Fatigue, Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Fatigue, Cognitive behavioral therapy, Relaxation training, Behavioral activation, Cognitive therapy
Brief summary
This prospective case series will use mixed methods to examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components (relaxation training, behavioral activation, cognitive therapy) for fatigue in people with multiple sclerosis.
Detailed description
Fatigue affects 80% of people with multiple sclerosis (PwMS), and nearly half report fatigue as their most disabling symptom. The cognitive behavioral model of MS fatigue theorizes that MS disease factors trigger fatigue, but fatigue is maintained or worsened by factors like daily stress and how PwMS react cognitively, behaviorally, physiologically, and emotionally to fatigue. In-person and telehealth cognitive behavioral therapy (CBT) for fatigue targets these factors and reactions and is one of the most effective treatments for MS fatigue. However, CBT is resource intensive, as it consists of multiple components (i.e., relaxation training, behavioral activation, cognitive therapy), requiring 8-16 hour-long sessions delivered by a specialized clinician. CBT has yet to be assessed via an integrated translational model that considers all stages, from intervention development to implementation. Thus, the active components of CBT for MS fatigue and their mechanisms are unclear and, despite the significant burden of MS fatigue, CBT for fatigue is not widely accessible due to various implementation barriers. The proposed prospective case series is the first of two project aims. The overall project aims to optimize CBT for fatigue to maximize efficacy and efficiency. It will use the Multiphase Optimization Strategy to advance scientific evidence on CBT's active components and facilitate implementation, thereby improving accessibility. The proposed prospective case series (Aim 1) will: 1. examine the feasibility and acceptability of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for fatigue in PwMS. 2. examine initial effects of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for improving fatigue in PwMS. 3. understand participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for improving fatigue in PwMS and their recommendations for improving the CBT components.
Interventions
BEHAVIORAL4-week Relaxation Training
A 4-session telehealth Relaxation Training intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis and the cognitive behavioral model of multiple sclerosis fatigue, b) treatment rationale, b) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery, and c) goal setting and problem-solving barriers focused on integrating relaxation practices into daily routine.
BEHAVIORAL4-week Behavioral Activation
A 4-session telehealth Behavioral Activation intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, and self-monitoring activity and energy, b) treatment rationale, c) identification of values/priorities to guide activities, d) activity planning, e) goal setting and problem-solving barriers to engaging in activities.
BEHAVIORAL4-week Cognitive Therapy
A 4-session telehealth Cognitive Therapy intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, self-monitoring thoughts, and core beliefs, b) treatment rationale, b) labeling thoughts as helpful, unhelpful, or neutral, c) using distraction to cope with unhelpful thoughts, d) challenging and changing unhelpful thoughts, e) problem solving barriers to coping with or changing unhelpful thoughts.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. MS diagnosis of any subtype per chart review 2. Score 4 or higher on the Fatigue Severity Scale 3. Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for 3 or more months 4. Are able to comply with study procedures and complete measures independently assessed via self-report 5. All genders 6. 18 years of age or older 7. Able to read and speak English 8. Are willing to maintain current fatigue treatment regimen for duration of study (although individuals who want to make a change to their fatigue treatment regimen will be considered eligible 3 months after making that change)
Exclusion criteria
1. Score greater than 7 on the Patient Determined Disease Steps Scale 2. Has significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener 3. Change in disease modifying medications in the prior three months assessed via self-report (although participants will be considered eligible after the 3-month window) 4. History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 30-day window) 5. Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with the Columbia-Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible) 6. Currently engaged in psychotherapy for fatigue assessed via self-report 7. Current pregnancy (although participants will be considered eligible when they are no longer pregnant) 8. Currently participating in another research study that could impact fatigue such as intervention studies targeting mood, energy management, exercise/physical activity, and diet (although participants can be screened for eligibility once they have completed the other research study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability. |
| Intervention Appropriateness | Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness. |
