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Effectiveness of a Personalized Inpatient Program for Persistent Depressive Disorder (PePsy)

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ClinicalTrials.gov Identifier: NCT03616665
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Schön Klinik Bad Arolsen
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:
The major objective of this randomized controlled study is to compare a new conceptualized personalized concept of Cognitive Behavioral Analysis System of Psychotherapy (CBASPersonalized) with a six-week waiting-list control (WLC) group and a version of Cognitive Behavioral Therapy (CBIntegrative) in the treatment of patients with persistent depressive disorder (PDD), childhood maltreatment, and treatment-resistance. Both active groups will be offered as treatment-phase programs (six-week inpatient-treatment and optional six-week blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting. This study addresses the primary research question: Is the intensive six-week inpatient CBASPersonalized treatment more effective than a six-week WLC in a clinical sample of PDD patients? In addition, CBASPersonalized will be compared with CBIntegrative investigating differential indication by moderator, mediator, and process analyses.

Condition or disease Intervention/treatment Phase
Persistent Depressive Disorder Behavioral: CBASPersonalized Behavioral: CBIntegrative Not Applicable

Detailed Description:

Background: Persistent depressive disorder (PDD) is a prevalent disabling disorder. Given its high degree of treatment-resistance (TR), comorbidity, and suicidality, this patient group constitutes a massive health problem. The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) was specifically developed for the outpatient treatment of PDD showing superiority to active control groups in some studies, yet not to the 'gold-standard' Cognitive Behavioral Therapy (CBT). In addition, non-remission and relapse rates of CBASP are relatively high, which might be caused by the fact that within the original CBASP-concept the frequent comorbid disorders are not sufficiently addressed. Thus, an optimized personalized CBASP-concept (CBASPersonalized) was established including the interpersonal CBASP-strategies while adding evidence-based intrapersonal strategies being tailored to the specific comorbid problems. In this study, the investigators will compare CBASPersonalized with I) a six-week waiting-list control (WLC) and II) CBT integrating strategies from the Acceptance and Commitment Therapy (CBIntegrative). Both active groups will be offered as treatment-phase programs (six-week inpatient-treatment and optional six-week blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting.

Methods: In the proposed prospective, mono-site, evaluator-blinded, randomized-controlled study, 192 PDD patients with childhood maltreatment and TR will be included. The study addresses the primary research question: Is the six-week inpatient CBASPersonalized-treatment more effective than a six-week WLC in PDD? It is hypothesized that six weeks after randomization, CBASPersonalized will significantly outperform WLC concerning reduction in depressive symptomatology (according to the 24-item version of the Hamilton Rating Scale of Depression, HRSD). In addition, the investigators will compare CBASPersonalized with CBIntegrative investigating differential indication by moderator, mediator, and process analyses. Primary and secondary outcome will be analyzed using analysis of covariance (ANCOVA) controlling for pre-treatment scores. Moderator, mediator, and process analyses will be performed using multiple regression and linear mixed models. A follow-up survey 6 months after end of treatment will provide important results on long-term treatment outcome.

