Background
Multiple sclerosis (MS) is the most common neurological disorder in young adults. It is estimated that 2.5 million people are living with MS worldwide. Diagnosis of MS is typically between 20 and 40 years of age, three quarters of whom are female [
1]. MS has a range of consequences on mental health. Depression and anxiety have been found to be common in individuals with MS and have been reported to be at clinically high levels especially in the early stages of the illness [
2‐
4]. The lifetime prevalence of depression among individuals with MS has been found to be 50% [
5] and point prevalence rates range from 15 to 26% [
6]. Similarly, anxiety affects between 16 and 45% of the MS population [
7,
8] and has been associated with younger age of onset, disease severity, fatigue [
9] and severity of depressive symptoms [
10]. Two studies suggest that up to 36% of MS patients continue to have high levels of depressive and anxiety symptoms in the first years after diagnosis [
3,
11].
CBT for the treatment of depression in people diagnosed with MS have demonstrated significant reductions in depression. A review of seven CBT studies (individual (3 studies), group (3 studies) and by computer (1 study)) found a medium treatment effect of 0.5 SD [
12]. One study compared individual CBT with sertraline and group therapy and found that those in the CBT and the sertraline groups showed greater improvements in their levels of depression compared to those in group therapy. In addition, those in the individual CBT group displayed improvements in mood, coping, and suicidal ideas [
13]. Askey-Jones, David, Silber, Shaw and Chalder (2013) [
14] also examined the effectiveness of a CBT delivered intervention and found that CBT resulted in statistically significant decreases in depression and anxiety with large effect sizes. More recently, Fischer et al., (2015) [
15] conducted a RCT comparing a CBT based online intervention with a waitlist control group for the treatment of depression in a sample of 71 outpatients who were diagnosed with MS for a mean length of 8 years. The researchers found that those who completed the 9-week online CBT program reported lower BDI-II scores at post and 6 months follow up compared to those in a waitlist control group.
To date, there are no published studies of early provision of tailored CBT for the treatment of depression in the first five years of a MS diagnosis with interventions focused on those with established disease (greater than 8 years). There are good reasons for early provision of CBT for the treatment of depression in those newly diagnosed with MS. Firstly, the time around receiving a MS diagnosis has been shown to be when individuals experience significantly higher levels of depression and anxiety [
2,
4,
11,
16]. Two studies suggest that up to 36% of MS patients continue to have high levels of depressive and anxiety symptoms in the first two years after a diagnosis [
11] and are at greater risk of suicide [
17]. Psychological factors are likely to be contributing. For example, MS is diagnosed at a time point when individuals are typically establishing careers, relationships and families. Individuals may also be adapting to the MS diagnosis and symptoms, the burden of uncertainty and dealing with the loss of physical and cognitive functioning, changes in interpersonal relationships, social and work roles and social support and a reduction in positively reinforcing activities. Secondly, if left untreated depression will worsen and contribute to further deterioration having an impact on the course of MS [
18] resulting in exacerbation of MS relapses [
19] and contribute to higher suicide rates [
5]. Treating depression with CBT can contribute to the alteration of disease outcomes. For example, depression has been found to be related to neurological changes in the brain due to the demyelination process [
20], treatment adherence to medical advice and treatments [
21], immune functioning [
22] and MS disease exacerbation [
23]. Therefore, early provision of treatment of depression may lead to improvements in adherence with possible positive impacts on disease processes i.e., potentially reduce exacerbations and influence longer term MS progression via increased treatment adherence and reduce markers of MS inflammation and deterioration [
24]. Thirdly, studies have demonstrated that early recognition and treatment of depression can improve social function, increase productivity and decrease absenteeism in the workplace [
25]. At the social level, early intervention has been supported because the longer a person remains depressed the more strained the interpersonal and occupational roles may become.
An intervention at the time of first diagnosis, with the potential to modify the trajectory of psychological morbidity, has not been explored. In light of the burden of depression in the early stages of disease, the aims of the study were to assess the efficacy of a tailored 8-week individualized CBT intervention in the treatment of depressive symptoms (primary outcome) in individuals who are within five years of a MS diagnosis. Secondary aims were to examine improvements in levels of anxiety, fatigue, pain, sleep quality, quality of life, coping, MS illness acceptance and resilience (secondary outcomes) at post and 20 week follow up time points and evaluate satisfaction and adherence to the tailored intervention (tertiary outcome).
