An implementation evaluation of the physical activity counseling for in-patients with major depressive disorder (PACINPAT) intervention: a randomized controlled trial.

BACKGROUND: The physical activity counseling for in-patients with major depression (PACINPAT) randomized controlled trial was launched to tackle physical inactivity for in-patients with major depressive disorder. Evidence shows that despite potential treatment effects, physical inactivity is prevalent in this population. To contribute to the assessment of how this in-person and remote, theory-based, individually tailored intervention was designed, received and effected behavior, the aim of this study was to evaluate its implementation. METHODS: This implementation evaluation was conducted within a multi-center randomized controlled trial according to the Process Evaluation Framework by the Medical Research Council including the analysis of reach, dose, fidelity and adaptation. Data were collected from the implementers and the participants randomized to the intervention group of the trial. RESULTS: The study sample comprised 95 physically inactive in-patients (mean age: 42 years, 53% women) with diagnosed major depressive disorder. The intervention reached the intended population (N = 95 in-patients enrolled in the study). The intervention dose varied between early dropouts (counseling sessions, M = 1.67) and study completers with some participants receiving a low dose (counseling sessions, M = 10.05) and high dose (counseling sessions, M = 25.37). Differences in the attendance groups were recognizable in the first two counseling sessions (duration of counseling session about 45 min in early dropouts versus 60 min for study completers). Fidelity of the in-person counseling content was partly achieved and adapted, whereas that of the remote counseling content was well achieved. Participants (86% at follow up) reported satisfaction with the implementers of the intervention. Adaptations were made to content, delivery mode and dose. CONCLUSION: The PACINPAT trial was implemented in the intended population, in varying doses and with adaptations made to in-person counseling content and remote counseling dose. These findings are key to understanding outcome analyses within the PACINPAT trial, further developing interventions and contributing to implementation research among in-patients with depressive disorders. TRIAL REGISTRATION: ISRCTN, ISRCTN10469580 , registered on 3rd September 2018.

Exploring psychosocial mediators of remote physical activity counselling: a secondary analysis of data from a 1-year randomized control trial (Movingcall).

The present study investigated whether psychosocial determinants mediate the effect of a telephone coaching intervention on physical activity levels. Two hundred eighty-eight adults were randomly assigned to a six-month telephone coaching intervention (n = 12 calls) or a control group receiving a single written recommendation. Seven psychosocial determinants as defined in the MoVo model as well as objective and self-reported physical activity levels were measured after 6 and 12 months. Participants also reported which taught intervention strategies (behavior change techniques) they perceived as most useful. Structural equation modeling was used to determine the mediating role of psychosocial determinants. Up to 227 participants with complete data on psychosocial determinants and physical activity were included in the mediation analyses. Compared to the control group, a greater increase in self-reported and objectively assessed physical activity levels was observed the coaching intervention group. The mediation analyses showed that the intervention had a positive effect on self-efficacy, outcome expectations and intention strength after 6 months and on action planning and barrier management after 6 and 12 months. Increases in objectively assessed physical activity after 6 months were mediated by increased barrier management. None of the other psychosocial determinants worked as mediating factors on self-reported or objectively assessed physical activity. The participants perceived 'action planning' and 'problem solving' as the most useful strategies to increase their physical activity levels. Further understanding of working mechanisms of remote physical activity promotion is needed.

Telephone-Based Coaching and Prompting for Physical Activity: Short- and Long-Term Findings of a Randomized Controlled Trial (Movingcall).

This study analyzed the short- and long-term efficacy of telephone coaching and short message service (SMS) prompting for physical activity (PA) promotion. Two-hundred-and-eighty-eight adults (age: 42 ± 11 years) were assigned randomly to three intervention arms: The intervention groups received 12 bi-weekly telephone calls with (coaching and SMS group) or without (coaching group) additional SMS prompts (n = 48 SMS). The control group received a single written PA recommendation. Self-reported and objective moderate-to-vigorous physical activity (MVPA) levels were assessed by a structured interview and by accelerometer at baseline, after the intervention (6 months), as well as after a no-contact follow-up (12 months). At post-test, self-reported MVPA increased by 173 min/week (95% CI 95 to 252) in the coaching group and by 165 min/week (95% CI 84 to 246) in the coaching and SMS group compared to control. These group differences remained similar in the follow-up test. For the objectively assessed MVPA, the coaching group increased by 32 min/week (95% CI 0.1 to 63) and the coaching and SMS group by 34 min/week (95% CI 1.6 to 66) compared to the control group. In the follow-up test, the objective MVPA levels of the intervention groups no longer differed from baseline, but group differences persisted as the control group decreased below baseline. Additional SMS prompts did not result in a further increase in PA. Telephone coaching can be considered an effective tool for PA promotion.

