|Year : 2022 | Volume
| Issue : 1 | Page : 24-32
A comparison of cognitive behavioral therapy and acceptance and commitment therapy received by patients with major depressive disorder following traumatic brain injury for emotional status and quality of life of their caregivers: A randomized controlled trial
Ali Faghihi1, Zahra Zanjani1, Abdollah Omidi1, Esmaeil Fakharian2
1 Department of Clinical Psychology, Medical Faculty, Kashan University of Medical Science, Kashan, Iran
2 Department of Neurosurgery, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran
|Date of Submission||27-Oct-2021|
|Date of Decision||20-Jan-2022|
|Date of Acceptance||10-Feb-2022|
|Date of Web Publication||25-Feb-2022|
Department of Clinical Psychology, Medical Faculty, Kashan University of Medical Science, Kashan
Source of Support: None, Conflict of Interest: None
Introduction: Caregivers of individuals who sustained a traumatic brain injury (TBI) experience psychological problems that are linked to emotional status of their injured relatives. This study intends to compare the effect of cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) received by depressed TBI survivors on their caregivers. Methods: This was a single-blind, parallel-group, randomized controlled trial conducted between September 2018 and June 2019 at a teaching hospital in Iran. Participants were the 20–60-year-old persons who provide care to TBI survivors for 1–4 years. The survivors were randomized to receive either CBT (n = 24) or ACT (n = 24), or to stay on the waiting list (WL, n = 24). The family caregivers completed Depression Anxiety Stress Scale-21 (DASS-21) and 12-Item Short-Form Health Survey (physical, SF12-PCS; mental, SF12-MCS) before, after, and 3 months following the treatments. Results: All caregivers were analyzed (completers = 83.33%). Between-group differences were not significant (Ps > 0.5; small effect sizes) except at follow-up, where the differences on DASS21-Depression (P < 0.05; Glass's Δ = −0.635; 95% confidence interval [CI]: −0.729, 0.296) and SF12-MCS (P < 0.05; Glass's Δ = 0.751; 95% CI: −0.36, 0.807) were significant between caregivers of CBT recipients and WL. Moreover, a medium effect size on SF12-PCS (P > 0.5; Glass's Δ = 0.538; 95% CI: −0.416, 0.731) and SF12-MCS (P > 0.05; Glass's Δ = 0.507; 95% CI: −0.425, 0.772) was observed between caregivers of ACT recipients and WL at follow-up. Conclusion: Treating depression in TBI survivors can affect psychological status of their family caregivers. CBT received by TBI survivors is effective for improving caregivers' depression and mental quality of life.
Keywords: Acceptance and commitment therapy, anxiety, caregivers, cognitive behavioral therapy, depression, health-related quality of life, stress, traumatic brain injury
|How to cite this article:|
Faghihi A, Zanjani Z, Omidi A, Fakharian E. A comparison of cognitive behavioral therapy and acceptance and commitment therapy received by patients with major depressive disorder following traumatic brain injury for emotional status and quality of life of their caregivers: A randomized controlled trial. Asian J Soc Health Behav 2022;5:24-32
|How to cite this URL:|
Faghihi A, Zanjani Z, Omidi A, Fakharian E. A comparison of cognitive behavioral therapy and acceptance and commitment therapy received by patients with major depressive disorder following traumatic brain injury for emotional status and quality of life of their caregivers: A randomized controlled trial. Asian J Soc Health Behav [serial online] 2022 [cited 2022 Jun 25];5:24-32. Available from: http://www.healthandbehavior.com/text.asp?2022/5/1/24/338378
| Introduction|| |
Traumatic brain injury (TBI) is a common, unexpected, critical problem that may lead to long-term or even lifelong disabilities. Individuals who sustained a TBI commonly suffer from physical, cognitive, and psychological difficulties. They often remain unemployed or face difficulties in returning to work. So many of the survivors rely on family caregivers to meet their needs such as continued care, pursuing rehabilitation, assistance in daily life activities, participation in society, and financial support. The survivors are also more vulnerable to emotional disorders, especially post-TBI major depressive disorder (P-TBI-MDD) that leads to more health and social problems as well as more caregiver burden. In addition to objective burden such as time and finances devoted to care, the caregivers experience moderate-to-severe subjective burden that refers to negative feelings caused by caregiving tasks. The subjective burden is the main correlate of caregivers' depression, anxiety, and health-related quality of life (HRQoL). Studies have shown that up to 44% of TBI caregivers suffer from depression and up to 67% of them experience anxiety,, which are considerably higher than in the general population. These emotional problems are not affected by the type of family relationship with survivors and can lead to reduced HRQoL. Furthermore, P-TBI-MDD comes with more depression and anxiety,, as well as worse HRQoL, in the caregivers.
