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1.
Contemp Clin Trials ; 111: 106597, 2021 12.
Article in English | MEDLINE | ID: mdl-34653650

ABSTRACT

Sexual abuse of boys and men is a public health problem that has received relatively little attention from clinical scholars and researchers. Given unique pathways for development of and recovery from trauma-related emotional distress, sexual abuse survivors who identify as men may require distinct psychosocial interventions to engage in formal mental health care and assist in symptom reduction. This paper describes the rationale for and methodology of a randomized controlled trial comparing the effectiveness of Motivational Interviewing (MI) versus MI with affirmative care (MI-AC) for sexual and gender minority men who have been sexually traumatized. This study is designed to randomly assign 356 participants to either condition of six online group sessions delivered by two trained peers with lived experience of sexual trauma. Assessments will be conducted at baseline, post-treatment, 60- and 120-day follow-up. The primary hypotheses are that participants assigned to MI-AC, compared to those in MI only, will report reduced symptoms of depression and increased levels of engagement in formal mental health treatment. Additional hypotheses relate to secondary outcome variables, including post-traumatic stress disorder, suicidality, and substance use.


Subject(s)
Motivational Interviewing , Sexual and Gender Minorities , Humans , Male , Motivational Interviewing/methods , Sexual Behavior , Sexual Trauma , Survivors
2.
Contemp Clin Trials ; 91: 105990, 2020 04.
Article in English | MEDLINE | ID: mdl-32184198

ABSTRACT

Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.


Subject(s)
Implosive Therapy/methods , Internet , Stress Disorders, Post-Traumatic/therapy , Veterans/psychology , Age Factors , Female , Humans , Male , Narration , Research Design , Sex Factors , Socioeconomic Factors
3.
Contemp Clin Trials ; 64: 41-48, 2018 01.
Article in English | MEDLINE | ID: mdl-29128649

ABSTRACT

Improved accessibility of effective and efficient evidence-based treatments (EBTs) for military personnel suffering with posttraumatic stress disorder (PTSD) is an urgent need to meet the growing demand for timely care. In addition, a better understanding of the mechanism of action of behavioral therapy can inform the delivery of care to meet accessibility demands. Effective EBTs for PTSD are available, but logistical and stigma-related barriers to accessing behavioral healthcare can deter military personnel from receiving these treatments. Web-based treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-based treatments for PTSD appears promising; however, they were not developed based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-based treatment of PTSD using a well-established evidence-based treatment, nor delineated the biological mechanisms through which a web-based treatment exerts its effects. This paper describes the rationale and methods of a randomized controlled trial comparing the efficacy and potential biological mediators of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8weeks compared to 10 sessions of in-person Present-Centered Therapy (PCT) delivered over 8weeks by a therapist in 120 active duty military personnel and veterans with PTSD.


Subject(s)
Implosive Therapy/methods , Internet , Military Personnel , Stress Disorders, Post-Traumatic/therapy , Veterans , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Research Design , Telemedicine/methods , Young Adult
4.
J Med Internet Res ; 16(10): e232, 2014 Oct 14.
Article in English | MEDLINE | ID: mdl-25316533

ABSTRACT

BACKGROUND: Although relatively new, the field of e-mental health is becoming more popular with more attention given to researching its various aspects. However, there are many areas that still need further research, especially identifying attrition predictors at various phases of assessment and treatment delivery. OBJECTIVE: The present study identified the predictors of posttreatment assessment completers based on 24 pre- and posttreatment demographic and personal variables and 1 treatment variable, their impact on attrition bias, and the efficacy of the 5 fully automated self-help anxiety treatment programs for generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). METHODS: A complex algorithm was used to diagnose participants' mental disorders based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision; DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders were offered an online 12-week disorder-specific treatment program. A total of 3199 individuals did not formally drop out of the 12-week treatment cycle, whereas 142 individuals formally dropped out. However, only 347 participants who completed their treatment cycle also completed the posttreatment assessment measures. Based on these measures, predictors of attrition were identified and attrition bias was examined. The efficacy of the 5 treatment programs was assessed based on anxiety-specific severity scores and 5 additional treatment outcome measures. RESULTS: On average, completers of posttreatment assessment measures were more likely to be seeking self-help online programs; have heard about the program from traditional media or from family and friends; were receiving mental health assistance; were more likely to learn best by reading, hearing and doing; had a lower pretreatment Kessler-6 total score; and were older in age. Predicted probabilities resulting from these attrition variables displayed no significant attrition bias using Heckman's method and thus allowing for the use of completer analysis. Six treatment outcome measures (Kessler-6 total score, number of diagnosed disorders, self-confidence in managing mental health issues, quality of life, and the corresponding pre- and posttreatment severity for each program-specific anxiety disorder and for major depressive episode) were used to assess the efficacy of the 5 anxiety treatment programs. Repeated measures MANOVA revealed a significant multivariate time effect for all treatment outcome measures for each treatment program. Follow-up repeated measures ANOVAs revealed significant improvements on all 6 treatment outcome measures for GAD and PTSD, 5 treatment outcome measures were significant for SAD and PD/A, and 4 treatment outcome measures were significant for OCD. CONCLUSIONS: Results identified predictors of posttreatment assessment completers and provided further support for the efficacy of self-help online treatment programs for the 5 anxiety disorders. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).


Subject(s)
Anxiety/psychology , Anxiety/therapy , Internet , Models, Psychological , Adolescent , Adult , Aged , Aged, 80 and over , Bias , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome , Young Adult
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