The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is a widespread and burdensome psychiatric issue. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in this specific and particularly vulnerable population, which often suffers from both mental and physical health problems. Therefore, this study will examine the impact of a lifestyle physical activity counselling intervention on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers among in-patients diagnosed with MDD compared to controls. Secondary purposes are to examine the acceptability and perceived usefulness of the intervention among these patients, to find out whether the effectiveness of the intervention is moderated by genetic factors, and to compare baseline values with an age- and gender-matched group of healthy controls. METHODS: The study is designed as a multi-centric two-arm randomized clinical trial including an intervention group and a placebo control group, allocation concealment, single-blinding, and intention-to-treat analysis. Participants (N = 334) will be continuously recruited from four clinics specialized in the treatment of MDD. The intervention builds on a standardized, theory-based, low-cost lifestyle physical activity counselling programme, which was specifically designed for an in-patient rehabilitation setting. The placebo control condition consists of general instructions about health-enhancing physical activity. Data assessments will take place 2-3 weeks after admission to in-patient treatment (baseline), and 6 weeks (post) and 12 months (follow-up) after discharge from in-patient treatment. The primary outcome is objectively assessed physical activity at follow-up. DISCUSSION: Because regular physical activity has proven to be an important predictor of long-term response and remission in patients with major depression, we believe that our planned study may lay important groundwork by showing how individually tailored lifestyle physical activity counselling can be integrated into given clinical structures. Improving physical activity may have important implications for tackling metabolic and cardiovascular disease and increasing mood and cognitive functioning in this at-risk population, hence limiting the future burden of multiple chronic conditions. Increased physical activity may also reduce the likelihood of future depressive episodes. By moving towards the primary prevention of chronic physical conditions, much can be done to enhance the quality and quantity of life of people with MDD. TRIAL REGISTRATION: ISRCTN, ISRCTN10469580 . Registered on 3 September 2018.

Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall).

Background. Physical inactivity is currently seen as one of the biggest global public health issue. Remote physical activity (PA) promotion programs are expected to be effective if they are individually tailored and include behavior change techniques, personal coaching, and regular prompting. However, it is still not fully understood which intervention components are most effective. This paper describes the rationale and design of a study on an individually tailored remote PA promotion program comparing the efficacy of coaching and prompting with a single written advice. Methods. In total, 288 adults (age 20 to 65 years) were randomly assigned to three different intervention arms of a 6-month-long PA promotion program. A minimal intervention group received a single written PA recommendation. The two remaining groups either received telephone coaching sessions (n = 12 calls) with or without additional short message service (SMS) prompting (n = 48 SMSs for each participant). Data assessment took place at baseline, at the end of the intervention, and after a six-month follow-up-period. The primary outcome of the study was self-reported PA. Objectively assessed PA, psychosocial determinants of PA, well-being, body mass index (BMI), and adherence were assessed as secondary outcomes. Conclusion. Findings of this three-arm study will provide insight into the short and long-term effects of coaching and prompting for PA promotion.

The utility of two interview-based physical activity questionnaires in healthy young adults: Comparison with accelerometer data.

BACKGROUND: Accurate assessment of physical activity is essential to determine the magnitude of the health-related benefits of regular physical activity. While physical activity questionnaires are easy to use, their accuracy in comparison to objective measures has been questioned. The purpose of the present study was to examine the utility of two interview-based questionnaires; a recently-developed instrument, the Simple Physical Activity Questionnaire (SIMPAQ), and the Seven Day-Physical Activity Recall (7DPAR). METHODS: Accelerometer data was collected in 72 university students (50% females). Telephone interviews were conducted to complete the SIMPAQ and the 7DPAR. RESULTS: Significant correlations (p < .001) were found between accelerometer-based moderate-to-vigorous physical activity (MVPA), the amount of self-reported moderate-to-vigorous exercise assessed via the SIMPAQ (rho = .49), and vigorous physical activity assessed via the 7DPAR (rho = .50). Exercise assessed via the SIMPAQ was significantly correlated with the vigorous physical activity score of the 7DPAR (rho = .56, p < .001). While participants needed three minutes less to complete the SIMPAQ (p < .001), participants tended to be more confident about the accuracy of the answers they provided on the 7DPAR (p < .01). CONCLUSIONS: These two questionnaire measures of physical activity performed similarly in a healthy young adult sample. The SIMPAQ can be completed in 15 minutes, which could be an advantage in settings where time for physical activity assessment is limited.