 weeks.
Participants in the waiting condition will be offered to participate in ART after completion of the study. Following the group and a 4-week follow-up waiting phase, all participants will receive 16 hours of standardized and manualized iCBT for depression. Individual treatment will be continued beyond the study if necessary. The study has been approved by the ethical committee of the German Psychological Society and of the University of Marburg. It was registered with ClinicalTrials. Overview of design and assessments.
Inclusion criteria will include MDD as the primary diagnosis, age 18 or above, and sufficient German language skills. Exclusion criteria will include high risk of suicide, indication of substantial secondary gain e. Other comorbid disorders, including personality disorders, will be accepted to increase validity of the study. Study participants will be recruited at outpatient treatment centers in Marburg, Mainz, and Kassel.
Potential participants will be screened on eligibility and provided with study information on the phone. Patients meeting inclusion criteria and having provided informed consent will be included in the study. Recruitment will be conducted consecutively, that is, 10 to 15 individuals at a time will be enrolled in each cohort.
ART was developed as an adjunctive or stand-alone transdiagnostic and group-based intervention, explicitly focusing on an increase in adaptive ER in individuals who meet criteria for mental disorders or are at-risk for developing mental health problems. To foster effective ER, ART utilizes elements from various psychotherapeutic approaches as cognitive behavioral therapy [ 33 ], dialectical behavioral therapy [ 27 ] emotion focused therapy [ 29 ], mindfulness-based interventions [ 34 ], neuro-psychotherapeutic translational approaches [ 35 ], compassion-based therapy [ 36 , 37 ], problem solving therapies [ 38 ], and strength-focused interventions [ 39 , 40 ].
At the beginning of the training, participants are provided with information on emotions including biological and psychological origins, functions, risks, and benefits of emotional reactions. Individuals are taught skills to break these cycles and enhance effective ER. These skills include muscle and breathing relaxation, nonjudgmental emotional awareness, acceptance, and tolerance, compassionate self-support, the identification of causes of emotional reactions, and modification of affective states.
In the building of ER skills, special emphasis is placed on the importance of regular training. CFT-C was established as an active control group to account for unspecific change mechanisms of psychotherapy i. Following the identification of personally relevant goals and associated motives, acceptance is targeted for goals that cannot or no longer can be achieved; problem solving processes are initiated for achievable goals.
Problem solving steps that are taught include the identification and a detailed description of problems and relevant situational features, the definition of goals, the development, evaluation, selection, and processing of solutions, and processes of success monitoring and reinitiating the problem solving or acceptance processes when necessary. Individual therapy will cover a 4-month period with 16 weekly min sessions in total.
Treatment will follow a manualized protocol based on procedures developed by Hautzinger [ 41 ], which includes psycho-education on MDD, behavioral activation, cognitive restructuring, social skills training, stress reduction, and relapse prevention. Participants will be assessed at intake and at 10 points over the course of the study: before T1 , during T , and after the group-based phase T5 , after the subsequent 4-week follow-up waiting phase before individual CBT starts T6 , during T , and post the first four months of individual CBT T Measures will include self-report questionnaires, interviews, observer-based ratings, EMA, experimental investigations, and analyses of hair steroids.
Questionnaires will all be provided in paper pencil format and in German language.
Participants will be provided with iPhones for the EMA. Over 7-day periods, time-contingent assessments will be taken 3 times per day and one hour after each of the three assessments.
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Participants will be given the chance to supplement time-contingent assessments with event-contingent assessments whenever they feel significantly distressed. Enrolled patients will also be asked to participate in an experimental investigation of ER skills and to provide hair probes. Participants will be compensated 50 Euros for the burden associated with study diagnostics, and an additional 20 Euros will be provided for participating in the experiment or providing hair probes.
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Higher sum scores indicate greater symptom severity. The cut-off points of 10, 19, 27, and 35 represent thresholds for mild, moderate, severe, and very severe depression, respectively. The HRSD is sensitive to change and corresponds well with overall clinical ratings of severity [ 43 , 44 ]. The following socio-demographic data will be collected: age, gender, marital status, partnership, children, current living situation, educational level, occupation learned, occupation held, and immigration.
The List of Situational Stressors LSS will assess for potential cues of negative emotional reactions to 11 daily events. Individuals are asked to rate how often within the last week they experienced stressors such as arguments with a friend, romantic partner or family member interpersonal domain , high workload work-related , financial problems financial domain , and trouble with means of transport everyday stressors.
The scale has previously been used in a study on affective reactivity as a predictor of depressive symptoms [ 46 ]. The BDI II is a widely used item self-report measure of somatic, behavioral, emotional, and cognitive signs of depression. Good reliability and validity have previously been demonstrated [ 48 ]. The SPWB includes scales for autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Given that psychometric analyses of the SPWB have not always supported the proposed six factor structure [ 50 , 51 ], we will use the total score in this study. High internal consistency and test-retest reliability coefficients were reported in the original validation study [ 49 ]. Within a previous validation study [ 52 ], good internal consistency was revealed, and associations with related constructs such as anxiety, depression, and neuroticism were significant and in the expected directions.
On 4-point Likert scales, participants rate how often they experienced 50 different emotions in the past week.
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To obtain continuous information on comorbid symptom severity, a global severity index will be computed on all but the depression scales of the Brief Symptom Inventory BSI [ 53 ]. The BSI is a screening tool for psychological disturbance including depression, somatization, obsessive-compulsive symptoms, interpersonal sensitivity, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Adequate psychometric properties with very high internal consistency for the total score have previously been reported for the German scale [ 54 ].
The DASS is a item self-report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. For the English scale, good to excellent internal consistency scores were reported, and associations with other measures of depression, anxiety, and stress were within the high range [ 57 ]. Results from validation studies [ 20 ] indicate that both the total score and the subscales of the ERSQ have good internal consistencies and adequate retest-reliability.
Sound psychometric properties have previously been reported for this scale.
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The DERS assesses difficulties in emotional awareness, emotional acceptance, goal-directed behaviors and the application of effective ER strategies. The TMMS is a measure of emotional intelligence including the components of emotional attention, clarity, and mood repair. To control for potential confounds, we will assess general self-efficacy with a item, validated German scale Skala zur Allgemeinen Selbstwirksamkeitserwartung, ASE [ 62 ]. Perfectionism will be assessed by the Multidimensional Perfectionism Scale MPS [ 63 ], including 35 items on concerns about mistakes, personal standards, parental expectations, parental criticism, doubts about actions, and organization.
Adequate psychometric properties of these scales have been reported in the cited studies. Targeting the issue of cognitive distortion and to increase ecological validity, EMA will be implemented as a real-time assessment of ER, affective states, and affective changes. Additional questions will address location, activity, and interaction partners. To reduce self-report biases and to yield further information on causality, the effects of adaptive ER on positive and negative affect will be tested experimentally.
In laboratory settings, negative and positive affective states will be induced by music and self-related statements using the Velten [ 65 ] method. Participants will be provided with oral instructions of adaptive ER strategies i. Hair probes will be taken to gather data for biological features of MDD. Elevated levels of hair steroids i.
In the analyses of hair steroids, we will use liquid chromatography with linked tandem mass spectrometry. Targeted sample sizes are based on power calculations. The intended sample of individuals can be expected to provide sufficient power to detect small effects [ 67 ]. Data will be analyzed according to intent to treat and treatment completers principles.
The intent to treatment analyses will be the primary level of analyses. Mixed effect modeling will serve as the main approach in the analyses of study data and in the treatment of missing values. Slopes for the ART condition are hypothesized to be larger than those for the active or waitlist control groups, indicating the effectiveness of adaptive ER skills application enhancement and a decrease in depressive symptom severity by the ART program.