No-treatment Wait-list Control Research Articles

A randomised controlled trial of clinician supported vs self-help delivery of online cognitive behaviour therapy for Bulimia Nervosa

High dropout rates and poor adherence associated with digital interventions have prompted research into modifications of these treatments to improve engagement and completion rates. This trial aimed to investigate the added benefit of clinician support when paired alongside a ten-session, online cognitive behaviour therapy (CBT) self-help intervention for bulimia nervosa (BN). As part of a three-arm, phase II randomised controlled trial, 114 participants (16 years or over) with full or subthreshold BN were randomly assigned to complete the intervention in a self-help mode (with administrative researcher contact; n = 38), with adjunct clinician support (weekly 30-minute videoconferencing sessions; n = 37), or a no-treatment waitlist control (WLC; n = 39). Baseline to post-treatment (12-weeks) decreases in objective binge episode frequency were significantly greater for clinician-supported participants as compared to WLC, but not for self-help when compared to WLC. However, due to continued improvements for self-help across follow-up (24-weeks), both arms outperformed WLC when analysed as an overall rate of change across three timepoints. Clinician-supported participants outperformed self-help in regards to laxative use and dietary restraint. Our results demonstrate that good clinical outcomes can be achieved with a relatively brief online CBT-based program even in the absence of structured clinical support, indicating a possible overreliance upon clinician support as a primary adherence-facilitating mechanism.

Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial.

The aim of the study was to examine the efficacy of an unguided, self-help cognitive behavior therapy (SH-CBT) booklet on hot flush and night sweat (HFNS) problem rating, delivered in a work setting. Women aged 45 to 60 years, having 10 or more problematic HFNS a week, were recruited to a multicenter randomized controlled trial, via the occupational health/human resources departments of eight organizations. Participants were 1:1 randomized to SH-CBT or no treatment waitlist control (NTWC). The primary outcome was HFNS problem rating; secondary outcomes included HFNS frequency, work and social adjustment, sleep, mood, beliefs and behaviors, and work-related variables (absence, performance, turnover intention, and work impairment due to presenteeism). Intention-to-treat analysis was used, and between-group differences estimated using linear mixed models. A total of 124 women were randomly allocated to SH-CBT (n = 60) and NTWC (n = 64). 104 (84%) were assessed for primary outcome at 6 weeks and 102 (82%) at 20 weeks. SH-CBT significantly reduced HFNS problem rating at 6 weeks (SH-CBT vs NTWC adjusted mean difference, -1.49; 95% CI, -2.11 to -0.86; P < 0.001) and at 20 weeks (-1.09; 95% CI, -1.87 to -0.31; P < 0.01). SH-CBT also significantly reduced HFNS frequency, improved work and social adjustment; sleep, menopause beliefs, HFNS beliefs/behaviors at 6 and 20 weeks; improved wellbeing and somatic symptoms and reduced work impairment due to menopause-related presenteeism at 20 weeks, compared with the NTWC. There was no difference between groups in other work-related outcomes. A brief, unguided SH-CBT booklet is a potentially effective management option for working women experiencing problematic HFNS.

Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

BackgroundNegative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours.Method and designThis is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16).DiscussionThis study will determine the effect of yoga practice on negative affective states, cardiovascular and cognitive function in post-phase 2 cardiac rehabilitation patients. The findings may provide evidence to incorporate yoga into standardised cardiac rehabilitation programs as a practical adjunct to improve the management of psychosocial symptoms associated with cardiovascular events in addition to improving patients’ cognitive and cardiovascular functions.Trial RegistrationACTRN12612000358842

Motivational Interviewing Versus Cognitive Behavioral Group Therapy in the Treatment of Problem and Pathological Gambling: A Randomized Controlled Trial

Pathological gambling is a widespread problem with major implications for society and the individual. There are effective treatments, but little is known about the relative effectiveness of different treatments. The aim of this study was to test the effectiveness of motivational interviewing, cognitive behavioral group therapy, and a no-treatment control (wait-list) in the treatment of pathological gambling. This was done in a randomized controlled trial at an outpatient dependency clinic at Karolinska Institute (Stockholm, Sweden). A total of 150 primarily self-recruited patients with current gambling problems or pathological gambling according to an NORC DSM-IV screen for gambling problems were randomized to four individual sessions of motivational interviewing (MI), eight sessions of cognitive behavioral group therapy (CBGT), or a no-treatment wait-list control. Gambling-related measures derived from timeline follow-back as well as general levels of anxiety and depression were administered at baseline, termination, and 6 and 12 months posttermination. Treatment showed superiority in some areas over the no-treatment control in the short term, including the primary outcome measure. No differences were found between MI and CBGT at any point in time. Instead, both MI and CBGT produced significant within-group decreases on most outcome measures up to the 12-month follow-up. Both forms of intervention are promising treatments, but there is room for improvement in terms of both outcome and compliance.

Prolonged Exposure versus Eye Movement Desensitization and Reprocessing (EMDR) for PTSD rape victims

This controlled study evaluated the relative efficacy of Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR) compared to a no-treatment wait-list control (WAIT) in the treatment of PTSD in adult female rape victims (n = 74). Improvement in PTSD as assessed by blind independent assessors, depression, dissociation, and state anxiety was significantly greater in both the PE and EMDR group than the WAIT group (n = 20 completers per group). PE and EMDR did not differ significantly for change from baseline to either posttreatment or 6-month follow-up measurement for any quantitative scale.

Psychotherapy using distance technology: A comparison of face-to-face, video, and audio treatment.

This study compared selected process and outcome variables across 3 modes of psychotherapy: faceto-face, real-time video conference, and 2-way audio (analogous to telephone). Results from 80 randomly assigned clients suggested that differences in process and outcome among the 3 treatments were small and clinically promising in comparison with the untreated control group. Experimental comparisons of process and outcome in distant versus face-to-face conditions may influence the future practice of psychology. Conventional wisdom insists that, for most purposes, the therapist and client must be in the same room. Overall, our training as psychologists has emphasized face-to-face contact as the ideal. It will be interesting to discover whether this is true. Moreover, what conditions are required to establish psychological contact with another person and, in fact, what constitutes psychological contact at all, are salient questions in the age of Internet discourse (e.g., Kraut et al., 1998). These research questions are significant for therapist training, choice of treatment, and application of previous research findings. Our effort to compare face-to-face, video, and audio individual therapy addressed two aspects of substitutability. On the process side, the working alliance was examined in all three conditions. Bordin (1979) conceptualized this alliance as the emotional bond between client and therapist, the quality of client and therapist involvement in the tasks of therapy, and the amount of concordance on goals between therapist and client. Reviewing studies of the predictive validity of the alliance variable, Henry, Strupp, Schacht, and Gaston (1994) found empirical support for alliance– outcome associations no matter how outcome was measured, who measured it, or what psychotherapeutic school of thought was represented. These reviewers entertained “the hypothesis that the alliance is a causal ingredient of change” (p. 485). On the outcome side, several assessments were combined, following the advice of Strupp and Hadley (1977) that evaluation of outcome should include multiple sources of information (therapist and client) and multiple targets for change (symptom change, satisfaction level, problem resolution). As implied above, our research questions were straightforward: Does level of working alliance differ according to mode of delivery (face-to-face, audio, or video)? Does outcome differ according to mode of delivery and in comparison to a no-treatment wait-list control group?

Out-Patient Cognitive-Behavioural Treatment of Fibromyalgia: Impact on Pain Response and Health Status

OBJECTIVE: To evaluate a cognitive-behavioural out-patient program for patients with fibromyalgia syndrome.PATIENTS AND METHODS: A quasi-experimental design was used to evaluate 101 patients who participated in a four-week program that included psychological, family educational, occupational therapy and physiotherapy interventions. After discharge, patients were seen four times over one year for day-long review sessions. Five pain response scales from the Multidimensional Pain Inventory (MPI) and the Fibromyalgia Impact Questionnaire (FIQ) were used to assess treatment effects. Data were analyzed using multivariate ANOVAs followed by multiple comparisons using Tukey's honestly significant difference test.RESULTS: The overall multivariate effect for the MPI was significant (P&lt;0.0001). Subsequent multiple comparisons indicated consistent improvement in pain severity, life interference, life control, emotional distress and activity level scores at discharge, but no change during a no-treatment waiting list control interval. These effects were maintained at a 12-month follow-up with the exception of activity level. The multivariate effect across the FIQ scales was significant (P&lt;0.01). Multiple comparisons indicated that all variables except physical impairment improved at discharge. Impairment (P&lt;0.05), anxiety and well-being (P&lt;0.01) improved at follow-up compared with scores at admission.CONCLUSIONS: Pain response and health status improve following intensive cognitive-behavioural treatment. These effects persist at one year but are generally weaker than at discharge. The largest effects were on indexes that reflect emotional status and general well-being. Implications of these findings for fibromyalgia treatment programs are discussed.

The ‘pressures to change’ approach to working with the partners of heavy drinkers

The 'Pressures to Change' approach to working with the partners of drinkers is a structured procedure for promoting change in resistant drinkers. In this study 22 women and one man were randomly allocated to two treatment conditions and one no-treatment waiting list control condition in an experimental evaluation of the procedure. Group 1 was treated individually and Group 2 was treated as a group. Almost two-thirds of the drinking partners of clients in treatment made a significant move towards change, compared with none of the drinkers in the waiting list control condition.

Semantic desensitization: A paradigmatic intervention approach to anxiety disorders

Studied the effectiveness of semantic desensitization in alleviating public speaking anxiety. Thirty speech-anxious clients, matched on the severity of their problem, were assigned randomly to one of the following treatment conditions: (a) semantic desensitization; (b) attention placebo; and (c) waiting list control. The semantic desensitization group received a self-instructional, anticipatory-anxiety hierarchy paired with visually induced, relaxing, pleasant scenes. Semantic desensitization therapy resulted in significant reductions of both the affective and behavioral components of anxiety as compared to the two controls. The placebo control also showed improvement in several indices of subjective anxiety as compared to the no-treatment waiting list control. The beneficial effects of semantic desensitization therapy were maintained on follow-up.

Modifying assertive behavior in women: A comparison of three approaches

Modeling-plus-behavior rehearsal (BT), modeling-plus-behavior rehearsal-plus-rational therapy (RBT), a consciousness-raising group (CR), and a notreatment waiting list control (WL) were compared in the treatment of assertion difficulties in 64 women in an outpatient clinical setting. Both BT and RBT showed significant improvement on the content and paralinguistic scales of the behavioral measure on treated situations. These effects also generalized to nontreated situations. Only RBT showed reduction in situational anxiety. CR proved to be ineffective.

Experimental analysis of a cognitive-behavioral therapy for depression

Cognitive therapy based on the proposals of Beck (1963)and Ellis (1970),and on Bandura (1971)and Marston (1964),was compared both with a behavioral approach derived from Ferster (1965),Lazarus (1968),and Lewinsohn (1974)and with a treatment that combined these two strategies. Twenty-eight mild to moderately depressed subjects were randomly allocated to one of the three groups or a no-treatment waiting list control group. The results indicated that the three treatment groups improved significantly more than waiting list controls on all measures, and there were no differences between the cognitive therapy alone and the behavioral intervention alone on any measure. However, the combined group was more effective than the average of either of its components alone in reducing depression as measured by Beck's Depression Inventory and Dempsey's (1964)D-30 Scale, and these results were replicated with the data derived from a self-esteem and a self-acceptance variant of Kelly's (1955)Repertory Grid. Similar, but nonsignificant, trends were observed on Aitken's (1969)Visual Analogue Scale (a subjective evaluation of depressed mood),on the Multiple Affect Adjective Checklist, and on Eysenck's Personality Inventory.