Trial document
DRKS00008869
Trial Description
Title
Neurobiological correlates and mechanisms of the augmentation of psychotherapy with endurance exercise in mild to moderate depression
Trial Acronym
SPeED
URL of the Trial
Brief Summary in Lay Language
Exercise therapy and psychotherapy - an evaluation study with patients suffering from major depressive disorder (MDD) (SPeED-Study): Both psychotherapy (cognitive behavioral therapy) and exercise therapy (endurance training) have been found to be an effective treatment for MDD. We investigate the combination of exercise therapy and psychotherapy. Two groups participate in a twelve week endurance training (supervised training in small groups, twice weekly, 60 minutes). The intensity of the endurance training differs between the two groups. Subsequently, these two groups and a third waiting control group receive a cognitive behavioral therapy for twelve weeks. Diagnostic measures at several times include questionnaires (e.g. for depressive symptoms), sports-medical performance diagnostics, blood sampling, and magnetic resonance imaging of the brain. This study will contribute to a better understanding of the underlying mechanisms of the antidepressant effect of exercise therapy and psychotherapy in MDD.
Brief Summary in Scientific Language
Cognitive behavioral therapy (CBT) was found to be an effective treatment for major depressive disorder (MDD) and CBT-related changes of dysfunctional neural activations were shown in recent studies. Despite these effects, remission rates after CBT are not sufficiently high in MDD and the integration of effective augmentation strategies is needed. In recent meta-analyses, exercise therapy (especially endurance training) was reported to be an effective intervention in MDD. However, underlying neural mechanisms of the antidepressant effect of endurance training have been rarely investigated to date, and a better knowledge of these mechanisms especially in combination with CBT is lacking.
The main aim of this study is to investigate underlying physiological, neurobiological, and psychological mechanisms of the augmentation of CBT with endurance training. By applying a longitudinal randomized controlled study design, we investigate if a preceding endurance training intervention will increase the success-rate of a subsequent CBT and if this augmentation effect will be associated with specific neurobiological changes. At four measure points (t1: baseline, t2: after exercise therapy respectively waiting period, t3: after psychotherapy, t4: follow up) primary and secondary outcomes were assessed. A low intensity endurance training group will be included to disentangle physiological from unspecific effects (e.g. general effects of an additional group activity or the attention of an exercise instructor). Specific aims of this study are the association of exercise-induced changes in cortisol and neurotrophine-levels with changes in neural activations during working memory, monetary incentive delay, and emotion-regulation tasks, as well as the prediction of CBT treatment response with these parameters. Results of this study may provide important implications for the development of effective treatment strategies in MDD, concerning the augmentation of CBT by endurance exercise.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00008869
- 2015/07/28
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- yes
- Approved
- EA1/113/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
Secondary IDs
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Health Condition or Problem studied
- F32.0 - Mild depressive episode
- F32.1 - Moderate depressive episode
- F33.0 - Recurrent depressive disorder, current episode mild
- F33.1 - Recurrent depressive disorder, current episode moderate
Interventions/Observational Groups
- High-intensity Endurance training (twice weekly over 12 weeks ca. 60 minutes of moderate to high intensity), subsequently: cognitive behavioral therapy (twice weekly over 12 weeks, 50 minutes)
- Low-intensity Endurance training (twice weekly over 12 weeks, ca. 60 minutes of low intensity), subsequently: cognitive behavioral therapy (twice weekly over 12 weeks, 50 minutes)
- No exercise intervention (control group, 12 weeks), subsequently: cognitive behavioral therapy (twice weekly over 12 weeks, 50 minutes)
- Healthy control group (no intervention, measures like t1 at one measure point (except HCCQ))
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist, assessor, data analyst
- Other
- Treatment
- Factorial
- N/A
- N/A
Primary Outcome
Severity of depressive symptoms measured via self rating (Beck Depression Inventory, BDI) and external rating (Hamilton Rating Scale for Depression, HAM-D) from baseline to follow-up (t1: baseline, t2: after exercise therapy respectively waiting period, t3: after psychotherapy, t4: follow up) .
Secondary Outcome
Brain-derived neurotrophic factor (BDNF) levels are measured taking serum samples (t1-t2 before and after exercise electrocardiogram (ECG) and t3).
In functional magnetic resonance tomography (fMRT) blood-oxygen-level-dependent (BOLD) signal is measured during working memory-, reward learning- and emotion regulation tasks (t1-t3).
Self-efficacy measured via self rating (general self-efficacy scale, GSE)(t1-t4), Emotion-Regulation measured via self rating (emotion-regulation questinnaire, ERQ)(t1-t4), current physical activity measured via self rating (international physical activity questionnaire short form, IPAQ-SF)(t1-t4).
Cognitive abilities such as working memory and inhibiton are measured via neuropsychological tests (digit span, digit symbol, stroop-task, verbal learning and memory test, VLMT)(t1-t4).
Psychological distress measured via self rating (brief symptom inventory, BSI)(t1-t4), dysfunctional attitudes measured via self report (dysfunctional attitude scale, DAS)(t1-t4), pain intensity measured via self-rating (visual analogue scale)(t1-t4), disability related to pain measured via self rating (pain disability index, PDI)(t1-t4), basic psychological needs of relatedness, competence and autonomy measured via self rating (basic psychological need satisfaction and frustration scale, BPNSFS)(t1-t4), the atmosphere of health care in exercise training (t1-t2) and psychotherapy (t2-t3) is measured via self rating (health care climate questionnaire, HCCQ); physical fitness is measured during exercise ECG to calculate the maximum uptake of oxygen (VO2max.) (t1-t2) and blood-samples are taken to identify lactate (t1-t2). Cortisol level will be measured via saliva samples (24h)(t1-t3).
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2015/07/28
- 105
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 65 Years
Additional Inclusion Criteria
The study is conducted with 18- to 65- years old, as physical healthy diagnosed ambulant psychotherapy patients with the main diagnosis of a mild to moderate depressive episode diagnosed according to ICD-10 (F32.0, F32.1), which can also occur in the context of a recurrent depressive disorder (F33.0, F33.1). The presence of a major depressive episode is assured by creating structured clinical interview I for DSM - IV (SCID I) ; Axis I: mental disorders, depression section.
The healthy control group (18-65 years old).
Subjects of the healthy control group are 18-65 years old and have no major depressive disorder.
Exclusion Criteria
Following exclusion criteria are applied: current severe depressive episode with and without psychotic symptoms (F32.2, F32.3, F33.2 or F33.3), current borderline or dissocial personality disorder, acute suicide risk, current or lifetime schizophrenia spectrum disorder, delusional disorders (F2x.x), bipolar affective disorder (F31.x), current dependence (alcohol, heroin, amphetamine, cocaine), minimum period of rest 12 month, current severe neurological diseases and illnesses of central nervous system, severe chronic obstructive pulmonary disease (COPD), coronary heart disease, cardiac insufficiency, anaemia, body mass index > 35 or < 18, language problems, non-correctable hearing and visual impairments, MRI unsuitability, current use of benzodiazepines or beta blockers within the last 7 days, tricyclic antidepressants with a dose of > 50mg per day, neuroleptics with a dose of > 30% of the maximum daily dose, regular endurance training (more than two times per week for 45min).
Addresses
-
start of 1:1-Block address primary-sponsor
- Department Sport- und Gesundheitswissenschaften, Sozial- und Präventivmedizin, Universität Potsdam
- Mr. Prof. Dr. Dr. Michael Rapp
- Am Neuen Palais 10
- 14469 Potsdam
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 03319771050
- 03319774078
- mrapp at uni-potsdam.de
- http://www.uni-potsdam.de/soz-praev-med/index.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- ZPHU - Zentrum für Psychotherapie am Institut für Psychologie der Humboldt-Universität zu Berlin
- Mr. Prof. Dr. Thomas Fydrich
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin
- Mr. Prof. Dr. Andreas Ströhle
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Sport-Gesundheitspark Berlin e.V./ Zentrum für Sportmedizin
- Mr. Dr. Andreas Heißel
- Fritz-Lesch-Str. 29
- Berlin
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- http://www.sport-gesundheitspark.de
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Freie Universität Berlin, Klinische Psychologie und Psychotherapie Erziehungswissenschaften und Psychologie
- Mr. Prof. Dr. Stephan Heinzel
- Habelschwerdter Allee 45
- 14195 Berlin
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 030 838 61564
- 030 838-461564
- stephan.heinzel at fu-berlin.de
- http://www.ewi-psy.fu-berlin.de/einrichtungen/arbeitsbereiche/klinische_psychotherapie/index.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address scientific-contact
- Universität Potsdam, Department Sport- und Gesundheitswissenschaften, Sozial- und Präventivmedizin
- Mr. Dr. Andreas Heißel
- Am Neuen Palais 10
- 14469 Potsdam
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 03319771050
- 03319774078
- andreas.heissel at uni-potsdam.de
- http://www.uni-potsdam.de/soz-praev-med/index.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universität Potsdam, Department Sport- und Gesundheitswissenschaften, Sozial- und Präventivmedizin
- Mr. Dr. Andreas Heißel
- Am Neuen Palais 10
- 14469 Potsdam
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 015903150475
- 03319774078
- psyspeed at hu-berlin.de
- http://www.uni-potsdam.de/fileadmin/projects/soz-praev-med/assets/Forschung/Flyer_SPeED.pdf
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Emanuela Dalla Vecchia Stiftung Depressionsforschung
- Mr.
- Katharinenstrasse 12
- 10711 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 030890470
- 03089047100
- info at stidefo.de
- http://www.stidefo.de
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
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- http://www.dfg.de
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Status
- Recruiting complete, follow-up complete
- 2019/12/31