| Intervention Feasibility | Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Catastrophizing | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Fatigue catastrophizing will be measured by the Fatigue Catastrophizing Scale. This is a 13-item self-report questionnaire assessing negative beliefs or expectations connected to one's perceptions of fatigue via a 5-point Likert-type scale. Summed total scores range from 0 to 52, and a higher score indicates greater fatigue catastrophizing. |
| Behavioral Activation | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Behavioral activation will be measured by the Behavioral Activation for Depression Scale Short Form. This is a 9-item self-report measure. It assess the extent to which the respondent thinks they have engaged in pleasant and/or goal-directed activity over the past week via a 7-point Likert-type scale. Summed total scores range from 0 to 54, and a higher score indicates greater behavioral activation. |
| Fatigue | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Fatigue will be measured by the Modified Fatigue Impact Scale. This is a 21-item self-report questionnaire assessing fatigue-related symptoms in the previous four weeks via 5-point Likert-type scale. It yields a total score (range: 0-84) and a higher score indicates greater fatigue. |
| Global Impression of Change | Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey). | This is a single-item self-report scale that assess the perceived intervention-related change in one's activity limitations, symptoms, emotions, and overall quality of life via 7-point Likert-type scale. The score ranges from 0 to 6 and a higher score indicates greater perceived change. |
| Cognitive Behavioural Responses Questionnaire - Short Form | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | This is a 18-item self-report questionnaire consisting of five subscales assessing cognitive responses (fear avoidance beliefs, embarrassment avoidance beliefs, symptom focusing) and behavioral responses (resting or avoidance of activity, all-or-nothing behavior) to fatigue one's connected to one's perceptions of fatigue via a 5-point Likert-type scale. The summed total subscale scores range from 0 to 12, and higher scores indicate a more negative response to fatigue. |
| Participation in Social Roles and Activities | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities (PROMIS-SRA; Hahn et al., 2010). The 8-item short form version of the PROMIS-SRA assesses the perceived ability to perform one's usual social roles and activities. Items are rated on a 5-point Likert-type scale. Raw summed scores are converted to T-scores standardized to the U.S. general population (mean = 50, standard deviation = 10), with higher scores indicating better ability to participate in social roles and activities. |
| Relaxation/Serenity | Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey). | Relaxation/Serenity will be measured by the Positive and Negative Affect Schedule Serenity Subscale. This is a 3-item self-report subscale of the Positive and Negative Affect Schedule assessing perceptions of feeling of calm, relaxed, and at ease over the previous week via a 5-point Likert-type scale. The summed total score ranges from 3-15 and a higher score indicates greater feelings of relaxation/serenity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a multiple sclerosis comprehensive care center from October 2023 to August 2024.
Pre-assignment details
Thirty individuals were screened for eligibility. Seven individuals were ineligible due to MS relapse in prior 30 days (n=1), disease modifying therapy change in prior 3 months (n=1), score lower than 4 on the Fatigue Severity Scale (n=3), significant cognitive impairment (n=1), and no MS diagnosis (n=1). One individual declined to participant due to the time commitment for study participation. One individual was excluded because research staff were unable to contact them after several attempts
Participants by arm
| Arm | Count |
|---|---|
| Relaxation Training Didactic and experiential training in one or more relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery to reduce autonomic nervous system arousal. | 7 |
| Behavioral Activation Didactic material and practice focused on identification and reduction of avoidance behaviors (e.g., excessive rest) and increased engagement in valued and reinforcing activities (e.g., physical activity, social engagement). | 7 |
| Cognitive Therapy Didactic material and practice focused on identifying, challenging, and modifying inaccurate and/or unhelpful patterns of thought about the self and the world (e.g., catastrophizing the meaning and consequences of fatigue) to change unwanted behavioral patterns (e.g., excessive rest). | 7 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | Relaxation Training | Cognitive Therapy | Behavioral Activation |
|---|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 12.9 | 48.3 years STANDARD_DEVIATION 12.3 | 46.6 years STANDARD_DEVIATION 14.9 | 47.9 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 6 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 6 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 21 Participants | 7 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 14 Participants | 4 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Intervention Acceptability
Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.
