Randomized clinical trial of medical qigong on quality of life, fatigue, side effects, mood, status, and inflammation of cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9617-9617
Author(s):  
B. Oh ◽  
P. Butow ◽  
B. Mullan ◽  
S. Clarke ◽  
P. Beale ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Side Effects ◽  
Sleep Disturbance ◽  
Usual Care ◽  
Cancer Patients ◽  
Intervention Group ◽  
Control Group ◽  
Usual Care Control Group

9617 Background: The quality of life (QOL) of cancer patients is often diminished due to the side effects of treatment and symptoms of the disease itself. This study examines the impact of Medical Qigong (MQ), including gentle exercise and relaxation through meditation and breathing exercise based on the Chinese Medicine theory of energy channels, on quality of life (QOL), fatigue, side effects, mood status and inflammation. Methods: One hundred sixty two patients diagnosed with a range of cancers recruited from three university teaching hospitals were randomly assigned to two groups: a control group (n=83) that received usual health care and an intervention group (n=79) who participated in a MQ program for 10 weeks in addition to receiving usual health care at the hospital. Quality of life and symptoms were measured by the FACT-G, cancer related fatigue by FACT-F and mood status by POMS. The inflammatory marker serum C-reactive protein (CRP) was also monitored serially. Results: Regression analysis indicated that the MQ intervention group significantly improved on measures of overall QOL (t144= -5.761, p<0.001), fatigue (t153= -5.621, p<0.001), mood disturbance (t122=2.346, p=0.021) and inflammation (CRP) (t99=2.042, p<0.044) compared to the usual care control group after controlling for baseline variables. Analysis of the FACT-G subscales revealed that the MQ intervention group also significantly improved in satisfaction with sex life (t92=-3.783, p<0.001) and reduced side effects of nausea (t152=-2.071, p=0.040) and sleep disturbance (t150=-2.603, p=0.010) compared to the usual care control group. Pain was improved in both intervention and control groups. Conclusions: This study suggests that MQ with usual health care can improve overall QOL, fatigue, positive mood status and reduce the side effects of nausea, sleep disturbance and inflammation of cancer patients. This study supports the use of MQ as an intervention for cancer care. No significant financial relationships to disclose.

scholarly journals The Effects of Individual Diet Therapy on Food Intake, Quality of Life, and Related Serum Proteins in Patients with Breast Cancer: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Azadeh Fallah ◽  
Kiana Parnian ◽  
Hamid Abdolazimi ◽  
Sajjad Tezerji ◽  
Zohreh Mazloom
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Cancer Patients ◽  
Serum Proteins ◽  
Intervention Group ◽  
Diet Therapy ◽  
Control Group ◽  
Nutritional Needs

Background: In cancer patients, weight loss due to malnutrition has a significant impact on the patients’ treatment and quality of life. This study aimed to determine the appropriate therapeutic strategy to control the side effects of chemotherapy in patients with breast cancer to improve their health, quality of life, and nutritional status. Methods: In our prospective study, we examined gastric cancer patients who were Seventy patients undergoing chemotherapy were included and randomly divided into intervention (n=35) and control groups (n=35). The intervention group received an individualized diet according to their nutritional needs for eight weeks, and the control group received dietary advice on the side effects of chemotherapy. Malnutrition, nutritional barriers, and patients’ quality of life were evaluated by PG-SGA, nutritional barriers, and QLQ-C30 questionnaires. Serum proteins were also assessed at the beginning and the end of the study. Results: The patients’ mean age was 50.91±1.72 years in the intervention group and 51±1.35 in the control group. According to the PG-SGA questionnaire classification, 68.5% of patients had malnutrition at baseline. In the intervention group, the mean score of PG-SGA decreased, which indicated an improvement in patients’ nutritional status. Increased scores in the functional section of QLQC30 and a decrease in the symptom section of this questionnaire indicated the improved quality of life in patients undergoing treatment at the end of the intervention. Albumin (P<0.001) and hemoglobin (P<0.001) levels increased in the intervention group, while there were no significant changes in these variables of the control group. Serum levels of ferritin did not show significant changes in either the intervention or the control group. Conclusion: Identifying nutritional barriers in breast cancer patients and individual diet therapy based on these barriers and nutritional needs reduces nutritional barriers. Consequently, malnutrition would decline, and the quality of life may enhance in these patients.

