Clinical Trial Of Cognitive-behavioral Therapy Research Articles

Trials We Cannot Trust: Investigating Their Impact on Systematic Reviews and Clinical Guidelines in Spinal Pain

We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive-behavioral therapy and exercise in spinal pain. We identified multiple concerns in 8 trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials (“index trials”) on results, conclusions, and recommendations of systematic reviews and clinical practice guidelines (CPGs). We conducted forward citation tracking using Google Scholar and the citationchaser tool, searched the Guidelines International Network library and National Institute of Health and Care Excellence archive to June 2022 to identify systematic reviews and CPGs. We explored how index trials impacted their findings. Where reviews presented meta-analyses, we extracted or conducted sensitivity analyses for the outcomes of pain and disability, to explore how the exclusion of index trials affected effect estimates. We developed and applied an ’Impact Index’ to categorize the extent to which index studies impacted their results. We included 32 unique reviews and 10 CPGs. None directly raised concerns regarding the veracity of the trials. Across meta-analyses (55 comparisons), the removal of index trials reduced effect sizes by a median of 58% (Inter Quartlie Range (IQR) 40–74). 85% of comparisons were classified as highly, 3% as moderately, and 11% as minimally impacted. Nine out of 10 reviews conducting narrative synthesis drew positive conclusions regarding the intervention tested. Nine out of 10 CPGs made positive recommendations for the intervention(s) evaluated. This cohort of trials, with concerns regarding trustworthiness, has substantially impacted the results of systematic reviews and guideline recommendations. PerspectiveWe found that a group of trials of CBT for spinal pain with concerns relating to their trustworthiness has had substantial impacts on the analyses and conclusions of systematic reviews and clinical practice guidelines. This highlights the need for a greater focus on the trustworthiness of studies in evidence appraisal. Pre-registrationOur protocol was preregistered on the Open Science Framework: https://osf.io/m92ax/

Sleep efficiency predicts improvements in fear extinction and PTSD symptoms during prolonged exposure for veterans with comorbid insomnia

Prolonged exposure (PE) is an evidenced-based psychotherapy for PTSD, but many Veterans fail to achieve a clinically meaningful response. Sleep issues are prevalent in Veterans and may interfere with PE by disrupting the learning and consolidation of fear extinction memories during PE exposures. Here, we examined whether changes in fear extinction across imaginal exposures and PTSD symptoms during PE were predicted by diary-assessed levels of nightly sleep efficiency (SE; i.e., percent of time in bed spent sleeping), which may indirectly index sleep fragmentation and sleep-facilitated memory processes. Participants were Veterans with PTSD and comorbid insomnia (N = 40) participating in a clinical trial of cognitive-behavioral therapy for insomnia plus PE. SE was measured via nightly sleep diaries, fear extinction was operationalized as a reduction in peak distress between weekly imaginal exposures, and PTSD symptoms were assessed bi-weekly. Cross-lagged panel models revealed that higher sleep efficiency during the week predicted lower peak distress at the subsequent imaginal exposure and lower PTSD symptoms at the subsequent assessment, whereas PTSD symptoms and peak distress did not predict subsequent sleep efficiency. Efficient sleep may facilitate fear extinction and PTSD reduction during PE. Targeting sleep efficiency could improve PE effectiveness for Veterans with comorbid insomnia.

Mechanisms of change in posttraumatic headache-related disability: A mediation model.

To explore whether the association between change in headache management self-efficacy and posttraumatic headache-related disability is partially mediated by achange in anxiety symptom severity. Many cognitive-behavioral therapy treatments for headache emphasize stress management, which includes anxiety management strategies;however, little is currently known about mechanisms of change in posttraumatic headache-related disability. Increasing our understanding of mechanisms could lead to improvements in treatments for these debilitating headaches. This study is a secondary analysis of veterans (N=193) recruited to participate in a randomized clinical trial of cognitive-behavioral therapy, cognitive processing therapy, or treatment as usual for persistent posttraumatic headache. The direct relationship between headache management self-efficacy and headache-related disability, along with partial mediation through change in anxiety symptoms was tested. The mediated latent change direct, mediated, and total pathways were statistically significant. The path analysis supported a significant direct pathway between headache management self-efficacy and headache-related disability (b=-0.45, p < 0.001; 95% confidence interval [CI: -0.58, -0.33]). The total effect of change of headache management self-efficacy scores on change in Headache Impact Test-6 scores was significant with a moderate-to-strong effect (b=-0.57, p=0.001; 95% CI [-0.73, -0.41]). There was also an indirect effect through anxiety symptom severity change (b=-0.12, p=0.003; 95% CI [-0.20, -0.04]). In this study, most of the improvements in headache-related disability were related to increased headache management self-efficacy with mediation occurring through change in anxiety. This indicates that headache management self-efficacy is a likely mechanism of change of posttraumatic headache-related disability with decreases in anxiety explaining part of the improvement in headache-related disability.

Empirically Defining Treatment Response and Remission in Obsessive-Compulsive Disorder Using the Obsessive-Compulsive Inventory–Revised

In clinical trials of obsessive-compulsive disorder (OCD), clinical outcomes are generally measured using lengthy clinician-administered interviews. However, in routine clinical practice, many clinicians lack the time to administer such instruments. This study evaluated cutoffs for treatment response and remission in OCD using the self-rated Obsessive-Compulsive Inventory—Revised (OCI-R). Data from 349 patients in three clinical trials of cognitive-behavioral therapy for OCD were pooled for analysis. The OCI-R was compared to gold-standard criteria for response and remission based on the clinician-administered Yale–Brown Obsessive Compulsive Scale and the Clinical Global Impression Scale. The results showed that a ≥40% reduction on the OCI-R was the optimal cutoff for treatment response, with a sensitivity of 0.72 and a specificity of 0.79. For remission status, the optimal cutoff was ≤8 points on the OCI-R, with a sensitivity of 0.57 and specificity of 0.83. Results from additional analyses using the 12-item version of the OCI were similar. These cutoffs provide a simple and time-efficient way to help determine treatment response and remission in OCD when the administration of clinician-administered instruments is unfeasible.

The evolution of patients’ concept of the alliance and its relation to outcome: A dynamic latent-class structural equation modeling approach.

The working alliance (WA) has been widely identified as the key concept for psychotherapy and allied health care services. The WA, measured at different phases of diverse kinds of therapies, has been shown to robustly predict posttreatment outcomes. But the way the clients' conceptualization of the alliance evolves overtime, and the relation between this kind of conceptual change and subsequent symptom improvements, has not been investigated. Dynamic Latent Class Structural Equation Models (DLC-SEM) were applied to data drawn from two randomized clinical trials of cognitive-behavioral therapy for generalized anxiety disorder (N = 57 and 80) to evaluate several potential models of the relation between the conceptual/structural changes in patients' self-reports of the quality of the alliance and subsequent treatment outcomes. Inspection of the DLC-SEM models suggests that, overtime, between 63% and 66% of the better session-level outcome clients switched from three factors (task, goal, bond) to an integrated single factor conceptualization of the therapeutic alliance. The study indicates that the majority of patients evolve their concept of the alliance overtime: The previously distinct alliance elements become integrated into a single factor construct. These findings suggest that if such overtime development is generalizable across diverse patient/treatment populations, future research ought to take these developments into account both methodologically (i.e., how alliance is measured) and in analyzing time-series data (e.g., using DLC-SEM). By modeling the patient's dynamic concept evolution, this initial study shows a potential to empirically explore prior theoretical propositions of the evolutions (or stability) of the alliance overtime. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A Randomized Clinical Trial of Cognitive-Behavioral Therapy for Insomnia to Augment Posttraumatic Stress Disorder Treatment in Survivors of Interpersonal Violence

Introduction: Individuals exposed to interpersonal violence (IPV) commonly develop posttraumatic stress disorder (PTSD) with co-occurring depression and insomnia. Standard PTSD interventions such as cognitive processing therapy (CPT) do not typically lead to remission or improved insomnia. Cognitive behavioral therapy for insomnia (CBTi) improves insomnia in individuals with PTSD, but PTSD severity remains elevated. Objective: To determine whether sequential treatment of insomnia and PTSD is superior to treatment of only PTSD. Methods: In a 20-week trial, 110 participants exposed to IPV who had PTSD, depression and insomnia were randomized to CBTi followed by CPT or to attention control followed by CPT. Primary outcomes following CBTi (or control) were the 6-week change in score on the Insomnia Severity Index (ISI), the Clinician-Administered PTSD Scale (CAPS), and the Hamilton Rating Scale for Depression (HAM-D). Primary outcomes following CPT were the 20-week change in scores. Results: At 6 weeks, the CBTi condition had greater reductions in ISI, HAM-D, and CAPS scores than the attention control condition. At 20 weeks, participants in the CBTi+CPT condition had greater reductions in ISI, HAM-D, and CAPS scores compared to control+CPT. Effects were larger for insomnia and for depression than for PTSD. Similar patterns were observed with respect to clinical response and remission. A tipping point sensitivity analyses supported the plausibility of the findings. Conclusions: The sequential delivery of CBTi and CPT had plausible, significant effects on insomnia, depression, and PTSD compared to CPT alone. The effects for PTSD symptoms were moderate and clinically meaningful.

IPT: From Humble Origins as ‘High Contact Therapy’ to International Adoption

IPT: From Humble Origins as ‘High Contact Therapy’ to International Adoption

Association of Neural Reward Circuitry Function With Response to Psychotherapy in Youths With Anxiety Disorders.

Identifying neural correlates of response to psychological treatment may inform targets for interventions designed to treat psychiatric disorders. This study examined the extent to which baseline functioning in reward circuitry is associated with response to psychotherapy in youths with anxiety disorders. A randomized clinical trial of cognitive-behavioral therapy compared with supportive therapy was conducted in youths with anxiety disorders. Before treatment, 72 youths (9-14 years old) with anxiety disorders and 37 group-matched healthy comparison youths completed a monetary reward functional MRI task. Treatment response was defined categorically as at least a 35% reduction in diagnostician-rated anxiety severity from pre- to posttreatment assessment. Pretreatment neural activation in the striatum and medial prefrontal cortex (mPFC) during monetary wins relative to losses was examined in relation to treatment response. Responders, nonresponders, and healthy youths differed significantly in mPFC activation to rewards versus losses at baseline. Youths with anxiety exhibited higher mPFC activity relative to healthy youths, although this may have been driven by differences in depressive symptoms. Planned comparisons between treatment responders (N=48) and nonresponders (N=24) also revealed greater pretreatment neural activation in a cluster encompassing the subgenual anterior cingulate cortex and nucleus accumbens among responders. Striatal activation to reward receipt may not differentiate youths with anxiety from healthy youths. However, higher striatal responsivity to rewards may allow youths with anxiety to improve during treatment, potentially through greater engagement in therapy. Function in reward circuitry may guide development of treatments for youths with anxiety.

Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.

Creation and validation of the Cognitive and Behavioral Response to Stress Scale in a depression trial

The Cognitive and Behavioral Response to Stress Scale (CB-RSS) is a self-report measure of the use and helpfulness of several cognitive and behavioral skills. Unlike other measures that focus on language specific to terms used in therapy, the CB-RSS was intended to tap the strategies in ways that might be understandable to those who had not undergone therapy. The measure was included in a clinical trial of cognitive-behavioral therapy for depression and completed by 325 participants at baseline and end of treatment (18 weeks). Psychometric properties of the scale were assessed through iterative exploratory and confirmatory factor analyses. These analyses identified two subscales, cognitive and behavioral skills, each with high reliability. Validity was addressed by investigating relationships with depression symptoms, positive affect, perceived stress, and coping self-efficacy. End of treatment scores predicted changes in all outcomes, with the largest relationships between baseline CB-RSS scales and coping self-efficacy. These findings suggest that the CB-RSS is a useful tool to measure cognitive and behavioral skills both at baseline (prior to treatment) as well as during the course of treatment.

Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia

The primary objective of this study was to estimate a clinically significant and quantifiable change in functional disability to identify treatment responders in a clinical trial of cognitive-behavioral therapy (CBT) for youth with juvenile fibromyalgia (JFM). The second objective was to examine whether baseline functional disability (Functional Disability Inventory), pain intensity, depressive symptoms (Children’s Depression Inventory), coping self-efficacy (Pain Coping Questionnaire), and parental pain history predicted treatment response in disability at 6-month follow-up. Participants were 100 adolescents (11–18years of age) with JFM enrolled in a recently published clinical trial comparing CBT to a fibromyalgia education (FE) intervention. Patients were identified as achieving a clinically significant change in disability (ie, were considered treatment responders) if they achieved both a reliable magnitude of change (estimated as a ⩾7.8-point reduction on the FDI) using the Reliable Change Index, and a reduction in FDI disability grade based on established clinical reference points. Using this rigorous standard, 40% of patients who received CBT (20 of 50) were identified as treatment responders, compared to 28% who received FE (14 of 50). For CBT, patients with greater initial disability and higher coping efficacy were significantly more likely to achieve a clinically significant improvement in functioning. Pain intensity, depressive symptoms, and parent pain history did not significantly predict treatment response. Estimating clinically significant change for outcome measures in behavioral trials sets a high bar but is a potentially valuable approach to improve the quality of clinical trials, to enhance interpretability of treatment effects, and to challenge researchers to develop more potent and tailored interventions.

Pain Coping but Not Readiness to Change Is Associated With Pretreatment Pain-related Functioning

The purpose of the present study was to determine if readiness to use adaptive and avoid maladaptive pain-coping skills before initiation of psychosocial treatment for chronic pain was related to reports of present coping, and whether those variables, together or separately, explained variance in pain, pain interference, and symptoms of depression. A total of 132 patients with chronic low back pain completed measures of readiness, coping, and pain-related functioning before participation in a clinical trial of cognitive-behavioral therapy for pain. Pearson correlations indicated that the content-matched subscales of readiness and coping were moderately correlated (rs between 0.30 and 0.60), and "mismatched" subscales were generally more weakly related or unrelated. None of the readiness subscales were significantly associated with variance in any of the functioning variables. However, several aspects of coping were significantly associated with functioning. Task persistence was associated with lower pain interference and symptoms of depression; asking for assistance was associated with higher pain interference; and pain-contingent rest was associated with higher pain interference. Overall, the results indicate that adaptive coping is associated with better pain-related functioning and maladaptive coping is associated with poorer functioning, whereas readiness appears to not play a significant role in patient functioning before psychosocial pain treatment. The findings support the discriminant validity of the coping and readiness measures and inform treatment conceptualization.

Journal Digest

Journal Digest

Obsessive-Compulsive Disorder in Late Life

Although obsessive-compulsive disorder (OCD) has received increasing attention, the study and treatment of OCD in late life has been neglected. The obsessions and compulsions seen with older adults do not appear to differ from the symptoms experienced by other age groups, although developmental issues might influence symptom focus (e.g., memory functioning-related obsessions). Hoarding difficulties might be prevalent in late life, although additional studies are needed. Seniors with OCD can present with comorbid psychiatric disorders, multiple general medical problems, and impaired cognitive functioning, complicating evaluation. There have not been controlled clinical trials of cognitive-behavioral therapy (CBT) for late-life OCD, although initial reports suggest older adults respond to CBT that includes age-related treatment modifications. We illustrate the challenges to assessing and treating older adults with OCD with case examples involving memory-related obsessions and clinical hoarding. The successful strategies used for adapting CBT for the treatment of late-life generalized anxiety disorder might serve as a model for advancing the study and treatment of late-life OCD.

Relationship between mental states in depression: The assimilation model perspective

Metacognitive theories describe relationships between mental-affective self-states, including the capacity of one self-state to reflect upon another self-state. The assimilation model is a metacognitive approach that understands self-states as made of traces of experiences at different levels of integration. Psychological problems are understood as impaired accessibility of certain self-states to the person's normal awareness. These states are distressing or otherwise subjectively problematic when they emerge. This exploratory study used the assimilation framework to describe mental states in 17 clients who participated in a clinical trial of cognitive-behavioral therapy for depression. Three clinically sophisticated raters examined transcripts of 1h-long psychotherapy session per client to construct qualitative descriptions of self-states and their relationship patterns in these depressed individuals. We then systematically compared and integrated these raters' descriptions of the clients' self-states. In each case, we found a conflict between two internally incompatible states: an interpersonally submissive state and an interpersonally dominant one, a pattern consistent with the model's theoretical description of depression.

Social Disinterest Attitudes and Group Cognitive-Behavioral Social Skills Training for Functional Disability in Schizophrenia

The majority of clinical trials of cognitive-behavioral therapy (CBT) for schizophrenia have used individual therapy to target positive symptoms. Promising results have been found, however, for group CBT interventions and other treatment targets like psychosocial functioning. CBT for functioning in schizophrenia is based on a cognitive model of functional outcome in schizophrenia that incorporates dysfunctional attitudes (eg, social disinterest, defeatist performance beliefs) as mediators between neurocognitive impairment and functional outcome. In this report, 18 clinical trials of CBT for schizophrenia that included measures of psychosocial functioning were reviewed, and two-thirds showed improvements in functioning in CBT. The cognitive model of functional outcome was also tested by examining the relationship between social disinterest attitudes and functional outcome in 79 people with schizophrenia randomized to either group cognitive-behavioral social skills training or a goal-focused supportive contact intervention. Consistent with the cognitive model, lower social disinterest attitudes at baseline and greater reduction in social disinterest during group therapy predicted better functional outcome at end of treatment for both groups. However, the groups did not differ significantly with regard to overall change in social disinterest attitudes during treatment, suggesting that nonspecific social interactions during group therapy can lead to changes in social disinterest, regardless of whether these attitudes are directly targeted by cognitive therapy interventions.

A Randomized Clinical Trial of Cognitive-Behavioral Therapy and Applied Relaxation for Adults With Generalized Anxiety Disorder

This randomized clinical trial compared cognitive-behavioral therapy (CBT), applied relaxation (AR), and wait-list control (WL) in a sample of 65 adults with a primary diagnosis of generalized anxiety disorder (GAD). The CBT condition was based on the intolerance of uncertainty model of GAD, whereas the AR condition was based on general theories of anxiety. Both manualized treatments were administered over 12 weekly 1-hour sessions. Standardized clinician ratings and self-report questionnaires were used to assess GAD and related symptoms at pretest, posttest, and at 6-, 12-, and 24-month follow-ups. At posttest, CBT was clearly superior to WL, AR was marginally superior to WL, and CBT was marginally superior to AR. Over follow-up, CBT and AR were equivalent, but only CBT led to continued improvement. Thus, direct comparisons of CBT and AR indicated that the treatments were comparable; however, comparisons of each treatment with another point of reference (either waiting list or no change over follow-up) provided greater support for the efficacy of CBT than AR.

Is Symptomatic Improvement in Clinical Trials of Cognitive-Behavioral Therapy for Psychosis Clinically Significant?

Although cognitive-behavioral therapy (CBT) is becoming increasingly popular as an adjunctive treatment for psychosis, few studies to date have examined the clinical (in contrast to statistical) significance of treatment gains using standardized methods. The aim of the current study was to investigate the clinical significance of symptomatic reductions reported in trials of CBT for schizophrenia and related disorders using standardized group methods of analysis. An electronic literature search identified 12 studies that met the inclusion criteria of being randomized, controlled trials that compared CBT to routine care alone or to another comparison treatment. The analysis involved the following steps. First, reliable change on symptom measures was examined. Next, the proportion of patients in each study estimated to show clinically significant symptomatic reductions (i.e., two standard deviations) was calculated. When both post-treatment and follow-up data were considered, 42% of CBT conditions compared with only 25% of comparison conditions demonstrated reliable change on at least one psychotic symptom measure per study. Proportions of clinically significant symptomatic improvement in studies showing reliable change were similar between CBT and comparison conditions. Due to the adjunctive nature of CBT for schizophrenia and the limits imposed by the evaluation of group datasets, results of the current study are considered promising but preliminary. Future trials should examine clinical significance using similar standardized methods within studies, as well as broader functional outcome measures, to provide a clearer picture of the benefits derived from this type of intervention.

Is alcohol assessment therapeutic? Pretreatment change in drinking among alcohol-dependent women.

Participants in alcohol treatment outcome studies typically undergo extensive assessment protocols to determine eligibility and provide descriptive and predictive data before beginning therapy. Changes in alcohol consumption as a result of reactivity to assessment have generally not been studied; most researchers collapse data across the pretreatment period and compare them with within-treatment and posttreatment periods. Previously we found a reduction in drinking days from 90 days prebaseline to 3 months postbaseline, with no significant additional reduction during the second 3 months of treatment, in a clinical trial of cognitive-behavioral therapy (CBT) for alcohol-dependent women. The current study examined the points at which these participants stopped or reduced their drinking during the pretreatment assessment period. As part of a randomized clinical trial of 6 months of individual or couples CBT for 102 alcoholic women, study participants were assessed briefly via a telephone screen, a 90-minute clinical intake session with their spouses, and then a 3- to 4-hour baseline research interview. Changes in drinking frequency occurred at all four points in the pretreatment assessment process, resulting in 44% of the participants becoming abstinent before the first session of treatment. A decrease in drinking quantity across the assessment period also was found. Participants who significantly reduced drinking prior to Session 1 demonstrated better drinking outcomes during and 12 months after treatment. Changes in alcohol consumption during the assessment process in treatment outcome studies should be examined in future studies, as implications abound for interpretation of results from clinical trials. Also, implications regarding the active ingredients in brief interventions and mechanisms of the therapeutic impact of alcohol assessment should be further addressed.

Cognitive-Behavioral Therapy for Somatization and Symptom Syndromes: A Critical Review of Controlled Clinical Trials

Objective: Few treatments for somatization have been proven effective. In the past decade, however, clinical trials of cognitive-behavioral therapy (CBT) have been promising. Our aim was to critically review and synthesize the evidence from these trials. Methods: A search of the Medline database from 1966 through July 1999 was conducted to identify controlled trials designed to evaluate the efficacy of CBT in patients with somatization or symptom syndromes. Results: A total of 31 controlled trials (29 randomized and 2 nonrandomized) were identified. Twenty-five studies targeted a specific syndrome (e.g. chronic fatigue, irritable bowel, pain) while 6 focused on more general somatization or hypochondriasis. Primary outcome assessment included physical symptoms, psychological distress and functional status in 28, 26 and 19 studies, respectively. Physical symptoms appeared the most responsive: CBT-treated patients improved more than control subjects in 71% of the studies and showed possibly greater improvement (i.e., a trend) in another 11% of the studies. A definite or possible advantage of CBT for reducing psychological distress was demonstrated in only 38 and 8% of studies, and for improving functional status in 47 and 26%. Group therapy and interventions as brief as 5 sessions proved efficacious. Benefits were sustained for up to 12 months. Conclusion: CBT can be an effective treatment for patients with somatization or symptom syndromes. Benefits can occur whether or not psychological distress is ameliorated. Since chronic symptoms are exceptionally common and most studies were conducted in referral populations, the optimal sequencing of CBT in treating primary care patients and the identification of those most likely to accept and respond to therapy should be further evaluated.