Discussion: The results of this study may have the potential to alleviate the burden of this serious and cost-intensive disease while improving public health. In addition, moderator and mediator analyses may guide personalized treatment and enable therapists to address psychotherapeutic needs of PDD patients more specifically.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the proposed prospective, mono-site, evaluator-blinded, randomized-controlled study, 192 PDD patients will be included. The study addresses the primary research question: Is the six-week inpatient CBASPersonalized-treatment more effective than a six-week WLC in PDD? It is hypothesized that six weeks after randomization, CBASPersonalized will significantly outperform WLC concerning reduction in depressive symptomatology. In addition, CBASPersonalized will be compared with CBIntegrative investigating differential indication by moderator, mediator, and process analyses. A follow-up survey six months after end of treatment will provide important results on long-term treatment outcome.
Masking: Single (Outcomes Assessor)
Masking Description: Due to the nature of interventions, masking or blinding of patients/therapists is impossible, but all assessments and data analysis will be blinded to treatment allocation. Measures to insure blinding will include locating the raters separately from the study wards, instructing patients not to mention information that could reveal their allocation, and providing back-up raters in case of unintentional unblinding. All blinded observers will be trained in all instruments. The trial statistician will be blinded to the allocated treatments during the analysis of the primary outcome. Strict concealment of randomization will be guaranteed to exclude selection bias. Since randomization of therapists is impossible, demographic and professional characteristics of therapists will be assessed.
Primary Purpose: Treatment
Official Title: Effectiveness of a Personalized Inpatient Program Tailored for Persistent Depressive Disorder With Comorbidity: Personalized Cognitive Behavioral Analysis System of Psychotherapy vs. Integrative Cognitive Behavioral Therapy vs. Waiting List
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBASPersonalized
Within the psychotherapy CBASPersonalized, the original specific six interpersonal CBASP strategies are augmented with intrapersonal evidence-based strategies. According to the frequently diagnosed comorbid disorders of PDD the following modules have been added: a) treatment of anxiety disorders and treatment of traumatic experiences, b) regulating intensive emotions, c) coping with resistant problems like pain, and d) relapse prevention. In addition, therapists adjust their strategies and therapeutic relationship according to the impairment in personality functioning and maladaptive personality traits of the patient.
Behavioral: CBASPersonalized

Patients will receive the 6 week inpatient CBASPersonalized program (see above). In addition, algorithm-based pharmacotherapy in compliance with current national and international guidelines for depression treatment and according to clinical expert supervision. Of note, the intake of the medication is documented and taken into account in the analyses.

After after completion of the six-week inpatient treatment, patients will be offered the six-week blended-online-aftercare CBASPersonalized@home.

The amount of psychotherapeutic contact (dosage) will be balanced between the two active conditions.

Other Name: Drug

No Intervention: Waiting List Control (WLC)
Patients being randomized to the waiting list control (WLC) group have to wait six weeks before start of inpatient treatment. During this waiting period, the study-patients could continue their current treatments (naturalistic waiting period) which will be monitored.
Active Comparator: CBIntegrative
Patients assigned to this group receive the established and evidence-based psychotherapy cognitive behavioral therapy (CBT) whereas strategies of Acceptance and Commitment Therapy (ACT) are integrated. Basic CBT techniques will be applied in this group (e.g. psychoeducation, behavior analyses, behavioral activation, cognitive strategies, exposure sessions). Further, therapists are allowed to apply social competence training and euthymic techniques, self-management, relaxation techniques, and biofeedback. In addition, techniques from ACT will be integrated. Therapists are explicitly instructed not to use the original six interpersonal CBASP techniques or methods from schema therapy.
Behavioral: CBIntegrative

Patients will receive the inpatient CBIntegrative program (see above). In addition, algorithm-based pharmacotherapy in compliance with current national and international guidelines for depression treatment and according to clinical expert supervision. Of note, the intake of the medication is documented and taken into account in the analyses.

After after completion of the six-week inpatient treatment, patients will be offered the six-week blended-online-aftercare CBIntegrative@home. The amount of psychotherapeutic contact (dosage) will be balanced between the two active conditions.

Other Name: Drug




Primary Outcome Measures :
  1. Hamilton Rating Scale of Depression, 24-item version (HRSD-24) [ Time Frame: The primary outcome is given by the post value (week six: end of inpatient treatment and end of the waiting period in the WLC) in the HRSD24. ]
    The HRSD-24 is a semi-structured interview which is used to measure the severity of all symptom domains of depression as described by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) over a period of the last 7 days. It shows good psychometric properties. The HRSD-24 will be conducted by blind study raters at every time point. Raters evaluate symptom severity on a scale from 0 to 2 or 0 - 3 or 0 - 4 for each item, with higher number indicating higher symptom severity. The total score ranges from 0 to 75 with higher values indicating higher depression severity.


Secondary Outcome Measures :
  1. Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline, 2, 4, 6, 13, and 37 weeks after study start ]
    Self-report instrument to assess the severity of depression on 21 items, each symptom represents one item with responses from 0 (symptom absent) to 4 (symptom present). The total score ranges from 0 to 63 with higher values indicating more severe depressive symptoms.