scholarly journals A Two-Arm Randomized Pilot Study to Evaluate the Impact of a Mobile Health App on Quality of Life in Patients on Oral Anti-Cancer Medications (Preprint)

2018 ◽  
Author(s):  
Nils Fischer ◽  
Stephen Agboola ◽  
Ramya Palacholla ◽  
Mursal Atif ◽  
Joseph Kvedar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Cancer Patients ◽  
Intervention Group ◽  
Continuous Variable ◽  
Care Quality ◽  
Control Group ◽  
Anti Cancer ◽  
The Impact

BACKGROUND CORA is a personalized smartphone-based self-management app designed to help cancer patients on oral anti-cancer medications manage medication, medication side-effects, and symptoms with the overall goal of improving their quality of life. OBJECTIVE To evaluate the effect of CORA on quality of life in patients on oral anti-cancer medications. METHODS Eighty-four patients were randomized to either an intervention group that received CORA plus usual care or a control group that received usual care. Quality of life was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale administered at enrollment, 6 and 12 weeks. Engagement with the app was assessed by determining the unique days using the app. We evaluated the effect of engagement on FACIT-F both as a continuous variable (days using the app) and as a categorical outcome (low, medium, and high). Group differences for all outcomes over the study period were assessed using repeated measures mixed model analysis. RESULTS Relative to the control group, the intervention group improved FACIT-F by 0.36 (95% CI 0.10-0.61) P=.006 per week over the study period. As a continuous variable, each additional day using the app was significantly associated with an improved FACIT-F score per week in the study [0.0060 (95% CI -0.000034-0.012), P=.05]. Within the intervention group that used the app, those who were most engaged with the app were significantly more likely to improve their quality of life over the study relative to the least engaged group [0.37 per week (95% CI 0.19-1.94), P=.05]. CONCLUSIONS CORA may have significantly improved quality of life (FACIT-F) in cancer patients over 12 weeks. Smartphone applications may positively impact health and behavioral outcomes in cancer patients on oral anti-cancer medications.

Medical Qigong for Cancer Patients: Pilot Study of Impact on Quality of Life, Side Effects of Treatment and Inflammation

2008 ◽  
Vol 36 (03) ◽  
pp. 459-472 ◽  
Author(s):  
Byeongsang Oh ◽  
Phyllis Butow ◽  
Barbara Mullan ◽  
Stephen Clarke
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Side Effects ◽  
Cancer Treatment ◽  
Medical Care ◽  
Sample Size ◽  
Cancer Patients ◽  
Intervention Group ◽  
Control Group

Quality of life (QOL) of cancer patients is often diminished due to the side effects of treatment and symptoms of the disease itself. Medical Qigong (coordination of gentle exercise and relaxation through meditation and breathing exercise based on Chinese medicine theory of energy channels) may be an effective therapy for improving QOL, symptoms and side effects, and longevity of cancer patients. In this pilot study, the feasibility, acceptability, and impact of Medical Qigong (MQ) were evaluated on outcomes in cancer patients. Thirty patients diagnosed with heterogeneous cancers, were randomly assigned to two groups: a control group that received usual medical care and an intervention group who participated in a MQ program for 8 weeks in addition to receiving usual medical care. Randomization was stratified by completion of cancer treatment ( n = 14) or under chemotherapy ( n = 16). Patients completed measures before and after the program. Quality of life and symptoms were measured by the EORTC QLQ-C 30 and progress of disease by the inflammation biomarker (CRP: c-reactive protein) via a blood test was assessed. The MQ intervention group reported clinically significant improved global QOL scores pre- and post-intervention. The MQ intervention also reduced the symptoms of side effects of cancer treatment and inflammation biomarker (CRP) compare to the control group. Due to the small sample size, however, the results were not statistically significant between treatment and the control groups. Data from the pilot study suggest that MQ with usual medical treatment can enhance the QOL of cancer patients and reduce inflammation. This study needs a further investigation with a larger sample size.

Automatic inpatient palliative care consultation (PCC): Too little, too late to impact quality of life for advanced cancer patients?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20565-e20565
Author(s):  
Gabrielle Betty Rocque ◽  
Toby Christopher Campbell ◽  
Anne Elizabeth Barnett ◽  
Renae M Quale ◽  
Jens C. Eickhoff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Services ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Patient Reported ◽  
Small Patient Population

e20565 Background: Patients with advanced cancer who are hospitalized have high symptom burden and a short life expectancy, which may warrant PCC. Methods: Using sequential cohorts, we prospectively assessed implementation of automatic PCC for hospitalized cancer patients. The primary outcome was hospice utilization. Secondary outcomes included evaluation of changes in quality of life (FACIT-PAL), symptoms (ESAS), satisfaction (FAMCARE), and anxiety and depression (HADS). Surveys were administered at baseline, 2 weeks and 3 months post-hospitalization. Chart abstraction was utilized to assess demographics, resource use, and survival information. Results: Patients were evaluated consecutively (65 in the control group, 70 in the intervention). At admission, 91% reported uncontrolled symptoms: 52% pain; 15% dyspnea. 60% of intervention patients received PCC during their first admission. 54 patients completed surveys (29 control group, 25 PCC group), 64 patients declined or were unable to complete surveys, 16 patients were excluded due to language barriers, physician preference, or not receiving surveys. Using an intent-to-treat analysis, there was no difference between patients in the control and the intervention group in FACIT-PAL (119 ± 29 vs 123 ± 30, p = 0.68 ), ESAS (28 ± 14 vs 26 ± 15, p = 0.74) HADS (13 ± 6.6 vs. 12.± 4.7, p = 0.58), or FAMCARE (58 ± 9.1 vs 59 ± 8.6, p = 0.61). In both groups, patients had modest worsening of symptoms and quality of life over the course of the study. Survival and Health Services data analysis, including hospice referral, is proceeding. Conclusions: Automatic PPC had little impact on patient-reported symptoms and quality of life. Limitations included: small patient population; high rate of incomplete surveys, likely due to illness burden; penetration of the PCC was limited to 60% by patient or provider preference and consultant availability. Our primary outcome analysis (hospice utilization) is forthcoming, as are data on survival and Health Services outcomes.

scholarly journals A Children’s Asthma Education Program: Roaring Adventures of Puff (RAP), Improves Quality of Life

2010 ◽  
Vol 17 (2) ◽  
pp. 67-73 ◽  
Author(s):  
Shawna L McGhan ◽  
Eric Wong ◽  
Heather M Sharpe ◽  
Patrick A Hessel ◽  
Puish Mandhane ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Education Program ◽  
Intervention Group ◽  
Asthma Management ◽  
Control Group ◽  
Asthma Education ◽  
Children With Asthma

BACKGROUND: It is postulated that children with asthma who receive an interactive, comprehensive education program would improve their quality of life, asthma management and asthma control compared with children receiving usual care.OBJECTIVE: To assess the feasibility and impact of ‘Roaring Adventures of Puff’ (RAP), a six-week childhood asthma education program administered by health professionals in schools.METHODS: Thirty-four schools from three health regions in Alberta were randomly assigned to receive either the RAP asthma program (intervention group) or usual care (control group). Baseline measurements from parent and child were taken before the intervention, and at six and 12 months.RESULTS: The intervention group had more smoke exposure at baseline. Participants lost to follow-up had more asthma symptoms. Improvements were significantly greater in the RAP intervention group from baseline to six months than in the control group in terms of parent’s perceived understanding and ability to cope with and control asthma, and overall quality of life (P<0.05). On follow-up, doctor visits were reduced in the control group.CONCLUSION: A multilevel, comprehensive, school-based asthma program is feasible, and modestly improved asthma management and quality of life outcomes. An interactive group education program offered to children with asthma at their school has merit as a practical, cost-effective, peer-supportive approach to improve health outcomes.

Randomized Controlled Trial of Yoga Among a Multiethnic Sample of Breast Cancer Patients: Effects on Quality of Life

2007 ◽  
Vol 25 (28) ◽  
pp. 4387-4395 ◽  
Author(s):  
Alyson B. Moadel ◽  
Chirag Shah ◽  
Judith Wylie-Rosett ◽  
Melanie S. Harris ◽  
Sapana R. Patel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Spiritual Well Being ◽  
Multiethnic Sample

Purpose This study examines the impact of yoga, including physical poses, breathing, and meditation exercises, on quality of life (QOL), fatigue, distressed mood, and spiritual well-being among a multiethnic sample of breast cancer patients. Patients and Methods One hundred twenty-eight patients (42% African American, 31% Hispanic) recruited from an urban cancer center were randomly assigned (2:1 ratio) to a 12-week yoga intervention (n = 84) or a 12-week waitlist control group (n = 44). Changes in QOL (eg, Functional Assessment of Cancer Therapy) from before random assignment (T1) to the 3-month follow-up (T3) were examined; predictors of adherence were also assessed. Nearly half of all patients were receiving medical treatment. Results Regression analyses indicated that the control group had a greater decrease in social well-being compared with the intervention group after controlling for baseline social well-being and covariates (P < .0001). Secondary analyses of 71 patients not receiving chemotherapy during the intervention period indicated favorable outcomes for the intervention group compared with the control group in overall QOL (P < .008), emotional well-being (P < .015), social well-being (P < .004), spiritual well-being (P < .009), and distressed mood (P < .031). Sixty-nine percent of intervention participants attended classes (mean number of classes attended by active class participants = 7.00 ± 3.80), with lower adherence associated with increased fatigue (P < .001), radiotherapy (P < .0001), younger age (P < .008), and no antiestrogen therapy (P < .02). Conclusion Despite limited adherence, this intent-to-treat analysis suggests that yoga is associated with beneficial effects on social functioning among a medically diverse sample of breast cancer survivors. Among patients not receiving chemotherapy, yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL.

scholarly journals Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

2020 ◽  
Author(s):  
Toshimi Takano ◽  
Ayako Matsuda ◽  
Noriko Ishizuka ◽  
Yukinori Ozaki ◽  
Koichi Suyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Emotional Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

scholarly journals Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
Faiz Khan ◽  
Nora Granville ◽  
Raja Malkani ◽  
Yash Chathampally
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Lupus Erythematosus ◽  
Therapeutic Intervention ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

BACKGROUND Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown. OBJECTIVE To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone. METHODS In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL). RESULTS A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs –1% for the control group, <i>P</i>&lt;.001), BPI-SF-Pain Interference (25% vs 0%, <i>P</i>=.02), LupusQoL-Planning (17% vs 0%, <i>P</i>=.004), LupusQoL-Pain (13% vs 0%, <i>P</i>=.004), LupusQoL-Emotional Health (21% vs 4%, <i>P</i>=.02), and LupusQoL-Fatigue (38% vs 13%, <i>P</i>&lt;.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs –6%, <i>P</i>=.049), LupusQoL-Physical Health (17% vs 3%, <i>P</i>=.049), and LupusQoL-Burden to Others (33% vs 4%, <i>P</i>=.04) were significant at an unadjusted 5% significance level. CONCLUSIONS A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE. CLINICALTRIAL ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial

10.2196/15001 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e15001
Author(s):  
Sarah MacLean ◽  
Daniel J Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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