Trial-Based Cognitive Therapy for depressive and anxious symptoms: A systematic review and meta-analysis of efficacy and dropout rates

Abstract

Background

With depression and anxiety disorders increasing globally, effective therapies like Trial-Based Cognitive Therapy (TBCT), a novel Cognitive-Behavioral Therapy (CBT) variant, are crucial. This systematic review and meta-analysis aim to assess TBCT's efficacy in reducing depression and anxiety symptoms and its dropout rates compared with other psychotherapies.

Methods

Comprehensive searches across databases like CENTRAL, PUBMED/MEDLINE, PsycINFO, LILACS/BVS, Clinicaltrials.gov, WHO International Clinical Trials Registry Platform, and Google Scholar were conducted. Eligibility was determined based on the trial's ability to potentially benefit from TBCT and measures of depression or anxiety symptoms using validated scales. Ten RCTs involving 1245 participants were included. The meta-analysis considered post-treatment assessments, dropout rates, and risk of bias. This study was registered on PROSPERO (CRD42021252907).

Results

We identified 10 RCTs involving 1245 participants with various conditions, including Social Anxiety Disorder, Major Depressive Disorder, Post-Traumatic Stress Disorder, and Obsessive-Compulsive Disorder. The meta-analysis of 5 RCTs found no significant difference in symptom reduction between TBCT and other first-choice psychotherapies. TBCT's dropout rates were comparable to other psychotherapies. The majority of RCTs had a low risk of bias.

Conclusions

TBCT shows comparable efficacy to other psychotherapies in both short-term symptom reduction and long-term treatment gains across various mental health conditions. Its flexibility across different settings and conditions supports its utility in diverse therapeutic contexts. Despite these promising results, more rigorous and geographically diverse studies are necessary to confirm these findings. TBCT offers a promising alternative approach in the psychotherapeutic intervention landscape for mental health disorders.

Background

Depression and anxiety disorders have become increasingly prevalent over recent years, with the COVID-19 pandemic exacerbating these conditions globally. Reports indicate that lifetime rates of anxiety disorders reach up to 34 %, and depression, 20 %. Depression and anxiety not only cause significant distress but also lead to impairments in daily functioning, absenteeism, and reduced quality of life, making them leading causes of disability worldwide. Depression, especially, carries a high risk of suicide [1], [2].

Pharmacotherapy, like Selective Serotonin Reuptake Inhibitors (SSRIs), and Cognitive-Behavioral Therapies (CBTs) such as Aaron Beck’s Cognitive Therapy (CT), Interpersonal Therapy (IPT), Behavioral Activation Therapy (BA), Acceptance and Commitment Therapy (ACT), and Mindfulness-Based Cognitive Therapy (MBCT) are considered the first-line treatments for these disorders. Understanding the factors that promote therapeutic change and impact treatment adherence is crucial to enhance the outcomes of these therapies [2].

Trial-Based Cognitive Therapy (TBCT), a novel approach derived from traditional cognitive therapy, has been introduced as a potential treatment for depression and anxiety. TBCT focuses on core beliefs and employs trial-based metaphors to address and modify dysfunctional cognitions, blending cognitive restructuring with emotional techniques. Despite showing promise and efficacy across various conditions and mental disorders in initial studies, TBCT requires further evaluation to establish its efficacy and potential advantages [3], [4].

Randomized clinical trials (RCTs) and meta-analyses contribute significantly to empirically supported psychotherapies, enabling the evaluation of manualized therapies' effects [5]. Systematic reviews and meta-analyses offer a robust assessment by pooling results from multiple studies, compensating for the limitations of individual studies in sample size, generalizability, and methodological rigor. This study undertakes a systematic review and meta-analysis to assess TBCT's preliminary efficacy in treating depression and anxiety symptoms and to compare dropout rates with other psychotherapies.

Methods

We carried out comprehensive searches across various databases and manually screened eligible papers for additional sources without language or publication status restrictions. The search terms included combinations such as "Trial-Based Cognitive Therapy" AND "Randomized Clinical Trial"; "TBCT" AND "RCT"; and "TBCT" AND "Random*". Searches covered databases like CENTRAL, PUBMED/MEDLINE, PsycINFO, LILACS/BVS, Clinicaltrials.gov, WHO International Clinical Trials Registry Platform, and Google Scholar. Grey literature searches were also conducted through several platforms. For the included articles, authors were contacted for additional data regarding publications, research protocols, and information about other ongoing TBCT clinical trials.

After retrieving 40 studies, we screened them for relevant outcome measures and included those that could potentially benefit from TBCT. Any discrepancies in the selection were discussed and resolved by the authors. This systematic review was conducted in line with the Cochrane Handbook and is registered in PROSPERO (CRD42021252907).

The review considered studies where participants with conditions potentially benefited by TBCT were assessed for depression or anxiety symptoms using validated scales. Trials that used TBCT, reported dropout rates, and had a parallel control group of any type were included. Studies were excluded from meta-analysis calculations if they lacked a control group, used a limited number of TBCT sessions, did not evaluate TBCT for psychiatric disorders, or had a high risk of bias.

TBCT typically is structured into 12 sessions over three stages: the first focuses on identifying and changing dysfunctional thoughts and assumptions; the second uses a courtroom analog strategy to modify negative core beliefs; and the third consolidates gains and encourages metacognitive awareness.

We reviewed RCTs to assess TBCT's impact on depression and anxiety symptoms, typically measured with the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI), respectively [1], [6]. When multiple measures of depression or anxiety symptoms were used, we selected the post-treatment assessments with BDI and BAI. Data for treatment dropout rates were also gathered to assess TBCT's acceptability.

Risk of bias in included studies was assessed using the Cochrane Collaboration's RoB 2.0 tool, considering six domains, including sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting, and other sources of bias.

Finally, a meta-analysis was conducted using RevMan version 5.4.1 to compute the pooled effects, generate data comparisons, and create forest plots. Effect sizes for post-treatment and follow-up data were calculated using standardized mean differences (SMD), with Cohen's convention used for effect sizes interpretation: 0.20 was considered small, 0.50 moderate, and 0.80 large. The Chi² and I² tests were used to assess heterogeneity among studies.

Results

Our systematic review and meta-analysis included 10 RCTs, assessing TBCT across multiple mental health disorders. We incorporated a total of 1245 participants, with 606 assigned to TBCT. TBCT was found to be effective in a variety of contexts: individual and group sessions, with durations varying from 10 to 18 weeks. The protocols were adapted to address each specific health problem, demonstrating TBCT's flexibility. Table 1 shows the studies included in the systematic review and meta-analysis.

Table 1.

Characteristics, comparisons, main outcomes, sample size and dropout rates of included studies.

Study	Comparisons	Conditions and disorders	Mains outcomes	Weeks of treatment	Total sample size	Sample size randomized		Dropout: n (%)		Age M (SD)		Women: n and % of total sample
						TBCT	Control*	TBCT	Control*	TBCT	Control*
De Oliveira et al., 2012 [6]#	TBCT vs. CBT	SAD	LSAS and BAI	12	47	25	22	9 (36)	8 (36.3)	33.9 (9.9)	34.9 (13.4)	27 (57.4 %)
Betancur et al., (unsubmitted)	TBCT vs. TAU	HIV/AIDS	BDI and BAI	12	47	24	23	10 (41.6)	6 (26)	42.96 (8.93)	46.64 (13.05)	33 (70.2 %)
Caetano et al., 2018 [7]	TBCT vs. Waitlist	SAD	SPIN and BDI	16	62	27	35	9 (33.3)	14 (40)	28.00 (5.02)	30.00 (5.73)	29 (46.7 %)
Hemanny et al., 2019 [1]#	TBCT vs. BA and TAU	MDD	HAM-D, BDI and BAI	12	76	26	24	13 (50)	10 (41.6)	39.6 (10.4)	40.9 (11.0)	66 (86.8 %)
Thomé et al. (unsubmitted)	G-TBCT vs. FPG and TGF	Stuttering	OASES-A and BAI	12	59	20	20	7 (35)	5 (25)	30.4 (8.8)	32.3 (10.4)	15 (25.4 %)
Neufeld et al., 2020 [8]#	TBCT vs. G-CBT* vs. Waitlist	SAD	SPIN, BDI and BAI	16	86	26	27	10 (38.4)	9 (33.3)	27.08 (5.24)	28.56 (5.24)	27 (31.3 %)
Duran et al., 2020 [9]#	TBCT vs. PE	PTSD	DTS, BDI and BAI,	13	95	44	51	6 (13.6)	17 (33.3)	43.63 (12.56)	40.11 (12.38)	76 (80 %)
Reis et al. (unsubmitted)	G-TBCT vs. no intervention	School adolescents	RCADS and MSLSS	18	684	367	317	51 (13.8)	24 (7.5)	14.11 (1.79)	14.65 (1.96)	357 (52.1 %)
Rodrigues et al., 2022 [10]#	TBCT vs. ERP	OCD	Y-BOCS, BDI and BAI	12	26	12	14	3 (25)	1 (7.1)	32.4 (13.9)	33.0 (11.1)	16 (61.5 %)
Fiorentino et al., (unsubmitted)	G-TBCT vs. no intervention	Medical students	PSWQ and BDI	10	63	35	28	8 (22.8)	15 (53.7)	23.00 (2.73)	23.77 (3.77)	43 (68.2 %)

BAI: Beck Anxiety Inventory; BDI: Beck Depression Inventory; BA: Behavioral Activation; CBT: Cognitive-Behavior Therapy; DTS: Davidson Trauma Scale; ERP: Exposure and Response Prevention; FPG: Fluence Promotion Group; G-TBCT: TBCT group format; HAM-D: Hamilton Depression Rating Scale; LSAS: Liebowitz Social Anxiety Scale; MDD: Major Depressive Disorder; MSLSS: Multidimensional Student's Life Satisfaction Scale; OASES-A: Overall Assessment of the Speaker's Experience of Stuttering - Adults; OCD: Obsessive-Compulsive Disorder; PE: Prolonged Exposure; PSWQ: Penn State Worry Questionnaire; PTSD: Post-Traumatic Stress Disorder; RCADS: Revised Children's Anxiety and Depression Scale; SAD: Social Anxiety Disorder; SPIN: Social Phobia Inventory; TAU: Treatment as Usual; TBCT: Trial-Based Cognitive Therapy; TGF: Therapeutic Group in Fluency; Y-BOCS: Yale-Brown Obsessive-Compulsive Scale.

^#Studies included in meta-analysis synthesis.

We then narrowed down to 5 RCTs [6], [7], [8], [9], [10], involving 330 patients (133 received TBCT), for our meta-analysis. These RCTs diagnosed patients with mental disorders such as Social Anxiety Disorder [6], Post-Traumatic Stress Disorder [9], Major Depressive Disorder [1], and Obsessive-Compulsive Disorder [10]. Standard scales and weekly supervision ensured therapist adherence to psychotherapy protocols.

Our findings indicated that TBCT, when compared to other psychotherapies, showed no significant differences in reducing depressive symptoms (4 RCTs, n = 204, SMD = − 0.07, 95 % CI = − 0.35 to 0.20, p = 0.61). Similarly, no significant difference was found in reducing anxiety symptoms (5 RCTs, n = 237, SMD = − 0.14, 95 % CI = − 0.40 to 0.12, p = 0.28). These controls included traditional CBT, behavioral activation, prolonged exposure, and exposure and response prevention.

In terms of long-term efficacy, two studies demonstrated TBCT's comparable performance in maintaining anxiety symptom reduction after 12 months of follow-up. The analysis included two RCTs, with 62 patients (SMD = − 1.44, 95 % CI = − 3.06 to 0.19, p = 0.08). However, the heterogeneity between these studies was high (I² = 86 %).

Lastly, TBCT's dropout rate was 30.8 %, which was not significantly different from the dropout rate for other psychotherapies at 32.6 % (5 RCTs, n = 271, RR = 0.96, 95 % CI = 0.65–1.53, p = 0.87). Despite some heterogeneity (I² = 36 %, p = 0.29), these results suggest a comparable acceptance and adherence to TBCT relative to other therapies.

Overall, these results illustrate TBCT's comparable efficacy to other psychotherapies, both in the short-term symptom reduction and long-term treatment gains, across multiple mental health conditions. Furthermore, TBCT shows an adaptable and flexible approach in different settings and conditions, supporting its potential utility in diverse therapeutic contexts.

Discussion

The results of our systematic review and meta-analysis highlight the comparable efficacy of TBCT to other psychotherapies in managing a broad spectrum of mental disorders. Although TBCT did not show a superior reduction in depressive and anxiety symptoms, its performance was equivalent to existing therapies, demonstrating its potential as an alternative therapeutic option. The adaptability of TBCT to individual or group formats, as well as its applicability across varied health problems, reinforces its versatility.

The follow-up data showed that the benefits of TBCT were not transient but sustained over a 12-month period, albeit the high heterogeneity between these studies necessitates caution while interpreting these results. The comparable dropout rates between TBCT and other therapies suggest that TBCT is well-received and adhered to by patients, which is an essential aspect of the therapeutic process [3].

Despite these promising results, the presence of a high risk of bias in two studies and some concerns in four other studies underscore the need for more rigorous RCTs in the future. Furthermore, the substantial participation of TBCT developer and the preponderance of trials conducted in Brazil may present potential bias in the study outcomes. Consequently, diversifying geographical representation in future trials is crucial for more generalizable results.

To advance TBCT research, future studies should explore different settings and therapeutic combinations and compare TBCT with other popular therapeutic approaches. Long-term follow-up studies are also required to evaluate the durability of TBCT's effects. Furthermore, investigating TBCT's effects on other psychological constructs, such as quality of life or cognitive distortions, would provide a more holistic understanding of TBCT's impacts on mental health. Overall, TBCT appears to be a promising and flexible approach in the psychological intervention landscape [2].

Conclusions

In conclusion, this systematic review and meta-analysis found that TBCT is comparably effective to other psychotherapies in treating various mental health disorders. TBCT's versatility in application across different conditions and its comparable dropout rates suggest it is well-accepted by patients. Although promising, more rigorous and geographically diverse studies are necessary to strengthen these findings. Future investigations should explore TBCT's impact on other psychological constructs and its long-term effects. Conclusively, TBCT offers a promising alternative or complementary approach in the psychotherapeutic intervention landscape for mental health disorders [5].

CRediT authorship contribution statement

CH analyzed and interpreted the data. COS collected data to support the theoretical framework. FTLM assessed the risk of bias. TM supervised the data analysis and agreement on the risk of bias. All authors read and approved the final manuscript.

Ethics approval and consent to participate

Not applicable.

Funding

This study has no funding.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Availability of Data and Materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.