Time frame: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relaxation Training | Intervention Acceptability | 4.36 Units on a scale | Standard Deviation 0.7 |
| Behavioral Activation | Intervention Acceptability | 4.64 Units on a scale | Standard Deviation 0.48 |
| Cognitive Therapy | Intervention Acceptability | 4.68 Units on a scale | Standard Deviation 0.59 |
Primary
Intervention Appropriateness
Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.
Time frame: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relaxation Training | Intervention Appropriateness | 4.14 Units on a scale | Standard Deviation 0.57 |
| Behavioral Activation | Intervention Appropriateness | 4.25 Units on a scale | Standard Deviation 0.74 |
| Cognitive Therapy | Intervention Appropriateness | 4.25 Units on a scale | Standard Deviation 0.78 |
Primary
Intervention Feasibility
Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.
Time frame: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relaxation Training | Intervention Feasibility | 4.46 Units on a scale | Standard Deviation 0.57 |
| Behavioral Activation | Intervention Feasibility | 4.39 Units on a scale | Standard Deviation 0.61 |
| Cognitive Therapy | Intervention Feasibility | 4.42 Units on a scale | Standard Deviation 0.66 |
Secondary
Behavioral Activation
Behavioral activation will be measured by the Behavioral Activation for Depression Scale Short Form. This is a 9-item self-report measure. It assess the extent to which the respondent thinks they have engaged in pleasant and/or goal-directed activity over the past week via a 7-point Likert-type scale. Summed total scores range from 0 to 54, and a higher score indicates greater behavioral activation.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Behavioral Activation | Pre-treatment | 27.14 Units on a scale | Standard Deviation 4.67 |
| Relaxation Training | Behavioral Activation | Post-treatment | 27.57 Units on a scale | Standard Deviation 10.21 |
| Behavioral Activation | Behavioral Activation | Pre-treatment | 24.86 Units on a scale | Standard Deviation 8.11 |
| Behavioral Activation | Behavioral Activation | Post-treatment | 35.43 Units on a scale | Standard Deviation 8.02 |
| Cognitive Therapy | Behavioral Activation | Pre-treatment | 29.14 Units on a scale | Standard Deviation 7.34 |
| Cognitive Therapy | Behavioral Activation | Post-treatment | 38.43 Units on a scale | Standard Deviation 6.6 |
Secondary
Cognitive Behavioural Responses Questionnaire - Short Form
This is a 18-item self-report questionnaire consisting of five subscales assessing cognitive responses (fear avoidance beliefs, embarrassment avoidance beliefs, symptom focusing) and behavioral responses (resting or avoidance of activity, all-or-nothing behavior) to fatigue one's connected to one's perceptions of fatigue via a 5-point Likert-type scale. The summed total subscale scores range from 0 to 12, and higher scores indicate a more negative response to fatigue.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Pre-treatment | 4.00 Units on a scale | Standard Deviation 2.31 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Post-treatment | 4.00 Units on a scale | Standard Deviation 2.08 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Pre-treatment | 7.57 Units on a scale | Standard Deviation 3.69 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Post-treatment | 7.71 Units on a scale | Standard Deviation 4.39 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Pre-treatment | 7.14 Units on a scale | Standard Deviation 3.34 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Post-treatment | 6.57 Units on a scale | Standard Deviation 3.1 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Pre-treatment | 4.14 Units on a scale | Standard Deviation 3.24 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Post-treatment | 4.14 Units on a scale | Standard Deviation 3.58 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Pre-treatment | 9.00 Units on a scale | Standard Deviation 2.58 |
