Greater Reduction In Distress Research Articles

Evaluating Solution-Focused Brief Therapy for Chinese Older Adults

Purpose: This study examined the effectiveness of solution-focused brief therapy (SFBT) in alleviating psychological distress of Chinese older adults living in nursing homes. Method: In this randomized pretest–posttest pilot trial, participants ( N = 40) were randomly assigned to SFBT or treatment-as-usual (TAU) and outcomes were assessed with standardized, psychometrically sound measure. Treatment effects were analyzed using analysis-of-covariance, and between-group small-sample-size corrected using Hedges’ g across measures of psychological distress, depression, anxiety, and hope. Results: The results revealed that participants receiving SFBT reported a significantly greater reduction in distress, depression, anxiety, and improvement in hope as compared to those in TAU. Discussion: Results suggest SFBT's efficacy for addressing internalizing disorders in older Chinese adults furthering it as a research-supported intervention. With significant concurrent improvement of older Chinese adults’ hope and their mental health outcomes, this study advances the literature in suggesting hope as a potential intervention mediator.

Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial.

Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

Adapting the Number of Questions Based on Detected Psychological Distress for Cognitive Behavioral Therapy With an Embodied Conversational Agent: Comparative Study.

The high prevalence of mental illness is a critical social problem. The limited availability of mental health services is a major factor that exacerbates this problem. One solution is to deliver cognitive behavioral therapy (CBT) using an embodied conversational agent (ECA). ECAs make it possible to provide health care without location or time constraints. One of the techniques used in CBT is Socratic questioning, which guides users to correct negative thoughts. The effectiveness of this approach depends on a therapist's skill to adapt to the user's mood or distress level. However, current ECAs do not possess this skill. Therefore, it is essential to implement this adaptation ability to the ECAs. This study aims to develop and evaluate a method that automatically adapts the number of Socratic questions based on the level of detected psychological distress during a CBT session with an ECA. We hypothesize that this adaptive approach to selecting the number of questions will lower psychological distress, reduce negative emotional states, and produce more substantial cognitive changes compared with a random number of questions. In this study, which envisions health care support in daily life, we recruited participants aged from 18 to 65 years for an experiment that involved 2 different conditions: an ECA that adapts a number of questions based on psychological distress detection or an ECA that only asked a random number of questions. The participants were assigned to 1 of the 2 conditions, experienced a single CBT session with an ECA, and completed questionnaires before and after the session. The participants completed the experiment. There were slight differences in sex, age, and preexperimental psychological distress levels between the 2 conditions. The adapted number of questions condition showed significantly lower psychological distress than the random number of questions condition after the session. We also found a significant difference in the cognitive change when the number of questions was adapted based on the detected distress level, compared with when the number of questions was fewer than what was appropriate for the level of distress detected. The results show that an ECA adapting the number of Socratic questions based on detected distress levels increases the effectiveness of CBT. Participants who received an adaptive number of questions experienced greater reductions in distress than those who received a random number of questions. In addition, the participants showed a greater amount of cognitive change when the number of questions matched the detected distress level. This suggests that adapting the question quantity based on distress level detection can improve the results of CBT delivered by an ECA. These results illustrate the advantages of ECAs, paving the way for mental health care that is more tailored and effective.

Assessing the effectiveness and observing fidelity of a psychosocial support program for Rohingya refugee mothers and their children in Cox’s Bazar, Bangladesh

IntroductionDespite the well-recognized risk poor maternal mental health poses to early child development, it is still rarely addressed in global health programming, especially in humanitarian settings where access to health and mental health infrastructures may be limited. Recognizing the critical role of maternal psychosocial wellness in addressing the health and development of children in conflict, Action contre La Faim/Action Against Hunger (ACF) developed the Baby Friendly Spaces (BFS) program. BFS is a holistic, evidenced-based psychosocial support program that aims to enhance mothers’ wellbeing, internal resources, and child caring skills in order to create a buffer against the deleterious health and developmental impacts of conflict on children.ObjectivesIn Bangladesh, we sought to evaluate the effectiveness of a psychosocial support program for Rohingya refugee mothers and their malnourished children under two years old living in Cox’s Bazar’s camps.MethodsFor this study, we used a matched pair randomization, where ten BFS program sites were allocated to either continue providing services “as usual” or to an “enhanced BFS program” after re-training and providing continuous supportive supervision of the BFS staff throughout the trial period. 600 mothers and their children were enrolled in the study and attended psychosocial stimulation activities related to child care practices and care for women. Data were collected at baseline and 8-week follow-up. Primary outcomes included maternal distress and wellbeing, functioning, and coping. For implementation purpose, a survey was administered on confidence at work for all BFS staff and a fidelity observation assessment was conducted.ResultsRelative to “as usual” sites, mothers in enhanced implementation sites reported greater reductions in distress (B=-.30) and improvement in wellbeing (B=.58). These differences were small, but marginally significant (p=.058; p=.038) with standard estimation; There was no significant difference between the two groups for daily functioning and coping. BFS providers in “enhanced BFS program” reported higher confidence in service delivery than their colleagues (p=.01). Fidelity varied widely across different components, with some very high and some very low adherence. There tended to be better adherence to procedures in group versus individual sessions and for some specific activities across domains, for enhanced versus standard BFS.ConclusionsFindings highlight the value of innovative study approaches for real-world evidence generation. Small but feasible adjustments to implementation can both improve program delivery for maximizing impact. Consequently, low-intensity psychosocial support activities holds potential for reducing distress and improving subjective well-being of conflict affected mothers.Disclosure of InterestNone Declared

Comorbidity as a moderator of the differential efficacy of transdiagnostic behavior therapy and behavioral activation for affective disorders

ABSTRACT Objective Transdiagnostic psychotherapies have been proposed as an effective means for addressing the needs of patients with multiple, comorbid disorders. Yet, it remains unknown whether transdiagnostic approaches empirically outperform disorder-specific psychotherapies for patients with comorbid disorders. Thus, this study tested whether comorbidity moderated the efficacy of transdiagnostic behavior therapy (TBT) and behavioral activation (BA) for patients with various affective disorders. Methods Data derived from a randomized controlled trial in which 93 treatment-seeking veterans received 12 sessions of TBT (n = 46) or BA (n = 47). Baseline comorbidity was assessed with a diagnostic interview. Patients rated their symptoms and functioning throughout treatment, and therapists recorded premature treatment discontinuation. Results Multilevel models revealed significant interactive effects on changes in symptoms and functioning, but not on the posttreatment levels of these outcomes; whereas patients with more comorbidity experienced greater reductions in distress and symptom interference in TBT compared to BA, those with one disorder had better outcomes in BA. Similarly, whereas patients with more comorbidity were less likely to prematurely discontinue TBT compared to BA, those with one disorder were less likely to prematurely discontinue BA. Conclusions The results lend empirical support to previously untested hypotheses for potential benefits of transdiagnostic psychotherapies. Trial registration: ClinicalTrials.gov identifier: NCT01947647.

TDCS-Augmented in vivo exposure therapy for specific fears: A randomized clinical trial

Exposure therapy is highly effective for anxiety-related disorders, but there is a need for enhancement. Recent trials of adjunctive neuromodulation have shown promise, warranting evaluation of transcranial direct current stimulation (tDCS) as an augmentation. In a double-blind, placebo-controlled trial, contamination- and animal-phobic participants (N = 49) were randomized to active tDCS (1.7 mA, 20 min; n = 27), or sham tDCS (1.7 mA, 30 s; n = 22), followed by 30 min of in-vivo exposure. Active tDCS targeted excitation of the left mPFC and inhibition of the right dlPFC; polarity was counterbalanced for controls. We predicted tDCS would result in accelerated and better maintained gains, contingent on the subsequent in-session response, and baseline negative prognostic indicators. Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize. tDCS was most beneficial given high phobic severity, anxiety sensitivity, and a suboptimal early response. tDCS may promote engagement and response among individuals who are resistant or refractory to standard treatment. tDCS should be applied to more severe anxiety-related disorders, with parameters yoked to individual differences to improve outcomes in exposure-based interventions.

Investigating d-cycloserine as a potential pharmacological enhancer of an emotional bias learning procedure.

The partial N-methyl-D-aspartate receptor agonist d-cycloserine may enhance psychological therapies. However, its exact mechanism of action is still being investigated. Cognitive bias modification techniques allow isolation of cognitive processes and thus investigation of how they may be affected by d-cycloserine. We used a cognitive bias modification paradigm targeting appraisals of a stressful event, Cognitive Bias Modification-Appraisal, to investigate whether d-cycloserine enhanced the modification of appraisal, and whether it caused greater reduction in indices of psychopathology. Participants received either 250 mg of d-cycloserine ( n=19) or placebo ( n=19). As a stressor task, participants recalled a negative life event, followed by positive Cognitive Bias Modification-Appraisal training. Before and after Cognitive Bias Modification-Appraisal, appraisals and indices of psychopathology related to the stressor were assessed. Cognitive Bias Modification-Appraisal successfully modified appraisals, but d-cycloserine did not affect appraisals post-training. There were no post-training group differences in frequency of intrusions. Interestingly, d-cycloserine led to a greater reduction in distress and impact on state mood from recalling the event, and lower distress post-training was associated with fewer intrusions. Therefore, d-cycloserine may affect emotional reactivity to recalling a negative event when combined with induction of a positive appraisal style, but via a mechanism other than enhanced learning of the appraisal style.

Effect of Transcranial Direct Current Stimulation in Patients With Tinnitus: A Meta-Analysis and Systematic Review.

Subjective tinnitus is a phantom sensation experienced without any external source of sound that profoundly impacts the quality of life. Some investigations have claimed that transcranial direct current stimulation (tDCS) reduces tinnitus, but studies on tDCS have demonstrated variable results. This meta-analysis aimed to examine the effect of tDCS on patients with tinnitus. We searched for articles published through January 5, 2016, in Medline, Cochrane, EMBASE, and Google Scholar using the following keywords: tinnitus, transcranial direct current stimulation, and tDCS. The study outcomes were change in magnitude estimates of loudness (loudness), tinnitus-related distress (distress), and Tinnitus Handicap Inventory (THI). Pooled results demonstrated that tDCS did not have a beneficial effect on loudness (pooled standardized difference in means = 0.674, 95% CI, -0.089 to 1.437, P = .083). Further, the pooled results demonstrated a greater reduction in distress for the tDCS group (pooled standardized difference in means = 0.634, 95% CI, 0.021-1.247, P = .043). We conclude that the pooled results demonstrated a greater reduction in distress for groups treated with tDCS as compared with those administered a sham treatment.

An evaluation of social work services in a cancer accommodation facility for rural South Australians.

The purpose of this investigation was to evaluate the social work service at an accommodation facility for people receiving cancer treatment away from home with a focus on distress, impact of support, and type of assistance received from the social work service. Guests who stayed at the Cancer Council Lodge during June 2015 were mailed a questionnaire collecting information about level of distress upon arrival and departure, impact of support in several areas, and what the service assisted them with specifically. The sample comprised 149 guests. Social work contact (n=19) was associated with greater reduction in distress between arrival and departure compared with no contact (n=56). Contact with a social worker was associated with greater odds of agreeing or strongly agreeing that guests felt supported in 6 out of 10 areas assessed. These areas were managing the challenges related to cancer, approaching support services, asking questions of healthcare teams, accessing support services, coping with strong emotions, and understanding reactions of family and friends. The most common types of support received were emotional and informational support. This study describes some of benefits of providing social work services to people receiving cancer treatment away from home and has implications for provision of social work service resources in similar settings. Further research could investigate the impact of this service in similar settings using randomised controlled trials to better account for potential biases. Research in this area has potential to inform program development and policy.

A randomized pilot trial of a telephone-based collaborative care management program for caregivers of individuals with dementia.

Dementia care is largely provided in primary care settings. This article describes a pilot project aimed at evaluating the effectiveness of an accessible, telephone-based, patient- and caregiver (CG)-centered, collaborative care management program that involves CG education and psychosocial support in improving CG and patient outcomes. CGs (n = 75) of older veterans with dementia receiving care from Veterans Affairs (VA) Medical Center primary care practices were randomized to receive either dementia care management or usual care (UC). Of interest in this study were the frequency and severity of patients' dementia-related symptom, CG distress related to patients' behavioral and neuropsychiatric symptoms (primary outcomes), and CG coping and mastery (secondary outcomes). Adjusted, intention-to-treat longitudinal models suggest that CGs receiving care management reported significantly greater reductions in distress due to patients' dementia-related (p = .05) and neuropsychiatric (p = .01) symptoms compared with CGs in UC. Additionally, CGs in the intervention reported significantly larger improvements in their ability to cope (p = .03) and caregiving mastery (p = .03). No significant group differences were found in CG burden or patients' dementia-related symptom frequency or severity over time. Findings suggest that CGs of veterans with dementia may benefit from a telephone-delivered, care management program in improving CG-related outcomes. Further research of care management programs for CG of veterans with dementia in addressing barriers to care and reducing CG burden is warranted. These findings highlight the potential for such programs as adjuncts to dementia care offered in primary care practices. (PsycINFO Database Record

A randomised controlled trial of cognitive behaviour therapy versus non-directive reflective listening for young people at ultra high risk of developing psychosis: The detection and evaluation of psychological therapy (DEPTh) trial

BackgroundIntervention trials for young people at ultra high risk (UHR) for psychosis have shown cognitive behaviour therapy (CBT) to have promising effects on treating psychotic symptoms but have not focused on functional outcomes. We hypothesized that compared to an active control, CBT would: (i) reduce the likelihood of, and/or delay, transition to psychosis; (ii) reduce symptom severity while improving social functioning and quality of life, whether or not transition occurred. MethodThis was a single-blind randomised controlled trial for young people at UHR for psychosis comparing CBT to an active control condition, Non Directive Reflective Listening (NDRL), both in addition to standard care, with a 6month treatment phase and 12months of follow-up. Statistical analysis is based on intention-to-treat and used random effect models to estimate treatment effects common to all time-points. ResultsFifty-seven young people (mean age=16.5years) were randomised to CBT (n=30) or NDRL (n=27). Rate of transition to psychosis was 5%; the 3 transitions occurred in the CBT condition (baseline, 2months, 5months respectively). The NDRL condition resulted in a significantly greater reduction in distress associated with psychotic symptoms compared to CBT (treatment effect=36.71, standard error=16.84, p=0.029). There were no significant treatment effects on frequency and intensity of psychotic symptoms, global, social or role functioning. ConclusionOur sample was higher functioning, younger and experiencing lower levels of psychotic like experiences than other trials. The significantly better treatment effect of NDRL on distress associated with psychotic symptoms supports the recommendations for a stepped-care model of service delivery. This treatment approach would accommodate the younger UHR population and facilitate timely intervention.Trial registration: ANZCTR 12606000101583

Acceptance and mindfulness-based stress management for support staff caring for individuals with intellectual disabilities

Support staff working with individuals with intellectual disability (ID) and challenging behaviour experience high levels of work-related stress. Preliminary theoretical and experimental research has highlighted the potential suitability of acceptance and mindfulness approaches for addressing support staff stress. This study examines the effectiveness of an acceptance and mindfulness-based stress management workshop on the levels of psychological distress and well-being of support staff working with individuals with ID and challenging behaviour. Support staff (n=120) were randomly assigned to a workshop intervention condition (n=66) or to a waiting list control condition (n=54). Measurements were completed at three time points (pre-, post and 6 week follow-up) for: psychological distress, well-being, perceived work stressors, thought suppression, and emotional avoidance/psychological inflexibility. The intervention led to significantly greater reductions in distress in the intervention group than in the control group. This was largely maintained at 6 week follow-up. This effect was more pronounced amongst a subsample that had shown higher levels of psychological distress at baseline. Thought suppression was found to reduce significantly in the intervention group between post intervention and follow-up, although no significant change was found in well-being or experiential avoidance/psychological inflexibility. Overall, results demonstrated support for the effectiveness of an acceptance and mindfulness-based intervention in reducing distress.

Pilot study of a sensory room in an acute inpatient psychiatric unit

The use of sensory rooms (also known as comfort rooms) to reduce seclusion rates has generated a great deal of interest. This study examined the outcomes associated with the introduction of a sensory room in an acute inpatient psychiatric unit. Consumers rated distress and staff rated a variety of disturbed behaviours before and after each use of the room. Items used during each episode were recorded. Use of the room was associated with significant reductions in distress and improvements in a range of disturbed behaviours. Those individuals who used the weighted blanket reported significantly greater reductions in distress and clinician-rated anxiety than those who did not. No changes were noted in rates of seclusion or aggression. The sensory room was an effective intervention to ameliorate distress and disturbed behaviour, although this did not translate into reductions in overall rates of seclusion or aggression. Weighted blankets appear to be particularly useful.

The role of therapeutic alliance in substance use disorder treatment for young adults

The therapeutic alliance is deemed to be integral to psychotherapeutic interventions, yet little is known about the nature of its role in treatment for substance use disorders (SUD), especially among young people. We investigated baseline predictors of the therapeutic alliance measured midtreatment and tested whether the alliance influenced during-treatment changes in key process variables (psychological distress, motivation, self-efficacy, coping skills, and commitment to Alcoholics Anonymous/Narcotics Anonymous [AA/NA]) independent of these baseline influences. Young adults in residential treatment (N = 303; age 18–24 years) were assessed at intake, midtreatment, and discharge. Older age and higher baseline levels of motivation, self-efficacy, coping skills, and commitment to AA/NA predicted a stronger alliance. Independent of these influences, participants who developed a stronger alliance achieved greater reductions in distress during treatment. Findings clarify a role for alliance in promoting during-treatment changes through reducing distress.

The Role of Distress in Uptake and Response to Predisposition Genetic Testing: TheBMPR2Experience

This study examines psychological determinants and effects of participating in genetic testing among persons diagnosed with or at risk for developing primary pulmonary arterial hypertension. Longitudinal data were drawn from orally administered surveys with 70 affected or at-risk individuals concerning their thoughts, feelings, and decision making about testing for mutations in BMPR2. Distress was measured by use of the Impact of Events Scale. Variations in tolerance for ambiguity were also examined. Although uptake of testing was low, as is common for incompletely penetrant mutations that lack clear therapeutic interventions, we found that those who participated in testing evidenced greater reduction in distress compared to those who had not participated in testing, irrespective of test result. No differences in tolerance for ambiguity by testing status were found. Participation in genetic testing, irrespective of test results, may be particularly beneficial to individuals who may have genetic mutations and who are experiencing high levels of distress.

The impact of blood glucose monitoring on depression and distress in insulin-naïve patients with type 2 diabetes

Objective:To test whether a structured self-monitoring of blood glucose (SMBG) protocol reduces depressive symptoms and diabetes distress.Research design and methods:A 12-month, cluster-randomised, clinical trial compared patients who received a collaborative, structured SMBG, physician/patient intervention with an active control. Studied were 483 insulin naïve type 2 diabetes patients (experimental = 256, control = 227) ( ≥ 7.5% HbA1c) from 34 primary care practices (experimental = 21, control = 13). Experimental patients used a paper tool to record a 7-point SMBG profile on each of three consecutive days prior to their quarterly physician visit. Patients and physicians interpreted SMBG results to make medication and lifestyle changes.Clinical trial registration:NIH Trial Registry Number: NCT00674986.Main outcome measures:Depressive symptoms (Patient Health Questionnaire: PHQ-8), diabetes-related distress (Diabetes Distress Scale: DDS). HbA1c and SMBG frequency were assessed quarterly; data were analysed using Linear Mixed Models (LMM) for intent-to-treat (ITT) and per protocol (PP) analyses.Results:ITT analyses showed significant improvement in depression and disease-related distress among experimental and control patients from baseline to 12 months (p < 0.01 in both cases) with no between-group differences. Experimental patients displayed significantly greater reductions in distress related to regimen adherence than controls. Also, experimental patients with elevated diabetes distress or depressive symptoms at baseline showed significantly greater reductions in distress and depressive symptoms than control patients at 12 months. The greater improvement in mood in the experimental than control group was independent of improvements in glycaemic control and changes in SMBG frequency.Conclusions:Using well standardised measures, collaborative, structured SMBG leads to reductions, not increases, in depressive symptoms and diabetes distress over time, for the large number of moderately depressed or distressed type 2 patients in poor glycaemic control. Changes in affective status are independent of improvements in glycaemic control and changes in SMBG frequency for these patients.

The efficacy and psychophysiological correlates of dual-attention tasks in eye movement desensitization and reprocessing (EMDR)

This study aimed to investigate the psychophysiological correlates and the effectiveness of different dual-attention tasks used during eye movement desensitization and reprocessing (EMDR). Sixty-two non-clinical participants with negative autobiographical memories received a single session of EMDR without eye movements, or EMDR that included eye movements of either varied or fixed rate of speed. Subjective units of distress and vividness of the memory were recorded at pre-treatment, post-treatment, and 1 week follow-up. EMDR-with eye movements led to greater reduction in distress than EMDR-without eye movements. Heart rate decreased significantly when eye movements began; skin conductance decreased during eye movement sets; heart rate variability and respiration rate increased significantly as eye movements continued; and orienting responses were more frequent in the eye movement than no-eye movement condition at the start of exposure. Findings indicate that the eye movement component in EMDR is beneficial, and is coupled with distinct psychophysiological changes that may aid in processing negative memories.

Validity of the Patient-Reported Clinical Global Impression of Change as a Measure of Treatment Response in Men with Premature Ejaculation

The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and other validated PE patient-reported measures. The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty. Data from a randomized, double-blind, 24-week phase 3 trial in 1,162 men with PE who received dapoxetine (30 mg or 60 mg) or placebo on demand provided the basis for the analysis. Patients were ≥18 years, in a stable monogamous relationship for ≥6 months, met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision criteria for PE for ≥6 months, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes. The CGIC asked patients to rate improvement or worsening of their PE compared with the start of the study using a 7-point response scale; other patient-reported measures were control over ejaculation, satisfaction with sexual intercourse, interpersonal difficulty, and personal distress related to ejaculation. Stopwatch-measured IELT was recorded. Associations between CGIC and change in other measures at study end point were assessed. The magnitude of IELT increased for each category of improvement on the CGIC: 1.63, 4.03, and 7.15 minutes for slightly better, better, and much better, respectively. Higher CGIC ratings were correlated with greater improvement in control (r = 0.73), satisfaction (r = 0.62), greater reduction in distress (r = -0.52), and interpersonal difficulty (r = -0.39). Total variance accounted for was 57.4%: control (48.7%), satisfaction (4.5%), IELT (2.8%), and distress (1.15%). The analyses support the validity of the CGIC measure in men with PE. The CGIC can provide clinicians in practice with a valid and brief outcome assessment of their patient's condition.