  2. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, 2, 4, 6, 13, and 37 weeks after study start ]
    Observer-report instrument to assess the severity of depression (symptom areas: apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts) on a 7-point Likert scale with 6 representing highest severity. In the applied MADRS+ version, three items assessing helplessness, hopelessness and worthlessness are added. Hence, the total score of MADRS+ ranges from 0 - 71 with higher values indicating more severe depression.

  3. Brief Symptom Inventory (BSI) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    Self-report questionnaire to assess general psychopathological symptom severity in nine different symptom dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, general severity score) on a scale from 0 to 4 with 4 representing more severe symptoms. A global indicator is the General Severity Index (GSI) which will be used as a total score here. The GSI is given by the mean of all subscales and ranges from 0 (low general symptom severity) to 4 (high severity).

  4. Patient Health Questionnaire (PHQ) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    Self-report questionnaire for the assessment of various mental health conditions (factors are somatic, anxiety and depression symptom scales), responses are given on a scale from 0 to 2 (with 2 representing higher symptom severity)

  5. Personality Inventory of DSM-5 (PID-5) [ Time Frame: Baseline, 2, 4, 6, 13, and 37 weeks after study start ]
    Self-report questionnaire to assess maladaptive personality traits based on the Alternative DSM-5 Model for Personality Disorders. On a four-point response scale, several personality traits are assessed (submissiveness, restricted affectivity, separation insecurity, anxiousness, emotional lability, hostility, perseveration, suspiciousness, depressivity, withdrawal, intimacy avoidance, anhedonia, manipulativeness, deceitfulness, callousness, attention seeking, grandiosity, irresponsibility, impulsivity, distractability, rigid perfectionism, risk taking, eccentricity, perceptual dysregulation, unusual beliefs or experiences)

  6. Inventory of Personality Organization (IPO-16) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    Self-report measure for the assessment of personality dysfunction in three domains (identity, defense, reality-testing)

  7. Borderline Symptom List (BSL) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    Self-report measure to quantify borderline symptomatology (including sudden changes in mood, self-harming behavior, impulsivity)

  8. State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    Self-report measure to state anxiety, e.g. anxiety about a specific event, and trait anxiety, i.e. anxiety as a personal characteristic. It consists of 40 questions - 20 items assess state anxiety, the 20 other items assess trait anxiety. All responses are given on a 4-point Likert scale. Scores range from 20 to 80, with higher scores correlating with higher anxiety.

  9. revised Impact of Event Scale (IES-R) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report of post-traumatic stress symptoms with the three subdomains intrusions, avoidance and over-arousal; a scoring scheme with intervals of 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) is used to reflect frequency of symptoms over the past week. Subscales are analyzed by summing up all responses of items that belong to one subscale. Intrusion and hyperarousal range between 0 - 35 and avoidance ranges between 0 - 40, with higher values indicating more severe intrusion/ hyperarousal/ avoidance.

  10. Screening for Somatoform Symptoms - 7 (SOMS-7) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess organically unexplained physical symptoms for the past seven days. The SOMS is available for men (48 items) and women (52 items). Responses are given on a 5-point Likert scale (from 0= not at all to 4= a lot) and indicate how much the patient felt disabled by a specific symptom during the past week. For every response >2 on the 5-point scale, one point is added to a sum score. Higher values indicate higher risk for a somatoform disorder according to DSM-IV or ICD-10

  11. Social Support Questionnaire F-SozU [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess perceived social support on the four scales emotional and practical support, social integration, and social stress. Additional scales are reciprocity, availability of a trusted person, satisfaction with social support. Contains 54 items; responses are given on a 5-point Likert scale. Patients indicate their level of agreement with a presented statement from 0 (totally disagreed) to 4 (totally agreed). The total range is from 0 to 216 with higher values representing higher perceived and received social support.

  12. Depressive Expectations Scale (DES) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess intensity of dysfunctional expectations (regarding social rejection/ support, mood regulation and the ability to perform). The DES consists of 25 items. Responses are given on a 5-point Likert-scale where patients express their agreement with a given statement (1= I don't agree to 5= I agree). The total score varies between 0 and 125 with higher values indicating higher intensity of dysfunctional expectations.

  13. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess the flexibility and adaptiveness of emotion regulation. The DERS consists of 36 items. Responses are given on a 5-point Likert-scale where patients indicate how often the following statements apply to them (1= almost never (0-10%) to 5= almost always (91-100%). The total score varies between 0 and 180 with higher scores suggesting greater problems with emotion regulation.

  14. Interpersonal Reactivity Index (IRI) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report measure to assess individual differences in empathy on 4 scales: FS= fantasy scale, PT=perspective taking, EC=empathy concern, PD=personal distress. Response format is a 4-point Likert-type scale ranging from 0 (does not describe me at all) to 4 (describes me very well). There are 28 items in the IRI and on the 4 subscales, maximum scores of 28 can be achieved. Higher values reflect higher fantasy/ perspective taking/ empathic concern or personal distress, respectively.

  15. revised Adult Attachment Scale (AAS-R) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess individual's attachment style on the subscales closeness, trust and anxiety; on a scale from 1 (not at all true) to 5 (very true). There are 15 items in total with 5 belonging to each subscale. Higher values reflect higher comfort with closeness or depending on others or concern about abandonment.

  16. Toronto-Alexithymia-Scale (TAS-20) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess alexithymia, i.e. difficulty identifying feelings, difficulty describing feelings of others, externally oriented thinking on a 5-point Likert scale. The total score ranges between 0 and 100 with higher values indicating higher levels of alexithymia.

  17. Self-Compassion Scale-Short Form (SCS-SF) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess six components of self-compassion (self-kindness, self-judgement, common humanity, isolation, mindfulness, over-identification). Response format ist a 5-point Likert-type scale ranging from 1 (almost never) to 5 (almost always). Total scores can range between 0 and 60 with higher values representing higher levels of self-compassion.

  18. Rosenberg's general self-esteem scale [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess self-esteem (factors are self-confidence and self-depreciation) on a 4-point scale from 1 (strongly agree) to 4 (strongly disagree). There are 10 items in the RSE and the total score ranges from 0 to 40, with higher values indicating higher self-esteem.

  19. FIMA [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess an individual's healthcare utilization. It contains 28 items. The response format varies per item (yes/ no items, frequency items (X times per week). It assesses need for assistance by nurses or family members, medication use, hospital stays, living situation, and more.

  20. General Self-efficacy Scale (SEW) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-report to assess general self-efficacy beliefs. The SEW consists of 10 items and responses are given on a scale from 1 (not true) to 4 (exactly true). The total score ranges from 0 to 40 with higher values representing higher levels of self-efficacy.

  21. Impact Message Inventory (IMI-R) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    observer-rated questionnaire designed to measure distinctive internal reactions, referred to as impact messages, that interactants experience to the full range of interpersonal behaviours indexed along the circumplex of the interpersonal circle with the 2 dimensions dominance-submissiveness and friendliness-hostility. Messages are rated on a scale from 0 (not at all) to 4 (very much). The total score of each subscale is considered for analysis.

  22. Global Assessment of Functioning (GAF) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    observer-rated questionnaire to measure functioning in 9 descriptors (work, law, social (family and friends), judgement, thinking, mood, anxiety, hallucinations, suicidal ideation). Each descriptor has a 9-point range from 0 (most severe) to 90 (least severe)

  23. Measure of Disorders of Capacity as defined by the International Classification of Functioning (MINI-ICF) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    observer-rated questionnaire to measure quality of life and functioning, framed as skill deficits in 12 areas (e.g. skill to adapt to rules and routines, professional and non-professional skills, assertiveness, endurance etc.) Skill deficits are assessed using a response scale from 0 (no skill deficits) to 4 (complete absence of skill)

  24. World Health Organization Quality of Life Instruments (WHO-QOL-BREF) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to measure quality of life (domains of quality of life are physical, psychological, social relationships and environment). It contains 26 items with four types of 5-point Likert scales (0 to 4), reflecting intensity, capacity, frequency or evaluation, respectively. Higher values indicate higher intensity, frequency etc.

  25. Health-related quality of life (EQ-5D-5L) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to measure health-related quality of life. Health is assessed using 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression. For each dimensions, participants can select one option out of 5 that describes them best.

  26. Psychological Well-Being Scale (P-WBS) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to assess well-being. The P-WBS consists of 42 items which form 6 subscales (autonomy, environmental mastery, personal growth, positive relations, purpose in life and self-acceptance). The total score is from 0 to 252, with higher values indicating higher psychological well-being.

  27. Euthymia Scale (ES) [ Time Frame: Baseline, 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to assess euthymia. It contains 10 items which assess factors of general mood, energy and coping with stressors. Responses are given by selecting (True/ False) for a specific statement. The total range of the ES is from 0 to 10 with 10 indicating higher prevalence of euthymia.

  28. Working Alliance Inventory (WAI-SR) [ Time Frame: 2, 4, 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to assess the therapeutic relationship on three subscales (12 items each): a) Goals: Agreement about the goals of the therapy; b) Tasks: Agreement about the tasks of the therapy, c) Bonds: Bond between therapist and client. Responses are given on a 7-point Likert scale reflecting agreement with a specific statement (1= totally disagree, 7= totally agree). Sum scores are analysed per all 3 subscales where higher values indicate higher satisfaction with the therapeutic relationship (0 to 72).

  29. Job Descriptive Questionnaire JDQ [ Time Frame: 16, 13 and 37 weeks after study start ]
    This instrument measures satisfaction with job-related aspects such as colleagues, supervisors, tasks, conditions, administration and organization, opportunities for personal development and wage. Responses are given on a Likert scale which ranges from 1 (not at all satisfied) to 6 (very satisfied). The total score ranges from 7 to 42 with higher values indicating higher satisfaction.

  30. Job Motivation Questionnaire [ Time Frame: 16, 13 and 37 weeks after study start ]
    assesses positive and resigned job satisfaction on 7 items. Responses are given on a 7-point Likert scale from 1 (almost never) to 7 (almost always). Positive and resigned job satisfaction can range between a minimum of 7 and a maximum of 28, with higher values indicating higher job satisfaction.

  31. Inventory for the Assessment of Negative Effects of Psychotherapy (INEP) [ Time Frame: 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to assess negative effects of psychotherapy. It contains the subscales 1) aversive intrapersonal changes related to therapy, 2) social relationships, 3) work-related aversive changes, 4) therapeutic misconduct, 5) stigmatization. It contains 21 items. Response format is a 7-step bipolar Likert-scale from -3 = definitely a negative effect, 0 = unchanged, +3 = definitely a positive effect

  32. Adverse Effects of Inpatient Psychotherapy (ADEFIP) [ Time Frame: 6, 13, and 37 weeks after study start ]
    self-rated questionnaire to assess negative effects of inpatient psychotherapy. Subscales are 1) worsening of symptoms, 2) interpersonal conflicts in the clinic context, 3) significant aversive changes in 5 psychosocial areas (incl. partner, friendships, work, housing situation, financial situation). It contains 13 items (asking for occurence: yes/ no) that are rated regarding the impact on the patient's life on a scale from 1 (no impact) to 5 (high impact)

  33. Longitudinal Follow-Up Evaluation Interview (LIFE) [ Time Frame: 37 weeks after study start (6 months after end of treatment) ]
    which is an integrated system for assessing the longitudinal course of psychiatric disorders to collect detailed psychosocial, psychopathologic, and treatment information for a six-month follow-up interval


Other Outcome Measures:
  1. Moderator variable: Childhood Trauma Questionnaire (CTQ) [ Time Frame: baseline ]
    It will be investigated whether childhood maltreatment differentially moderate effectiveness of treatments. Thus, childhood maltreatment will be assessed using the longer version of the Childhood Trauma Questionnaire (CTQ) with its five subscales: emotional neglect, emotional abuse, physical neglect, physical abuse and sexual abuse. These are rated on a scale from 1 to 5, with higher values indicating higher frequency of abuse. The CTQ consists of 40 items. 34 items assess the frequency of different types of childhood trauma on a scale from 1 (not at all) to 5 (very often). 6 more items are used to assess the age (or age-span) where the trauma has occurred.

  2. Mediator variable: Inventory of Interpersonal Problems (IIP) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 13, and 37 weeks after study start ]
    It will be examined whether the effectiveness of CBASPersonalized and CBIntegrative (compared to WLC) can be explained by an improvement of interpersonal problems in CBASP. The IIP is a self-rated questionnaire to assess a variety of interpersonal problems.

