Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19–Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial

Background The COVID-19 pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions that aim to improve the elevated levels of psychological distress due to the COVID-19 pandemic. Objective This study aimed to comparatively assess the efficacy of therapist-guided online therapy with that of self-help, internet-based therapy focusing on COVID-19–induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic. Methods This was a 6-week-long pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety or depression among the Omani public amid the COVID-19 pandemic. Participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman; these sessions were conducted in Arabic or English. The psychotherapists utilized cognitive behavioral therapy and acceptance and commitment therapy interventions. Participants in the control group received an automatic weekly newsletter via email containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of cognitive behavioral therapy and acceptance and commitment therapy. The primary outcome was measured by comparing the change in the mean scores of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scale from the baseline to the end of the study (ie, after 6 sessions) between the two groups. The secondary outcome was to compare the proportions of participants with depression and anxiety between the two groups. Results Data from 46 participants were analyzed (intervention group n=22, control group n=24). There was no statistical difference in the baseline characteristics between both groups. Analysis of covariance indicated a significant reduction in the GAD-7 scores (F1,43=7.307; P=.01) between the two groups after adjusting for baseline scores. GAD-7 scores of participants in the intervention group were considerably more reduced than those of participants in the control group (β=−3.27; P=.01). Moreover, a greater reduction in mean PHQ-9 scores was observed among participants in the intervention group (F1,43=8.298; P=.006) than those in the control group (β=−4.311; P=.006). Although the levels of anxiety and depression reduced in both study groups, the reduction was higher in the intervention group (P=.049) than in the control group (P=.02). Conclusions This study provides preliminary evidence to support the efficacy of online therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist-guided online therapy was found to be superior to self-help, internet-based therapy; however, both therapies could be considered as viable options. Trial Registration ClinicalTrials.gov NCT04378257; https://clinicaltrials.gov/ct2/show/NCT04378257

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Efficacy of Six-weeks Therapist Guided Online-Therapy Versus Self-Help Internet-based Therapy on COVID-19 Invoked Anxiety and Depression Among Individuals in Oman During COVID-19 pandemic. An Open Label, Pragmatic Randomized Controlled Trial. (Preprint)

10.2196/preprints.26683 ◽

2020 ◽

Author(s):

Mohammed Al Alawi ◽

Roopa K McCall ◽

Alya Sultan ◽

Naser Al Balushi ◽

Tamadhir Al-Mahrouqi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Psychological Distress ◽

Controlled Trial ◽

Intervention Group ◽

Anxiety And Depression ◽

Online Therapy ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Self Help ◽

E Mail

BACKGROUND The coronavirus (COVID-19) pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions aiming at improving the increased levels of psychological distress arising from the COVID-19 pandemic. OBJECTIVE This study aimed at assessing the efficacy of therapist guided Online-Therapy versus self-help, e-mail delivered, therapy focusing on COVID-19-induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic. METHODS This was a 6-week pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety/depression among the public in Oman amid the COVID-19 pandemic. The participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman in Arabic or English. The Psychotherapists utilized Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) interventions. The participants in the control group received an automatic weekly newsletter via e-mail containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of CBT and ACT. The primary outcome was measured by comparing the change in the mean Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scores from baseline to the end of the study (after six sessions) between the two arms. The secondary outcome was comparing the proportions of participants with depression and anxiety in the two groups. RESULTS Data from 46 participants were analyzed (22 in intervention arm and 24 in control arm). There was no statistical difference in baseline characteristics between both arms. Analysis of covariance indicated a significant reduction in the GAD scores (F(1,43) = 7.307; P = 0.010) between the two arms after adjusting for baseline scores. The intervention arm GAD scores reduced more than those of the control arm (B = -3.27; P = 0.010). The intervention arm had a greater reduction in PHQ-9 mean scores (F(1,43) = 8.298; P = 0.006) when compared to the control arm (B = -4.311; P = 0.006). While the levels of anxiety and depression reduced in both study arms, the reduction was higher in the intervention group (P values of <0.049 and <0.022, respectively). CONCLUSIONS This study provides preliminary evidence to support the efficacy of Online-Therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist guided Online-Therapy was noted to be superior to self-help Internet-based therapy, however, both therapies could be considered as viable options. CLINICALTRIAL ClinicalTrials.gov NCT04378257