Considering these effects on mental health of the caregivers that could also be impacting on the quality of care they offer and thus the survivor outcomes,, studies have concluded that the caregivers need long-term emotional support., Indeed, they may need professional interventions even up to 15 years after injury. The interventions can target the caregiver, survivor–caregiver dyad, or only survivor but include involvement of the caregiver. Some studies have investigated an intervention that targets the caregiver, for example, problem-solving training or cognitive-behavioral therapy (CBT),, acceptance and commitment therapy (ACT), and brain injury family intervention. Some others have evaluated interventions that do not target only the caregiver.,
Although it has been reported that caregiver-focused interventions are more likely to provide benefit than other types of interventions, evidence about impact of the interventions is inconclusive. Importantly, most caregivers do not receive intervention at all because of different reasons; some may place the survivor needs over their needs while others might be unaware of or pessimistic about such interventions. An alternative method for treatment of the caregivers could be survivor-focused interventions because improvement of the survivor can improve the mental health of the caregiver. Studies have shown that changes in cognitive, behavioral, and emotional status of TBI survivors are significant predictors of caregivers' anxiety and depression,, that are in turn associated with their HRQoL. However, available evidence does not support any gold standard for treatment of P-TBI-MDD. The strongest support exists for antidepressants and CBT. Nevertheless, antidepressants side effects overlap with TBI symptoms and thus the risk of using such medication should be considered. There are also concerns about CBT; some theories consider CBT to be a symptom-focused treatment that targets abnormal cognitions for change while the etiology of P-TBI-MDD is multifactorial. Hence, a transdiagnostic model of treatment such as ACT that aims to promote psychological flexibility, seems to be a better option for the treatment of this population and thus leads to improvement of caregiver outcomes. To our knowledge, the assumptions have not yet been examined in TBI literature.
The aim of this study was to determine if CBT or ACT received by individuals with P-TBI-MDD provides additional and different benefits in improving caregivers' depression, anxiety stress, physical HRQoL, and mental HRQoL. The hypotheses were: (1) there is a difference between CBT and control; (2) there is a difference between ACT and control; and (3) there is a difference between CBT and ACT.
| Methods|| |
This was a part of a large, single-center, with an equal allocation ratio (1:1:1), single-blind, parallel-group, superiority, with 3-month follow-up, randomized controlled trial (RCT) conducted in Iran.
Eligible participants were family caregivers of 72 patients with P-TBI-MDD. In addition to a history of head injury recorded in the hospital record, all the patients were diagnosed with MDD at baseline of the study using the structured clinical interview for DSM-5 (SCID-5). The caregivers were included in the study based on the following criteria: (1) providing care to a TBI survivor for 1–4 years; (2) being 20–60 years old; (3) completing at least 5 years of schooling; and (4) providing informed consent. Exclusion criteria were: (1) the voluntary withdrawal from the study; (2) alterations in marital status; and (3) receiving another psychological or psychiatric intervention.
The study took place at Beheshti Hospital of Kashan from September 2018 to June 2019. Kashan is a classic city in the northern part of Isfahan Province, Iran, with populations <400,000. The annual incidence rate of TBI in Kashan has been estimated to be 429 cases per 100,000 people.
Interventions were provided in hospital setting for 4 months by a clinical psychologist who had been supervised in CBT and ACT for 4 years.
Cognitive behavioral therapy
The CBT protocol for MDD commences with behavioral interventions and terminates with cognitive interventions. The first session consisted of an introduction to CBT model of depression. Sessions 2–4 are dedicated to the activity scheduling and behavioral activation. Sessions 5–14 are dedicated to cognitive interventions such as cognitive reappraisal, identifying thoughts and examining its evidence, problem-solving, and coping strategies. Relapse prevention strategies are also considered in session 14. Moreover, the protocol emphasizes between-session assignments.
Acceptance and commitment therapy
The ACT protocol for MDD focuses on promoting six core processes within Hexaflex model of psychological flexibility. The first two sessions are dedicated to acclimating patients to ACT and inducing creative hopelessness. Sessions 3–6 are devoted to promoting acceptance and defusion processes. Sessions 7–11 are dedicated to promoting commitment and behavior change processes. Furthermore, mindfulness and self as context processes are introduced through all sessions, especially 4–11. The final session is devoted to reactions to treatment termination, reviewing the strategies and techniques, and maintaining therapeutic gains. The protocol includes between-session assignments.
TBI survivors were assessed by Beck Depression Inventory-II (BDI-II) and depression subscale of Depression Anxiety and Stress Scale-21 (DASS-21) while caregivers were assessed before and after the intervention as well as at 3-month follow-up by DASS-21 and 12-Item Short-Form Health Survey (SF-12).
Beck Depression Inventory
The BDI-II is a 21-item measure of depressive symptoms. TBI survivors are asked to rate each item on a scale ranging from 0 to 3 (not present to severe) regarding the past 2 weeks. Total scores of 0–13 indicate minimal depression and total scores of 14–19, 20–28, and 29–63 are considered mild, moderate, and severe depression, respectively. The BDI-II has adequate reliability and validity, and it has been widely used for clinical and research purposes. In the present study, we used a Persian version of the BDI-II. Internal consistency of this version has been estimated between 0.73 and 0.93 (mean = 0.86) and test–retest reliability of it ranged from 0.48 to 0.86.
Depression Anxiety and Stress Scale-21
DASS-21 is a series of three reliable and valid subscales for discriminate between depression and anxiety. The third subscale, termed stress, assesses the common features of depression and anxiety. DASS-21 contains 21 items scored on a 4-point scale of 0–3 (“Did not apply to me at all” to “Applied to me very much or most of the time”). The sum of the scores on each subscale multiplied by two indicates normal, mild, moderate, severe, or extremely severe states. In the present study, we used a Persian version of the DASS-21. Test–retest reliability and internal consistency coefficients for depression (DASS21-D), anxiety (DASS21-A), and stress (DASS21-S) subscales of the version have been estimated at 0.81, 0.78, 0.80 and 0.85, 0.75, 0.87, respectively.
12-Item Short-Form Health Survey
SF-12, a valid and reliable measure of HRQoL, involves 12 items with two summary scores for health components. Participants should rate the items based on a 2-, 3-, 5-, or 6-point scale. The physical component summary (SF12-PCS) and mental component summary (SF12-MCS) are computed and transformed to a 0–100 scale (worth-best; mean = 50; standard deviation = 10) using a standard scoring algorithm. A Persian version of the SF-12 has been used in this study. For this version, the internal consistency of PCS and MCS has been estimated at 0.73 and 0.72, respectively.
Sample size estimation
During an RCT compared CBT with ACT, it was observed that the mean score and standard deviation of BDI-II in the CBT group were 4.94 and 7.21 while in the ACT group were 11.41 and 9.15. We estimated that we would need to enroll 24 patients in each group to have 80% power to detect a difference between the groups, at a two-sided alpha level of 0.05, with the following formula:
For three groups:
Considering a dropout rate of 25%:
19 + 5 = 24
Randomization and allocation
Participants were the caregivers of 72 eligible patients with P-TBI-MDD. The TBI survivors were purposively selected using medical records, and randomly assigned into three groups of CBT, ACT, and waiting list (WL) with a 1:1:1 allocation [Figure 1]. The caregivers were then grouped into three groups according to their care recipients: Group 1, the caregivers of CBT recipients; Group 2, the caregivers of ACT recipients; and Group 3, the caregivers of those who were in the WL group.
|Figure 1: Consort flow diagram. SUR: Survivor; CG: Caregiver; SCD: Survivor–caregiver dyad; ITT: Intention-to-treat analysis; PP: Per-protocol analysis|
Click here to view
Allocation sequence was created using a random number table concealed in sequentially numbered, sealed, opaque envelopes, and kept in the department of clinical psychology. Enrollment and baseline assessments were conducted by research staffs that were unaware of the allocation sequence. Envelopes were opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention.
Participants and therapist were aware of the allocated arm. Outcomes were assessed by self-report measures that obviated the need for assessor blinding. The data were collected and entered into SPSS statistical software (Statistical Product and Service Solutions version 18 for Windows; SPSS Inc., Chicago, IL, United States) by a blinded collector. All statistical analyses were performed blinded to allocation.
The study was approved by the Ethics Committee of the Kashan University of Medical Sciences (ID: IR.KAUMS.MEDNET.REC.1397.024), performed in accordance with the Declaration of Helsinki, and registered in the Iranian Registry of Clinical Trials (ID: IRCT20190115042371N1).
Intention-to-treat method was used for analyzing results. Chi-squared tests (for nominal variables), Kruskal–Wallis tests (for ordinal variables), and one-way analysis of variance (for interval variables) were used to ensure that the participants in each group are comparable on the variables at preintervention.
Outcomes were analyzed using repeated measures Analysis of Variance (rANOVA) with Bonferroni correction post hoc pairwise comparisons to explore any statistically significant difference (P < 0.05) between the test conditions. Furthermore, substantive significance was estimated using Glass's Δ and Cohen's d between-group effect sizes (ESb).
| Results|| |
Participants were recruited from September to December 2018, and the follow-up period was from April to June 2019. A total of 60 (83.33%) survivors completed the trial, but data from all randomized participants were analyzed [Figure 1].
The demographic and clinical variables of the caregivers are demonstrated in [Table 1]. There were no significant differences between the groups at preintervention on any demographic or clinical variables (Ps > 0.05), denoting sufficient randomization.
Outcomes and estimations
The care recipients reported moderate depression on BDI-II at baseline (mean of each group ≤25.05). At 3-month follow-up, those who received CBT reported minimal depression (mean <13) while ACT recipients showed mild depression (mean <17) on BDI-II. Furthermore, CBT was significantly more effective than ACT on DASS21-D (P < 0.05).
[Table 2] displays the means and standard deviations of outcome variables at three times by group, in addition to the results of rANOVA. At preintervention, all groups reported moderate depression, anxiety, and stress; and below-average HRQoL. According to the table, a significant within-subjects effect of time was obtained on all subscales (Ps < 0.05) while the between-subjects effects of group were not significant (Ps > 0.05). Importantly, the within-subjects effect of time × group was significant on DASS21-D (P < 0.001), SF12-PCS (P < 0.01), and SF12-MCS (P < 0.001).
|Table 2: Means, standard deviations, and changes in clinical variables over time by group|
Click here to view
[Table 3] demonstrates pairwise comparisons and between-group effect sizes. At postintervention, between-group differences were not significant on all subscales (Ps > 0.5). However, a small ESb (0.2< Δ <0.5) was found between caregivers of either CBT or ACT recipients and caregivers of the WL group on all subscales. A very small ESb (d < 0.2) was also found in the comparison of caregivers of CBT recipients and caregivers of ACT recipients on all subscales.
|Table 3: Pairwise comparisons and between-group effect sizes for clinical variables over time by group|
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At 3-month follow-up, the caregivers of CBT recipients showed no difference from postintervention on DASS21-A, DASS21-S, and SF12-PCS. Nevertheless, they showed a significant improvement on DASS21-D (P < 0.05; Δ = −0.635; 95% CI: −0.729, 0.296) and SF12-MCS (P < 0.05; Δ = 0.751; 95% CI: −0.36, 0.807) compared to the caregivers of the WL group. The caregivers of ACT recipients also showed no difference from post–intervention on DASS21-A, DASS21-S, and DASS21-D but a medium ESb on SF12-PCS (P > 0.5; Δ = 0.538; 95% CI: −0.416, 0.731) and SF12-MCS (P > 0.5; Δ = 0.507; 95% CI: −0.425, 0.722) compared to the caregivers of the WL group. Finally, comparison of CBT and ACT revealed similar results to postintervention on all subscales except DASS21-D (P > 0.5; d = −0.235; 95% CI: –0.627, 0.493) and SF12-MCS (P > 0.5; d = 0.235; 95% CI: −0.496, 0.632), where a small ESb was detected between the caregivers of CBT recipients and the caregivers of ACT recipients.
There was a slight increase in the mean values of all subscales when per-protocol analysis was applied. Nevertheless, there was no difference in the P values and magnitude of effect sizes compared to intention-to-treat analysis except on postintervention SF12-MCS and follow-up SF12-PCS; a medium ESb was detected between the caregivers of CBT recipients and the caregivers of the WL group on postintervention SF12-MCS (P > 0.5; Δ =0.551; 95% CI: −0.45, 0.803) and follow-up SF12-PCS (P > 0.5; Δ = 0.537; 95% CI: −0.455, 0.799).
| Discussion|| |
This study investigated the effect of CBT and ACT received by individuals with P-TBI-MDD on emotional status and HRQoL of their caregivers. The results indicated that using CBT for treating the survivors improves their caregivers, especially on DASS21-D and SF12-MCS, while using ACT is better than control condition with small-to-medium ESb.
Although we could find no RCTs addressing the effect of psychological treatments received by TBI survivors on their caregivers, some other studies support our findings. These studies have reported that P-TBI-MDD leads to greater burden, and consequently worse emotional status, and poorer HRQoL of caregivers. Hence, posttraumatic recovery of the survivor can improve the mental status of the caregiver. This is in accordance with our findings that both CBT and ACT received by individuals with P-TBI-MDD improved emotional status and HRQoL of their caregivers. However, the improvements were not significant except on DASS21-D and SF12-MCS.
The significant reduction in caregivers' depression can be explained by reduction in depression among the CBT recipients. A prospective cohort study has demonstrated that depression in the person with TBI has significant direct effects on caregiver depression. In other words, the caregiver perception of survivor depression is the best predictor for depression in caregiver. CBT targets depression through the cognitive and behavioral techniques. There is some evidence that the cognitive techniques can promote executive functions such as planning ability and problem-solving skills that in turn play an important role in depression reduction. Hence, it is plausible that in the current study, the significant improvement in the caregivers' depression may be a result of depression improvement among the CBT recipients following cognitive interventions. Another prospective cohort study has shown that cognitive changes and depression in TBI survivors have significant direct effects on caregiver depression.
In contrast, ACT has theoretically emphasized that processes such as problem-solving are based on some of the same cognitive processes that can lead to psychopathology. Hence, instead of restructuring cognitions, ACT tends to treat people who feel depressed by increasing their willingness to accept their thoughts and feelings, defuse from these private events, and engage in behavioral changes that move them toward their valuable goals. Such an approach to treating P-TBI-MDD could help reduce caregivers' anxiety more than their depression. Unlike caregiver depression, the cohort studies have reported that caregiver anxiety is affected by social and behavioral changes in the TBI survivors.,
In fact, ACT encourages patients to be aware of their values that may include social items such as connection, cooperation, and friendliness, and change their behavior to be in line with the values. However, using CBT for treating TBI survivors can also be effective on caregiver anxiety. Behavioral techniques in CBT such as activity scheduling are used as an antidote to anxiety in depressed patients that has a direct effect on caregivers' anxiety. Given that stress has clear affinities with anxiety, it is conceivable that improvement of anxiety in TBI survivors results in reduction of both anxiety and stress in caregivers. However, these reductions were not significant in the present study. This could be due to the time elapsed from injury which was 1–4 years for all participants. After an immediate increase, caregiver anxiety is reduced during the 3 months after the injury and then remains relatively stable whereas the relationship between caregiver depression and TBI symptoms gets stronger over time., Moreover, caregiver anxiety is associated with a wide range of concerns. In addition to anxiety related to a person with TBI, caregivers have anxiety that is specific to the caregiver role such as mastery of duties and level of burden experienced, and so on. In this study, neither CBT nor ACT specifically targeted these sources of caregiver anxiety.
Our findings on HRQoL can also be explained by considering depression in survivors and caregivers. In general, HRQoL of caregivers is predicted by their and survivors' depression. When the survivor depression improves, caregivers may experience less depression and consequently greater HRQoL. However, depression is strongly associated with mental but not physical component of HRQoL. Studies have identified SF12-MCS as a valid screening tool for emotional status, especially depression,, while SF12-PCS has been linked to physical health. Therefore, a significant reduction in caregivers' depression, which is predicted by decrease in depression among the CBT recipients, can result in significant improvement of mental HRQoL as measured by SF12-MCS.
This study includes some limitations. The study has not investigated caregiver-focused interventions. Therefore, the differences between the effect of such interventions and those that target care recipients remain unclear. Moreover, there are some confounders that we did not adjust for. For example, variables specific to the role or related to the psychological history of the caregiver could impact the results of this study.
Future research should investigate caregiver-focused interventions and compare the effect of such interventions with those received by survivors. Future studies should also consider confounding factors such as social support, coping strategy, history of emotional problems in the caregivers, and so on.
| Conclusion|| |
Although using psychological treatments such as CBT and ACT for treating depression in people who sustain a TBI can affect emotional status and HRQoL of their caregivers, these effects are not significant except the effect of CBT on depression and mental HRQoL.
The study was approved by the Ethics Committee of the Kashan University of Medical Sciences with the number of IR.KAUMS.MEDNET.REC.1397.024. The authors are acknowledging all the participants and those who have cooperated in the study.
Financial support and sponsorship
This study was financially supported by the Kashan University of Medical Sciences, Vice Chancellor for Research and Technology (GR-97041).
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]