A modular add-on approach for patients with comorbid depression and a history of childhood maltreatment
- Conditions
- F32.1F32.2F33.1F33.2Moderate depressive episodeSevere depressive episode without psychotic symptomsRecurrent depressive disorder, current episode moderateRecurrent depressive disorder, current episode severe without psychotic symptoms
- Registration Number
- DRKS00022093
- Lead Sponsor
- Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Effect sizes of psychotherapies currently stagnate at a low-to-moderate level. Personalizing psychotherapy by algorithm-based modular procedures promises improved outcomes, greater flexibility, and a better fit between research and practice. However, evidence for the feasibility and efficacy of modular-based psychotherapy, using a personalized treatment algorithm, is lacking. This proof-of-concept randomized controlled trial was conducted in 70 adult outpatients with a primary DSM-5 diagnosis of major depressive disorder, a score higher than 18 on the 24-item Hamilton Rating Scale for Depression (HRSD-24), at least one comorbid psychiatric diagnosis according to the Structured Clinical Interview for DSM-5 (SCID-5), a history of at least “moderate to severe” childhood maltreatment on at least one domain of the Childhood Trauma Questionnaire (CTQ), and exceeding the cut-off value on at least one of three measures of early trauma-related transdiagnostic mechanisms: the Rejection Sensitivity Questionnaire (RSQ), the Interpersonal Reactivity Index (IRI), and the Difficulties in Emotion Regulation Scale-16 (DERS-16). Patients were randomized to 20 sessions of either standard cognitive-behavioral therapy alone (CBT) or CBT plus transdiagnostic modules according to a mechanism-based treatment algorithm (MoBa), over 16 weeks. We aimed to assess the feasibility of MoBa, and to compare MoBa vs. CBT with respect to participants’ and therapists’ overall satisfaction and ratings of therapeutic alliance (using the Working Alliance Inventory - Short Revised, WAI-SR), efficacy, impact on early trauma-related transdiagnostic mechanisms, and safety. The primary outcome for efficacy was the HRSD-24 score at post-treatment. Secondary outcomes included, among others, the rate of response (defined as a reduction of the HRSD-24 score by at least 50% from baseline and a score <16 at post-treatment), the rate of remission (defined as a HRSD-24 score =8 at post-treatment), and improvements in early trauma-related mechanisms of social threat response, hyperarousal, and social processes/empathy. We found no difficulties in the selection of the transdiagnostic modules in the individual patients, applying the above-mentioned cut-offs, and in the implementation of MoBa. Both participants and therapists reported higher overall satisfaction and had higher WAI-SR ratings with MoBa than CBT. Both approaches led to major reductions of depressive symptoms at post-treatment, with a non-significant superiority of MoBa over CBT. Patients randomized to MoBa were nearly three times as likely to experience remission at the end of therapy (29.4% vs. 11.4%; odds ratio, OR = 3.2, 95% CI: 0.9-11.6). Among mechanism-based outcomes, MoBa patients showed a significantly higher post-treatment effect on social processes/empathy (p<0.05) compared to CBT patients, who presented an exacerbation on this domain at post-treatment. Substantially less adverse events were reported for MoBa compared to CBT. These results suggest the feasibility and acceptability of an algorithm-based modular psychotherapy complementing CBT in depressed patients with psychiatric comorbidities and early trauma. While initial evidence of efficacy was observed, potential clinical advantages and interindividual heterogeneity in treatment outcomes will have to be investigated in fully powered confirmation trials.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
episodic or persistent MDD or MDD superimposed on Dysthymia (Double Depression”) as the primary diagnosis (SCID I); a score of > 18 on the Hamilton Rating Scale for Depression (HRSD-24); history of childhood maltreatment (at least moderate to severe in one or more of the five categories: emotional neglect or abuse, physical neglect or abuse, sexual abuse); comorbidity on axis I or II (SCID I and II) except for those described in the exclusion criteria; exceeding the cut-off” value (defined as 1 standard deviation from the population mean) of at least one of the following measures: 1) Rejection Sensitivity Questionnaire (RSQ = 9.88), 2) Interpersonal Reactivity Index (IRI < 45), or 3) State-based Difficulties in Emotion Regulation Scale (S-DERS = 46.97); age 18 to 65; sufficient German language comprehension, informed consent
acute risk of suicide; other current axis I disorders as primary diagnosis; schizophrenia, bipolar I disorder, organic disorders, substance dependence fulfilling criteria within the last 6 months; antisocial or borderline personality disorder (BPD; traits are allowed); severe cognitive impairment, serious medical condition (interfering with participation in regular sessions), other ongoing psychotherapy or psychotropic medication except selective serotonin reuptake inhibitor (SSRI) / serotonin–norepinephrine reuptake inhibitor (SNRI) if stable for at least three weeks before inclusion (fluoxetin four weeks)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Rating Scale for Depression (HRSD-24) at the conclusion of the 16-week treatment period, as measured by blind, independent raters.
- Secondary Outcome Measures
Name Time Method Post-Treatment & Follow-Up (6 months):<br>1. Rejection Sensitivity Questionnaire (RSQ) <br>2. Interpersonal Reactivity Index (IRI) <br>3. State-based Difficulties in Emotion Regulation Scale (S-DERS) <br>4. HRSD-24 Wert 6 months after end of treatment <br>5. Response and remission rates (response: at least 50% reduction of the baseline HRSD-24 and <16; remission: HRSD-24 Wert = 8)<br>6. Social and Occupational Functioning Assessment Scale (SOFAS) <br>7. WHO Quality of Life Instrument (WHOQOL-BREF) <br>8. Mentalization Questionnaire (MZQ) <br>9. Beck Depression Inventory (BDI-II)<br>10. Beck Anxiety Scale (BAI)<br>11. Patient Health Questionnaire (PHQ-9)<br>12. Experiences in Close Relationships Revised (ECR-RD)<br>13. Scale of Body Connection (SBC)<br>14. Working Alliance Inventory (WAI)