  3. Mediator variable: Interpersonal Adjective List (IAL) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 13, and 37 weeks after study start ]
    It will be investigated whether the effectiveness of CBASPersonalized and CBIntegrative (compared to WLC) can be explained by an improvement of interpersonal problems in CBASP. The IAL is a self-rated questionnaire to assess perceived interpersonal adjectives.

  4. Mediator variable: Dysfunctional Attitude Scale (DAS) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 13, and 37 weeks after study start ]
    It will be examined whether the effectiveness of CBASPersonalized and CBIntegrative (compared to WLC) can be explained by a decrease of dysfunctional attitudes and an increase in value-driven activities in CBIntegrative. The DAS is a self-report questionnaire to assess dysfunctional attitudes. It contains 40 items that assess depressogenic attitudes (need for approval, perfectionism, avoidance of risk/ need for success, need to impress others, need for approval, need to control feelings). There are 7 response categories (7= totally agree, 1= totally disagree). A total value of 280 can be achieved with higher values representing higher prevalence of dysfunctional attitudes.

  5. Mediator variable: Behavioral Activation of Depression Scale (BADS) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 13, and 37 weeks after study start ]
    It will be investigated whether the effectiveness of CBASPersonalized and CBIntegrative (compared to WLC) can be explained by a decrease of dysfunctional attitudes and an increase in value-driven activities in CBIntegrative. The BADS is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Areas of interest are 1) sleeping and staying in bed, 2) activity, 3) avoidance, 4) rumination, 5) social problems, 6) work and school problems, 7) coping skills, 8) mood dependent behavior, 9) awareness and identification problems. Responses are given on a 7-point scale (from 0= not at all to 6 = completely)

  6. Process variable via the App 'Moodpath' [ Time Frame: 3 times a day (morning, midday, evening) ]
    Questions covering all symptom areas according to DSM-5; questions are first answered by a dichotomous input; if the existence of a symptom is affirmed, the rating follows the current burden of the symptom on a 4-point scale; in addition, the current mood is registered on a 5-point smiley scale; finally, the patient can indicate his experienced feelings and situations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of persistent depressive disorder (PDD) according to DSM-5
  • Experiences of childhood maltreatment (>Cut-off criteria in one of 5 scales of the Childhood Trauma Screener (CTS))
  • Treatment-resistance (defined as unsuccessful completion of at least one professionally administered and evidence-based psychotherapy within the current episode)
  • Sufficient German language proficiency
  • Have read and signed an informed consent form

Exclusion Criteria:

  • Life-time diagnosis of an schizophrenia or schizophrenic spectrum disorder according to DSM-IV
  • Life-time diagnosis of a schizoid, schizotypal or antisocial personality disorder according to DSM-IV
  • Substance abuse disorder (with < six months abstinence) according to DSM-IV
  • Diagnosis of anorexia nervosa (with BMI < 16) according to DSM-IV
  • Acute suicidality at first assessment time point (patients will be referred to a psychiatric clinic for further care)
  • Private health insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616665


Contacts
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Contact: Eva-Lotta Brakemeier, Prof. Dr. +491711278600 eva-lotta.brakemeier@uni-marburg.de
Contact: Vsevolod Silov, Dr. +49 5691 6238-3043 VSilov@Schoen-Kliniken.de

Sponsors and Collaborators
Philipps University Marburg Medical Center
Schön Klinik Bad Arolsen
Investigators
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Principal Investigator: Eva-Lotta Brakemeier, Prof. Dr. Philipps Universität Marburg

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03616665     History of Changes
Other Study ID Numbers: 2018_14k
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data will be shared with researchers providing a clinical relevant and methodological sound proposal.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: These above mentioned proposals should be submitted within 48 months following first publication of the main results of this trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philipps University Marburg Medical Center:
persistent depressive disorder
psychotherapy
cognitive behavioral therapy
inpatient treatment
childhood maltreatment
treatment-resistance
randomized controlled trial
clinical effectiveness
personalized psychotherapy
comorbidity
cognitive behavioral analysis system of psychotherapy

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms