Effect of Exercise during CBT on Adolescents with a major Depression

Rationale: depression amongs adolescents is a major social problem. According to the Central Bureau of Statistics in the Netherlands (2017) nearly 4% of all youngsters aged 12 to 18 years old(about 37.000 adolescents) stated that they endured a depressive state during six months or longer in 2016.
The most appointed psychological treatment for depression, CBT, is only of mediocre effect (Weersing et al., 2017). An important treatment component in the therapy of depression is activation: the person has to get active again. Exercise on its own, without therapy, has a moderate positive effect on decreasing depressive symptoms within adolescents (Carter et al., 2016). Running therapy proved to be an effective intervention in decreasing depressive symptoms in adults (Bongers & Dijkerman, 2013). Among adolescents the first findings are positive as well.
Also it has been established that exercise, alongside CBT, has an additional effect on decreasing depressive symptoms in adults with a depression (Abdollahi et al., 2017).
A combination of CBT an exercise could possibly lead to better results in adolescents as well, compared to the administration of CBT or exercise alone.

Objective: does exercise during CBT increase the treatment effect in patients aged 13-18 years old with a mediocre or major depression.
Additionally the treatment satisfaction of the patients is measured during the sessions with exercise compared to the session without exercise.

Study design: single case experimental design with alternating treatment interventions (ABC SCED). Every subject always gets treatment as usual: CBT during 12 individual sessions according to an evidence based treatment protocol.
During half of the sessions the patient is asked to perform a simple, moderately intensive exercise activity.
Patients register daily outcomes of their moodlevel(s). After every treatment session they fill in a short treatment satisfaction survey. And they also fill in a validated depression survey (pré, post and follow-up).

Study population: boys and girls aged 13-18 years old with a mediocre or major depression with CBT withoud medication as first choice of treatment.

Intervention:
CBT= a validated depression treatment protocol of 12 weekly individual sessions of 45 minutes, based upon the multidisciplinair guidelines of depression among children and youth. This treatment is care as usual and the same kind of treatment as is offered to patients that do not participate in this study.
Exercise activity= during half of the CBT sessions every patient is instructed to perform a moderately intensive exercise activity over a period of 30 minutes, stepping on a stepper.
The intensity is determind by the so called "talking test", which inholds that the patient is able to conversate with the therapist during the exercise without getting exhausted. In this manner the exercise does not interfere with the CBT.

Main study parameters/endpoints: daily moodlevel of the patient; measured with a daily journal in wich the patient registers his/her moodlevel on a scale of 1-10 with 1 "as sad as can be" and 10 "as happy as can be".
In addition the treatment satisfaction of the patient is measured with the Session Rating Scale, consisting of 4 items.
In order to establish wether CBT and exercise together results in a significant decrease of depression symptoms, the degree of depressive symptoms is measured pré, post en follow-up. For this a validated depression quastionaire is used, the Beck Depression Inventory-II, Dutch revised version, consisting of 21 items.

Hypothesis:
Primairy hypothesis= exercise during CBT increases the mood more then only administrating CBT.
Additional explorative hypothesis= exercise during CBT leads to a higher treatment satisfaction in the patient, compared to administrating CBT only.

Analyses:
In order to determine wether exercise during CBT is more effective then CBT only both regression lines are analysed qualitatively and quantitative. For the qualitative analyses a Single-Case Visual Analysis (SCVA) is used. And the quantitative analyses are performed with the method ALIV; actual and linearly interpolated values (Manolov & Onghena, 2017). This in order to establish wether exercise during CBT is more effective then CBT alone according to the overall results of the mood levels of the patient during the weeks that CBT, respectively exercise during CBT is administrated. The same qualitative and quantitative analyses are performed to establish wether the treatment satisfaction of the patient is higher during the CBT sessions with exercise in contrast to CBT sessions without exercise.

Primairy hypothesis: exercise during CBT increases the mood more then only administrating CBT.
Additional explorative hypothesis: exercise during CBT leads to a higher treatment satisfaction in the patient, compared to administrating CBT only.

The study period (start to finish) is 112 days. During each day the patient registers his/her daily mood level. After every session he/she fills in the Session Rating Scale. And there is a pré, post and follow up measurement (at the start of the baseline phase of 2 weeks, at the end of the intervention phase of 12 weeks and at the end of the follow up phase of 12 weeks) of the severity of depressive symptoms.

CBT treatment protocol: a validated depression treatment protocol of 12 weekly individual sessions of 45 minutes, based upon the multidisciplinair guidelines of depression among children and youth. This treatment is care as usual and the same kind of treatment as is offered to patients that do not participate in this study.

Exercise activity: during half of the CBT session every patient is instructed to perform a moderately intensive exercise activity over a period of 30 minutes, stepping on a stepper.
The intensity is determind by the so called "talking test", which inholds that the patient is able to conversate with the therapist during the exercise without getting exhausted. In this manner the exercise does not interfere with the CBT.