Results
Participants
Table
1 shows the characteristics of participants. The groups were well matched on all demographic and medical variables. All participants had relapse remitting MS and were able to walk independently without an aid. Participants were most commonly female, employed, tertiary educated, in a stable relationship, and receiving disease modifying medication. Half of the participants have been previously diagnosed with depression and almost half have previously been diagnosed with an anxiety disorder.
Table 1
Baseline demographic characteristics of MS participants in the CBT and TAU groups
Age (M, SD) | 34.60 (9.06) | 39.27 (9.93) |
Time since diagnosis in months (M, SD) | 26.20 (15.58) | 23.53 (16.06) |
Months since first MS symptoms (M, SD) | 35.54 (16.47) | 30.57 (18.68) |
Gender (n)% female | (13) 86.7% | (9) 60% |
Years of education (n)% |
Secondary | (4) 26.7% | (3) 20% |
Trade, Tafe or Diploma | (4) 26.7% | (4) 26.7% |
Undergraduate | (3) 20% | (2) 13.3% |
Postgraduate | (4) 26.7% | (6) 40% |
Employment status (n)% |
Unemployed | (4) 27% | (5) 33.3% |
Part time | (4) 27% | (4) 27% |
Full time | (7) 47% | (6) 40% |
Marital status (n)% |
Single | (2) 13% | (0) 0% |
Partnered/Married | (13) 86.6% | (15) 100% |
Ethnic background (n)% |
Australian | (11) 73% | (10) 66.6% |
Other | (4) 26.6% | (5) 33.3% |
Ambulation status (n)% |
Able to walk independently without aid | (15) 100% | (15) 100% |
MS type (n) % |
Relapse remitting | (15) 100% | (15) 100% |
Currently taking MS disease modifying medication |
Yes (n)% | (12) 80% | (10) 66.7% |
Currently taking antidepressant medication |
Yes (n)% | (6) 40% | (5) 33.3% |
How long on this medication in months (M, SD) | 24.33 (20.68) | 25.20 (15.53) |
Previously diagnosed with depression |
Yes (n)% | (8) 53.3% | (7) 46.7% |
Previously diagnosed with anxiety |
Yes (n)% | (6) 40% | (6) 40% |
Analysis of primary outcomes
Results of ANCOVAs examining group differences on primary and secondary variables at pre, post and 20 week follow up are presented in Table
2. There were no significant differences across the groups on demographic characteristics or significant differences on baseline levels of the primary and secondary outcome measures. Linear models revealed that those in the CBT group, when compared to the TAU group, had significantly lower scores on the BDI-II at post and at 20 week follow up (
ds ranging from 1.34 to 1.66).
Table 2
Results of ANCOVAs examining group differences on primary and secondary variables at pre, post and 20 week follow up
BDI-2 |
CBT | 29.80 (11.40) | 10.89 (6.19) | | | 9.33 (7.89) | | |
TAU | 28.53 (12.21) | 25.40 (10.31) | 29.17*** | 1.66 (0.83, 2.49) | 24.34 (13.54) | 18.43*** | 1.34 (0.54, 2.13) |
STAI |
CBT | 45.40 (6.26) | 33.87 (6.88) | | | 36.20 (10.77) | | |
TAU | 48.86 (11.20) | 50.46 (12.22) | 28.67*** | 1.63 (0.80, 2.45) | 45.67 (14.15) | 2.95 | 0.73 (− 0.01, 1.47) |
MFIS |
CBT | 12.13 (3.58) | 8.73 (3.58) | | | 8.06 (3.03) | | |
TAU | 12.26 (3.84) | 11.93 (4.38) | 5.89* | 0.78 (0.04, 1.52) | 11.06 (4.74) | 11.16** | 0.73 (− 0.01, 1.47) |
PES |
CBT | 17.06 (5.62) | 12.53 (6.18) | | | 11.26 (4.51) | | |
TAU | 18.80 (6.57) | 17.67 (7.05) | 3.92* | 0.75 (0.01, 1.49) | 16.80 (5.91) | 9.80** | 1.03 (0.26, 1.79) |
MSQOL mental |
CBT | 36.06 (14.81) | 63.13 (14.42) | | | 69.93 (19.64) | | |
TAU | 40.06 (17.35) | 44.20 (21.05) | 12.73*** | 1.03 (0.26, 1.79) | 49.27 (20.49) | 12.28** | 1.00 (0.24,1.76) |
MSQOL physical |
CBT | 47.39 (18.07) | 65.92 (14.66) | | | 63.32 (17.25) | | |
TAU | 43.28 (17.63) | 47.74 (19.07) | 18.26*** | 1.04 (0.28, 1.80) | 49.33 (21.32) | 7.85** | 0.70 (−0.03, 1.44) |
PSQI |
CBT | 9.00 (3.46) | 4.40 (2.09) | | | 4.80 (2.54) | | |
TAU | 9.06 (3.93) | 7.87 (2.99) | 22.02*** | 1.31 (0.52, 2.10) | 8.20 (3.60) | 11.06** | 1.06 (0.30,1.83) |
PSSS |
CBT | 63.73 (16.41) | 59.46 (13.45) | | | 62.26 (20.39) | | |
TAU | 69.40 (12.10) | 57.33 (12.48) | 15.51** | 0.96 (0.20, 1.71) | 58.86 (17.31) | 0.001 | 0.17 (−0.54, 0.89) |