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Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714003006 ◽

2015 ◽

Vol 45 (9) ◽

pp. 1907-1917 ◽

Cited By ~ 26

Author(s):

K. Imamura ◽

N. Kawakami ◽

T. A. Furukawa ◽

Y. Matsuyama ◽

A. Shimazu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Major Depressive ◽

Randomized Controlled ◽

Dsm Iv

BackgroundIn this study we investigated whether an Internet-based computerized cognitive behavioral therapy (iCBT) program can decrease the risk of DSM-IV-TR major depressive episodes (MDE) during a 12-month follow-up of a randomized controlled trial of Japanese workers.MethodParticipants were recruited from one company and three departments of another company. Those participants who did not experience MDE in the past month were randomly allocated to intervention or control groups (n = 381 for each). A 6-week, six-lesson iCBT program was provided to the intervention group. While the control group only received the usual preventive mental health service for the first 6 months, the control group was given a chance to undertake the iCBT program after a 6-month follow-up. The primary outcome was a new onset of DSM-IV-TR MDE during the 12-month follow-up, as assessed by means of the web version of the WHO Composite International Diagnostic Interview (CIDI), version 3.0 depression section.ResultsThe intervention group had a significantly lower incidence of MDE at the 12-month follow-up than the control group (Log-rank χ2 = 7.04, p < 0.01). The hazard ratio for the intervention group was 0.22 (95% confidence interval 0.06–0.75), when estimated by the Cox proportional hazard model.ConclusionsThe present study demonstrates that an iCBT program is effective in preventing MDE in the working population. However, it should be noted that MDE was measured by self-report, while the CIDI can measure the episodes more strictly following DSM-IV criteria.

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Effects of a psychological nursing intervention on prevention of anxiety and depression in the postpartum period: a randomized controlled trial

Annals of General Psychiatry ◽

10.1186/s12991-020-00320-4 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Hongling Liu ◽

Yang Yang

Keyword(s):

Postpartum Depression ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Behavior Intervention ◽

Anxiety And Depression ◽

Control Group ◽

Cognitive Behavior ◽

Randomized Controlled ◽

Primiparous Women

Abstract Background Anxiety and postpartum depression are the most common psychological problems in women after delivery. Cognitive behavior intervention has been reported to have an effect in the therapy of postpartum depression. This research aimed to investigate whether cognitive behavior intervention could prevent the pathogenesis of postpartum depression in primiparous women. Methods In this randomized controlled trial, primiparous women who were prone to postpartum depression were recruited. Participates in the control group received routine postpartum care and those in the intervention group received both routine postpartum care and cognitive behavior intervention. Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Edinburgh Postpartum Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI) were evaluated before and after the intervention. Results In the intervention group, the post-intervention scores of HAMA, HAMD, EPDS and PSQI were all significantly lower than the baseline scores (p = 0.034, p = 0.038, p = 0.004, p = 0.014, respectively). The proportion of participants with postpartum depression in the intervention group (11.5%) was significantly lower than the control group (24.3%) after the 6-week intervention. Participants in the intervention group were significantly more satisfied with the care than those in the control group (p = 0.032). Conclusion This research provided evidence that cognitive behavioral intervention in postpartum period could alleviate anxiety and depression in primiparous women, and inhibit the pathogenesis of postpartum depression. Trial registry This clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000040076).