| Relaxation Training | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Post-treatment | 8.29 Units on a scale | Standard Deviation 2.36 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Pre-treatment | 10.00 Units on a scale | Standard Deviation 2.16 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Pre-treatment | 5.57 Units on a scale | Standard Deviation 1.72 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Post-treatment | 4.00 Units on a scale | Standard Deviation 3.83 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Pre-treatment | 6.43 Units on a scale | Standard Deviation 2.15 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Post-treatment | 5.57 Units on a scale | Standard Deviation 1.62 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Post-treatment | 7.00 Units on a scale | Standard Deviation 2.38 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Post-treatment | 5.00 Units on a scale | Standard Deviation 2.71 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Pre-treatment | 6.29 Units on a scale | Standard Deviation 2.36 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Pre-treatment | 6.00 Units on a scale | Standard Deviation 3.16 |
| Behavioral Activation | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Post-treatment | 6.14 Units on a scale | Standard Deviation 4.41 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Post-treatment | 7.57 Units on a scale | Standard Deviation 3.26 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Post-treatment | 6.43 Units on a scale | Standard Deviation 3.69 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Pre-treatment | 6.00 Units on a scale | Standard Deviation 2.65 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Symptom Focusing at Post-treatment | 4.71 Units on a scale | Standard Deviation 2.21 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Pre-treatment | 9.29 Units on a scale | Standard Deviation 2.29 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Resting or Avoidance of Activity at Pre-treatment | 7.29 Units on a scale | Standard Deviation 3.59 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Pre-treatment | 6.29 Units on a scale | Standard Deviation 3.55 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | All-or-nothing Behavior at Post-treatment | 7.43 Units on a scale | Standard Deviation 3.1 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Fear Avoidance Beliefs at Post-treatment | 4.86 Units on a scale | Standard Deviation 4.26 |
| Cognitive Therapy | Cognitive Behavioural Responses Questionnaire - Short Form | Embarrassment Avoidance Beliefs at Pre-treatment | 6.14 Units on a scale | Standard Deviation 4.06 |
Secondary
Fatigue
Fatigue will be measured by the Modified Fatigue Impact Scale. This is a 21-item self-report questionnaire assessing fatigue-related symptoms in the previous four weeks via 5-point Likert-type scale. It yields a total score (range: 0-84) and a higher score indicates greater fatigue.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Fatigue | Pre-treatment | 44.29 Units on a scale | Standard Deviation 11.13 |
| Relaxation Training | Fatigue | Post-treatment | 36.14 Units on a scale | Standard Deviation 10.09 |
| Behavioral Activation | Fatigue | Pre-treatment | 49.38 Units on a scale | Standard Deviation 9.74 |
| Behavioral Activation | Fatigue | Post-treatment | 34.14 Units on a scale | Standard Deviation 12.27 |
| Cognitive Therapy | Fatigue | Pre-treatment | 54.71 Units on a scale | Standard Deviation 20.15 |
| Cognitive Therapy | Fatigue | Post-treatment | 37.29 Units on a scale | Standard Deviation 13.1 |
Secondary
Fatigue Catastrophizing
Fatigue catastrophizing will be measured by the Fatigue Catastrophizing Scale. This is a 13-item self-report questionnaire assessing negative beliefs or expectations connected to one's perceptions of fatigue via a 5-point Likert-type scale. Summed total scores range from 0 to 52, and a higher score indicates greater fatigue catastrophizing.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Fatigue Catastrophizing | Pre-treatment | 20.57 Units on a scale | Standard Deviation 9.14 |
| Relaxation Training | Fatigue Catastrophizing | Post-treatment | 19.29 Units on a scale | Standard Deviation 8.34 |
| Behavioral Activation | Fatigue Catastrophizing | Pre-treatment | 18.86 Units on a scale | Standard Deviation 17.17 |
| Behavioral Activation | Fatigue Catastrophizing | Post-treatment | 15.71 Units on a scale | Standard Deviation 11.25 |
| Cognitive Therapy | Fatigue Catastrophizing | Pre-treatment | 15.71 Units on a scale | Standard Deviation 12.79 |
| Cognitive Therapy | