Exercise treatment for depression: a randomized, controlled study of a computeranimated endurance sport in a virtual setting – Effects on depression, self-efficacy, acceptability and feasibility

Not Applicable

Recruiting

Conditions: F32
F33
Depressive episode
Recurrent depressive disorder

Registration Number: DRKS00004882

Lead Sponsor: Schlosspark-KlinikAbt. Psychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Major depression according to the ICD-10 (single or recurrent episode ; F32, F33), confirmed by the Standardized Diagnostic Interview for Mental Disorders, „Mini-DIPS
2.HAMD-17 score of at least 15
3.Participants have a sufficient physical fitness to carry out the training sessions
4.Participants are not included in other sport therapies
5.Participants have to be at least 18 years old
6.Informed consent: Participants provided verbally and written informed consent after they were in detail verbally and written informed about the study and had sufficient time (at least one night) for consideration by given capacity to consent
7.Ability to complete self administered questionnaires in German.
8. Suitability for study-related physical activity by internal medicine preliminary assessment

Exclusion Criteria

1.Serious internistic diseases, particularly cardiopulmonary or musculoskeletal disorders.
2.Manic or hypomanic episodes in the past (bipolar disorder)
3.Pregnant, or breast feeding at the time of assessment
4.Aches and pains at the musculoskeletal system
5.Epilepsy
6.Schizophrenic disorder (F2)
7.Organic, including symptomatic, mental disorders (F0)
8.Judicial hospitalization / lawful support or mentoring

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the depressive symptoms, assessed with the Hamilton Depression Rating Scale, 17 item version (HAMD-17). Four measure time points: baseline (T1), during the intervention (T2), post intervention (T3) and 1-week-follow-up (T4).

Secondary Outcome Measures

Name	Time	Method
1.„Skala zur Allgemeinen Selbstwirksamkeitserwartung (SWE), self-efficacy, measure time points: T1-T4 <br>2.„Beck-Depressions-Inventar II (BDI-II), severity of the depressive symptoms, self rating, measure time points: T1-T4<br>3.”Clinical Global Impression (CGI), to measure symptom severity and efficacy of the treatment, measure times: T1-T4<br>4.„ Rated Perceived Exertion (RPE), to asses subject's perception of exertion (measure times: first and last day of the trainig and T2).<br>5.Acceptability of and the attitude to the computer-animated endurance sport with the „Aktzeptanzfragebogen, measure times: T4<br>6.Heart rate in all training sessions with a heart rate monitor watch<br>7.Scores, achieved by the participants in the computer-animated endurance sport <br>8.Rate of responders <br>9.Rate of remitters