Dataset Information

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

ABSTRACT:

Objective

This randomized controlled pilot study investigated the feasibility of a future full-scale RCT to compare the effects of intolerance-of-uncertainty therapy (IUT) and metacognitive therapy (MCT) in primary health care patients with generalized anxiety disorder (GAD). Preliminary treatment effects were also evaluated.

Materials and methods

64 patients with GAD at a large primary health care center in Stockholm, Sweden, were randomized to IUT or MCT. Feasibility outcomes included participant recruitment and retention, willingness to receive psychological treatment, and therapists' competence in and adherence to treatment protocols. Self-reported scales were used to assess treatment outcomes, including worry, depression, functional impairment, and quality of life.

Results

Recruitment was satisfactory, and dropout was low. On a scale from 0 to 6, participants were satisfied with participating in the study (M = 5.17, SD = 1.09). Following brief training, therapists' competence was rated as moderate, and adherence was rated as weak to moderate. From pre- to post-treatment, reductions on the primary treatment outcome measure of worry were of a large effect size and statistically significant in both the IUT and MCT conditions (Cohen's d for IUT = -2.69, 95% confidence interval [-3.63, -1.76] and d for MCT = -3.78 [-4.68, -2.90]). The between-group effect size from pre- to post-treatment was large and statistically significant (d = -2.03 [-3.31, -0.75]), in favor of the MCT condition.

Conclusion

It is feasible to carry out a full-scale RCT to compare the effects of IUT to MCT for patients with GAD in primary health care. Both protocols seem effective, and MCT seems superior to IUT, but a full-scale RCT is needed to confirm these conclusions.

Trial registration

ClinicalTrials.gov (no. NCT03621371).

SUBMITTER: Af Winklerfelt Hammarberg S

PROVIDER: S-EPMC10266649 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

Af Winklerfelt Hammarberg Sandra S Toth-Pal Eva E Jansson-Fröjmark Markus M Lundgren Tobias T Westman Jeanette J Bohman Benjamin B

PloS one 20230614 6

<h4>Objective</h4>This randomized controlled pilot study investigated the feasibility of a future full-scale RCT to compare the effects of intolerance-of-uncertainty therapy (IUT) and metacognitive therapy (MCT) in primary health care patients with generalized anxiety disorder (GAD). Preliminary treatment effects were also evaluated.<h4>Materials and methods</h4>64 patients with GAD at a large primary health care center in Stockholm, Sweden, were randomized to IUT or MCT. Feasibility outcomes in ...[more]

PMID: 37315099

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Project description:BackgroundIntolerance of uncertainty (IU) is considered as a specific risk factor in the development and maintenance of generalized anxiety disorder (GAD). Yet, researches have investigated the relations between IU and GAD (or worry) using total scores on self-report measures. This ignores that there are different components exist in IU and the heterogeneity of GAD symptoms. In the present study, we explored the relations among different components of IU and symptoms of GAD.MethodsA dimensional approach which take individual differences into consideration in different components of IU along a full range of normal to abnormal symptom severity levels of GAD were used in this study. Components of IU were measured by 12-item Intolerance of Uncertainty Scale and symptoms of GAD were measured by Generalized Anxiety Disorder 7-Item Questionnaire. Regularized partial-correlation network was estimated using cross-sectional data from 624 university students.ResultsFour strongest edges are between components of IU, like "Unforeseen events upset me greatly" and "It frustrates me not having all the information I need". Two strongest edges are between symptoms of GAD, like "Being so restless that it is hard to sit still" and "Feeling afraid as if something awful might happen". Symptom "Worrying too much about different things" and component "It frustrates me not having all the information I need" have the highest expected influences in the present network. In the community of IU, component "It frustrates me not having all the information I need" has the highest bridge expected influence. And in the community of GAD, symptoms "Worrying too much about different things" and "Not being able to stop or control worrying" have the highest bridge expected influence.ConclusionsThis study reveals potential pathways between different components of IU and various symptoms of GAD. Understanding how putative risk factors such as different components of IU are related to symptoms of GAD may provide some references for related preventions and interventions, such as targeting component "It frustrates me not having all the information I need" may be more effective at reducing symptoms of GAD than targeting other components of IU.

Project description:BackgroundAt present, the use of repetitive transcranial magnetic stimulation (rTMS) for generalized anxiety disorder (GAD) is limited to single-site interventions. We investigated whether dual-site frontoparietal stimulation delivered using cortical-cortical paired associative stimulation (ccPAS) had stronger clinical efficacy than single-site stimulation in patients with GAD.MethodsWe randomized 50 patients with GAD to 1 Hz rTMS (10 sessions) using 1 of the following protocols: single-site stimulation over the right dorsolateral prefrontal cortex (dlPFC; 1500 pulses per session); single-site stimulation over the right posterior parietal cortex (PPC; 1500 pulses per session); repetitive dual-site ccPAS (rds-ccPAS) over the right dlPFC and right PPC with 1500 pulses per session (rd-ccPAS-1500); or rds-ccPAS over the right dlPFC and right PPC with 750 pulses per session (rd-ccPAS-750). Both rds-ccPAS treatments used a between-site interval of 100 ms.ResultsClinical scores for anxiety, depression and insomnia were reduced in all 4 groups after treatment. We found greater improvements in anxiety symptoms in the rds-ccPAS-1500 group compared to the rds-ccPAS-750 and single-site groups. We found greater improvements in depression symptoms and insomnia in the rds-PAS-1500 group compared to the single-site groups. The rds-ccPAS-1500 group also showed significant or trend-level improvements in anxiety symptoms and insomnia at 10-day and 1-month followup. More patients responded to treatment with rds-ccPAS-1500 than with single-site stimulation. The between-group differences in response rates persisted to the 3-month follow-up. Treatment using rds-ccPAS with a between-site interval of 100 ms induced a more significant improvement than the between-site interval of 50 ms we evaluated in a previous study.LimitationsThese results need to be replicated in a larger sample using sham control and equal-pulse single-site stimulation.ConclusionFrontoparietal rds-ccPAS may be a better treatment option for GAD.

Project description:Cognitive behavior therapy (CBT) can be effective for late-life generalized anxiety disorder (GAD), but only pilot studies have been conducted in primary care, where older adults most often seek treatment.To examine effects of CBT relative to enhanced usual care (EUC) in older adults with GAD in primary care.Randomized clinical trial recruiting 134 older adults (mean age, 66.9 years) from March 2004 to August 2006 in 2 primary care settings. Treatment was provided for 3 months; assessments were conducted at baseline, posttreatment (3 months), and over 12 months of follow-up, with assessments at 6, 9, 12, and 15 months.Cognitive behavior therapy (n = 70) conducted in the primary care clinics. Treatment included education and awareness, motivational interviewing, relaxation training, cognitive therapy, exposure, problem-solving skills training, and behavioral sleep management. Patients assigned to receive EUC (n = 64) received biweekly telephone calls to ensure patient safety and provide minimal support.Primary outcomes included worry severity (Penn State Worry Questionnaire) and GAD severity (GAD Severity Scale). Secondary outcomes included anxiety ratings (Hamilton Anxiety Rating Scale, Beck Anxiety Inventory), coexistent depressive symptoms (Beck Depression Inventory II), and physical/mental health quality of life (12-Item Short Form Health Survey).Cognitive behavior therapy compared with EUC significantly improved worry severity (45.6 [95% confidence interval {CI}, 43.4-47.8] vs 54.4 [95% CI, 51.4-57.3], respectively; P < .001), depressive symptoms (10.2 [95% CI, 8.5-11.9] vs 12.8 [95% CI, 10.5-15.1], P = .02), and general mental health (49.6 [95% CI, 47.4-51.8] vs 45.3 [95% CI, 42.6-47.9], P = .008). There was no difference in GAD severity in patients receiving CBT vs those receiving EUC (8.6 [95% CI, 7.7-9.5] vs 9.9 [95% CI, 8.7-11.1], P = .19). In intention-to-treat analyses, response rates defined according to worry severity were higher following CBT compared with EUC at 3 months (40.0% [28/70] vs 21.9% [14/64], P = .02).Compared with EUC, CBT resulted in greater improvement in worry severity, depressive symptoms, and general mental health for older patients with GAD in primary care. However, a measure of GAD severity did not indicate greater improvement with CBT.clinicaltrials.gov Identifier: NCT00308724.

Dataset Information

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

Objective

Materials and methods

Results

Conclusion

Trial registration

Publications

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

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