RSA |
CBT | 137.29 (34.38) | 165.45 (26.30) | | | 164.10 (25.95) | | |
TAU | 146.40 (32.38) | 148.25 (32.63) | 17.98*** | 0.57 (−0.16, 1.30) | 149.53 (37.84) | 8.49** | 0.44 (−0.29, 1.16) |
Acceptance |
CBT | 30.40 (6.04) | 28.20 (3.89) | | | 27.93 (3.88) | | |
TAU | 32.13 (4.82) | 31.14 (4.78) | 2.18 | 0.66 (−0.09, 1.41) | 31.40 (5.96) | 3.01 | −0.67 (−1.39,0.08) |
Problem solving |
CBT | 6.76 (3.19) | 8.87 (3.54) | | | 8.93 (3.53) | | |
TAU | 6.73 (4.10) | 8.73 (4.31) | 0.09 | −0.46 (−1.19,0.26) | 6.81 (3.97) | 3.99* | 0.55 (−0.18,1.28) |
Avoidance |
CBT | 9.87 (4.99) | 4.20 (3.07) | | | 3.93 (2.96) | | |
TAU | 8.53 (5.22) | 7.40 (4.45) | 11.27** | 0.81 (0.05, 1.53) | 7.87 (5.24) | 9.75** | 0.90 (0.13, 1.62) |
Analysis of secondary outcomes
Linear models revealed that those in the CBT group were associated with lower post intervention and 20 week follow up STAI scores (ds ranging from 0.73 to 1.63) although this was not statistically significant (F(1, 29) = 2.95, p > 0.05) compared to the TAU group. There were significant group differences on the MFIS and PES scores at post (ds ranging from 0.75 to 0.78) and 20 week follow up (ds ranging from 0.73 to 1.03) with the CBT group showing significantly greater reductions on scores on both scales.
There were significant group differences on the MSQOL physical health composite score at post and at 20 week follow up (ds ranging from 0.70 to 1.04) and the MSQOL mental health composite score at post and at 20 week follow up (ds ranging from 1.00 to 1.03) with the CBT group showing significantly greater improvements on both scales. There was also a significant group difference on the RSA at post and at 20 week follow up (ds ranging from 0.44 to 0.57). Specifically, there were significant group differences on the RSA subscale of personal competence at post (F(1, 29) = 10.54, p < 0.001) and 20 week follow up (F(1, 29) = 8.20, p < 0.01) and on the RSA subscale of social resources at post (F(1, 29) = 17.97, p < 0.001) and at 20 week follow up (F(1, 29) = 7.70, p < 0.01).
There were significant group differences on the PSQI score at post and at 20 week follow up (ds ranging from 1.06 to 1.31). There were also significant group differences on the PSSS score at post and at 20 week follow up (ds ranging from 0.17 to 0.96). Compared to the TAU group, those in the intervention showed more MS diagnosis acceptance although this was not statistically significant. Those in the CBT group also reported significantly lower escape avoidance coping at post and at 20 week follow up and significantly higher planful problem solving coping at 20 week follow up (ds ranging from −0.46 to 0.90). No other group differences were found for the other coping styles.
Acceptance and satisfaction with the intervention
All participants in the intervention (n = 15) reported having a very strong therapeutic alliance with the psychologist (X = 102.33, SD = 9.59). All participants in the CBT intervention reported reading and completing all of the materials provided for homework and reported that the intervention was ‘very useful’, that all of the 8 intervention sessions were ‘much to very much’ useful and beneficial, that they would ‘definitely’ recommend the intervention to a close friend who had MS and that the early intervention should be offered as part of routine care straight after diagnosis. The majority of participants (12/15, 80%) reported that the intervention contained ‘enough sessions’, that they would like ‘more sessions if they experienced new problems’, that the intervention addressed their problems ‘completely’ (11/15, 73.4%) and that the sessions were ‘completely- to a large extent’ (11/15, 73.4%) as they expected them to be. Just over half of the participants reported that the intervention came ‘at the right time’ for them (8/15, 53.3%) with the other half of participants reporting that it ‘could have even been offered earlier’ (7/15, 46.7%).