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

10.21203/rs.3.rs-19471/v1 ◽

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

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An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.15011 ◽

2019 ◽

Author(s):

Christina Gallinat ◽

Markus Moessner ◽

Holger A Haenssle ◽

Julia K Winkler ◽

Matthias Backenstrass ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Willingness To Participate ◽

Skin Picking ◽

Randomized Controlled ◽

Self Help ◽

Skin Picking Disorder ◽

Post Assessment

BACKGROUND In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population. OBJECTIVE This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking–related impairment, dimensions of skin picking, and general psychological impairment. METHODS A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report. RESULTS The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen <italic>d</italic>=0.67) and especially on the subscale Symptom Severity (Cohen <italic>d</italic>=0.79). No effects on secondary outcomes were found. CONCLUSIONS This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial. CLINICAL TRIAL German Clinical Trial Register DRKS00015236; https://www.ncbi.nlm.nih.gov/pubmed/31011654 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1016/j.conctc.2018.100315

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Feasibility randomised controlled trial of a self-help acceptance and commitment therapy intervention for grief and psychological distress in carers of palliative care patients

Journal of Health Psychology ◽

10.1177/1359105317715091 ◽

2017 ◽

Vol 25 (3) ◽

pp. 322-339 ◽

Cited By ~ 3

Author(s):

Esther L Davis ◽

Frank P Deane ◽

Geoffrey CB Lyons ◽

Gregory D Barclay ◽

Joan Bourne ◽

...

Keyword(s):

Palliative Care ◽

Psychological Distress ◽

Acceptance And Commitment Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Treatment As Usual ◽

Self Help ◽

Commitment Therapy ◽

Acceptance And Commitment

We tested the feasibility and preliminary effectiveness of an acceptance and commitment therapy self-help intervention for grief and psychological distress in carers of patients in palliative care. Carers were randomised to the control group, which received treatment as usual, or the intervention group, which received treatment as usual plus an acceptance and commitment therapy–based self-help booklet and telephone support call. Questionnaires were completed at baseline, 1-month post-allocation and 6 months post-loss. Results indicated that the intervention was generally feasible and viewed as acceptable to carers. Preliminary effectiveness analyses showed at least a small effect in acceptance, valued-living, grief and psychological distress.

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Preliminary evaluation of a culturally adapted CBT-based online programme for depression and anxiety from a lower middle-income country

The Cognitive Behaviour Therapist ◽

10.1017/s1754470x21000313 ◽

2021 ◽

Vol 14 ◽

Author(s):

Madeeha Latif ◽

Falahat Awan ◽

Mirrat Gul ◽

M. Omair Husain ◽

M. Ishrat Husain ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Mental Disorders ◽

Common Mental Disorders ◽

Controlled Trial ◽

Intervention Group ◽

Anxiety And Depression ◽

Middle Income ◽

Randomized Controlled ◽

Self Help ◽

Culturally Adapted

Abstract Online cognitive behaviour therapy (CBT), self-help and guided self-help (GSH) interventions have been found to be efficacious and cost-effective for treatment of anxiety and depression, but there are limited data from low- and middle-income countries on culturally adapted digital interventions for these common mental disorders. The aim of this study was to investigate the feasibility and acceptability of an online culturally adapted CBT-based guided self-help (CaCBT-GSH) for patients with anxiety and depression in Pakistan. This randomized controlled trial recruited 39 participants from primary care in Karachi, Pakistan and randomized them to two groups. The intervention group received seven modules of CaCBT-GSH plus treatment as usual (TAU) over 12 weeks. The control group was a waitlist control plus TAU. The primary outcomes were feasibility and acceptability. Clinical outcomes included results from the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHODAS 2). Assessments were carried out at baseline and at 12 weeks. All 39 individuals who met eligibility criteria for the study agreed to participate. Adherence to the intervention was excellent, with 85% (17/20) completing more than five modules. Statistically significant improvements were found in all clinical outcomes in the intervention group. This was the first trial of an online CaCBT-GSH intervention, which was found to be feasible and acceptable to Pakistani patients with anxiety and depression. CaCBT-GSH may help improve symptoms, depression, anxiety and overall functioning in this population. The results provide rationale for a larger, confirmatory randomized controlled trial of digital CaCBT-GSH. Key learning aims (1) Leveraging digital and virtual platforms to deliver psychosocial interventions may contribute to addressing the significant treatment gap in low-resource settings. (2) CBT-informed guided self-help is feasible and acceptable in the treatment of common mental disorders in Pakistan. (3) The results of this study merit a larger, appropriately powered confirmatory randomized controlled trial to determine clinical and cost effectiveness.

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Measuring the Effects of Nurse-Practitioner (NP)-Led Care on Depression and Anxiety Levels in People with Multiple Sclerosis: A Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-537085/v1 ◽

2021 ◽

Author(s):

Penelope Smyth ◽

Kaitlyn E Watson ◽

Ross T. Tsuyuki

Keyword(s):

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Family Physicians ◽

Anxiety And Depression ◽

Control Group ◽

Depression And Anxiety ◽

Randomized Controlled ◽

Anxiety Levels

Abstract Background Canada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Specialized NPs provide advanced skills to those with complex medical conditions, with potential to enhance the health, functioning and quality of life for PwMS. This study aims to determine the effect of Nurse Practitioners (NPs) on depression and anxiety levels in PwMS. Methods We will perform a parallel randomized controlled trial. PwMS who are followed by general private-practice neurologists will be randomly assigned to the intervention group (NP-led care) or the ‘usual care’ control group (general neurologist or family physician and registered nurse support). In the intervention group, the NP will assess and provide care to the MS patient and their caregiver at a baseline visit, with 3-month and 6-month follow-up visits. PwMS in the control group will receive usual care provided by their community neurologists or family physicians with the standard assistance provided by registered nurses experienced in MS care. The primary outcome will be the difference in change in the patient’s anxiety and depression scores as measured by the validated Hospital Anxiety and Depression Scale (HADS) questionnaire at 3 months. Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to health-care professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire. Discussion Findings from this study will contribute to exploring benefits of advanced nursing practitioner interventions for PwMS followed by general neurologists and family physicians in a community setting. It will provide evidence of the benefits of NP-led care for PwMS and offer an alternative healthcare resource for management of MS. Trial Registration: Retrospectively registered June 26, 2020 at ClinicalTrials.gov (Unique protocol ID:Pro00069595);url: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009VEL&selectaction=Edit&uid=U00053N2&ts=4&cx=5oyfdk Protocol version: January 2017, version 1

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Self-administration of medication: a pragmatic randomized controlled trial of the impact on dispensing errors, perceptions, and satisfaction

Therapeutic Advances in Drug Safety ◽

10.1177/2042098620904616 ◽

2020 ◽

Vol 11 ◽

pp. 204209862090461 ◽

Cited By ~ 1

Author(s):

Charlotte Arp Sørensen ◽

Marianne Lisby ◽

Charlotte Olesen ◽

Ulrika Enemark ◽

Signe Bredsgaard Sørensen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Medication List ◽

Self Administration ◽

Participant Satisfaction ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Dispensing Errors

Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing. Methods: A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors. Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital.

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An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15011 ◽

2019 ◽

Vol 21 (9) ◽

pp. e15011

Author(s):

Christina Gallinat ◽

Markus Moessner ◽

Holger A Haenssle ◽

Julia K Winkler ◽

Matthias Backenstrass ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Willingness To Participate ◽

Skin Picking ◽

Randomized Controlled ◽

Self Help ◽

Secondary Outcomes ◽

Skin Picking Disorder ◽

Post Assessment

Background In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population. Objective This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking–related impairment, dimensions of skin picking, and general psychological impairment. Methods A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report. Results The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found. Conclusions This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial. Trial Registration German Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236 International Registered Report Identifier (IRRID) RR2-10.1016/j.conctc.2018.100315

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