A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Greifswald

About this trial

The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary DSM-5 diagnosis of PDD (300.4, 296.2x, 296.3x)

Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20

Treatment-resistance (TR) (defined by the ATHF-SF or medication intolerance or one psychotherapy at least 25 sessions by a certified therapist in the current episode)

Sufficient knowledge of the German language

Disqualifiers

Bipolar I or II disorder

Active substance use disorders (abstinence shorter than 6 months)

Schizophrenia spectrum and other psychotic disorders

Antisocial personality disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • inpatient CBASP individual therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).

  • inpatient CBASP group therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).

  • inpatient CBASP nurse contact

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 25 min per session).

  • inpatient CBASP exercise therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).

  • outpatient CBASP group therapy

    Behavioral

    During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).

  • inpatient BA individual therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).

  • inpatient BA group therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).

  • inpatient BA nurse contact

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 25 min per session)

  • inpatient BA exercise therapy

    Behavioral

    During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).

  • outpatient BA group therapy

    Behavioral

    During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).

  • algorithm-based study medication

    Drug

    All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse: * 1st line dose escalation (if appropriate) * 2nd line lithium augmentation * 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants * 4th line change of antidepressant.

Treatment groups

396 Participants
are divided into 2 treatment groups
Group A: Cognitive Behavioral Analysis System of Psychotherapy (CBASP)Experimental treatment 6 interventions
Group B: Behavioral Activation (BA)Active comparator 6 interventions

Trial outcomes

Primary outcomes

1

Hamilton Depression Rating Scale (HDRS-24), 24-item version

The change in HDRS-24 item score after 16 weeks will be the primary endpoint. 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.

Time frame
16 weeks

Secondary outcomes

1

Hamilton Depression Rating Scale (HDRS-24), 24-item version

The HDRS-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 HDRS-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.

Time frame
baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 64
2

Inventory of Depressive Symptomatology, Self-Report (IDS-SR)

The IDS-SR is a self-reported measure of depressive symptoms and used to detect change in self-rated depression severity. It shows good psychometric properties. Each item is rated from 0 to 3 by the patient, and all values are added up to an overall score. Total score ranges from 0 to 78, with higher values indicating a higher depression severity.

Time frame
baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 40, 48, 56, 64
3

Brief Symptom Inventory (BSI)

The BSI is a multi-dimensional self-reported measure with a total of nine scales assessing the subjective impairment by physical and psychological symptoms. Each item is rated on a scale from 0 to 5 by the patient and are added up and t-transformed to three global indices: Global Severity Index, Positive Symptom Distress Index, Positive Symptom Total. T-Scores range from 0 to 100, with higher values indicating a higher subjective impairment.

Time frame
baseline, weeks 1, 5, 10, 16, 64
4

Global Assessment of Functioning (GAF)

The GAF is a diagnostic measure used to assess social, occupational and psychological functioning according to DSM-IV. The score ranges from 0 to 100 with a total of ten levels of functioning and is determined by a clinical rater. Higher scores indicate a higher level of functioning and therefore a better outcome.

Time frame
baseline, weeks 1, 5, 10, 16, 64

Other outcomes

1

Childhood Trauma Questionnaire (CTQ)

Childhood maltreatment by the definition of the World Health Organization (WHO) is assessed as a main moderator at baseline. The CTQ measures self-reported childhood trauma on five subscales. Responses are measured on a five point scale, and each subscale score has a range from 5 to 25 points. Higher scores indicate a higher severity in childhood trauma and therefore a worse outcome.

Time frame
Baseline
2

Brain-derived neurotrophic factor (BDNF)

Brain-derived neurotrophic factor (BDNF) methylation as a main moderator.

Time frame
Baseline
3

Inventory of Interpersonal Problems-revised (IIP-32-R)

The IIP-32-R is a self-reported questionnaire that assesses the severity of interpersonal problems on eight scales based on the two-dimensional interpersonal circumplex model as a main mediator. The items are rated on a five-point scale by the patients. A mean score is calculated, ranging from 0 to 4. A higher score indicates a higher severity of interpersonal problems and therefore a worse outcome.

Time frame
Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64
4

Behavioral Activation Depression Scale (BADS)

This self-report is designed to measure weekly changes in avoidance and activation during treatment with Behavioral Activation for depression. The BADS consists of 25 questions on four subscales, each rated on a seven point scale ranging from 0 to 6. The subscales are activation, avoidance/rumination, work/school impairment, and social impairment. A higher total score represents a higher level of activation and therefore a better outcome, while a high score in the subscale social impairment indicates a higher level of impairment and therefore a worse outcome. Scores range from 0 to 150.

Time frame
Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Greifswald

Lead sponsor

German Research Foundation

Collaborator

University of Kassel

Collaborator

University Medicine Greifswald

Collaborator

Charite University, Berlin, Germany

Collaborator

Hannover Medical School

Collaborator

University Hospital Lübeck

Collaborator

Philipps University Marburg

Collaborator

Ludwig-Maximilians - University of Munich

Collaborator

University Hospital Tuebingen

Collaborator

University Hospital, Bonn

Collaborator

Jena University Hospital

Collaborator