Discussion
This study demonstrated that a tailored 8-week individual face-to-face CBT based intervention was effective in significantly reducing depressive symptoms in patients newly diagnosed with MS. The data suggests that those participants in the CBT intervention reported significant reductions in levels of depressive symptoms. The between group effect sizes for the BDI-II at the end of treatment was 1.66 and 1.34 at 20 weeks follow up which were well above the 0.80 cut-off for a large treatment effect [
39]. In addition, those in the CBT group reported significant reductions in level of anxiety, fatigue and pain impact on physical, cognitive and psychosocial functioning and escape avoidance coping and significant increases in MS related quality of life in both the mental and physical domains, MS illness acceptance, sleep quality, level of resilience in particular the personal competence and social resources domains, perceived social support and planful problem solving coping at both post and at the 20 week follow up assessment. The between group effect sizes at post treatment (range between 0.57 and 1.63) and at 20 weeks follow up (range between 0.44 and 1.06) strongly supported the benefits of early intervention.
Individuals in the CBT intervention reported being satisfied with the tailored 8-week intervention and adhered to the therapy. All participants found the intervention ‘acceptable’ and ‘very useful’. All participants reported that the intervention was timely, that it addressed their problems ‘completely’, met their expectations ‘completely and to a large extent’, that all materials and strategies based on CBT principles contained in all sessions were ‘much-very much’ useful and beneficial. Of note, participants indicated that the CBT intervention should be offered as part of routine care to everyone who is newly diagnosed with MS. Adherence data suggested that all participants in the CBT intervention completed all of the 8 modules including all the readings and homework and there were no drop outs suggesting individuals were self-motivated to receive the treatment. All participants also reported a strong therapeutic alliance with their therapist.
Strengths and limitations
This research has several strengths. First, this study used a randomized, controlled pilot intervention design with clearly defined outcomes, and to the best of our knowledge, the first study to test an early tailored CBT intervention for the treatment of depressive symptoms in individuals who are within five years of being diagnosed with MS. Second, the research was conducted within a large MS clinic in a hospital service increasing the likelihood that the findings may be applicable to a wider MS population. Third, the sample was homogenous in terms of age, level of ambulation, length of MS diagnosis, MS type, education level and marital status. There were some limitations to this research. As a preliminary pilot study, it had a small sample size. Only two therapists conducted the CBT intervention. The majority of the study sample was educated and employed which may limit the generalizability of the results. The study mostly relied on self-report measures and as such there is a chance that participants may under or over report their symptoms. The current study did not compare the CBT intervention to an active comparative intervention. Future research should consider comparing the current treatment to a supportive counselling intervention which may control for non-specific therapeutic effects such as time and attention from a caring health professional. This will help to determine whether the specific components included in the CBT intervention are more effective in treating depression and resulting in broader based improvements or whether the therapeutic elements of seeing a psychologist, participating in a research study or coming in for regular appointments are just as effective in producing these improvements in those newly diagnosed with MS. The assessment period was limited to 3 months and it is not known if the benefits are sustained or if further ‘top up’ therapy is required. Larger studies with extended follow up and adequate disease measures are required in order to determine if the current intervention can impact disease progression. Monitoring of treatment fidelity (treatment implementation) was not done by an independent rater and no audio recordings of therapy sessions were undertaken which did not allow for therapist competency ratings. Also there were only two clinical psychologists who undertook all assessments and provided the intervention. In addition, future trials should include blinding of psychologists undertaking assessments and those providing the intervention and have separate people involved with the generation and allocation concealment, enrollment of participants and implementation and monitoring of the intervention. Further studies are required to assess the cost effectiveness and efficacy of the tailored CBT intervention among larger samples in order to promote it as part of routine care for individuals newly diagnosed with MS.
Conclusion
The current preliminary results provide novel evidence for the benefits of early intervention for the treatment of depressive symptoms in patients newly diagnosed with MS. The tailored early CBT intervention was found to be an acceptable and effective treatment for depression in a sample of individuals newly diagnosed with MS within a hospital outpatient facility. It also had broader benefits on anxiety, fatigue and pain management, MS illness acceptance, sleep quality, MS related quality of life, coping, resilience and social support in these individuals.
Acknowledgements
We would like to thank all participants, neurologists and staff at the MS clinic at the Royal Melbourne Hospital and all the MS related websites who assisted in advertising this pilot trial.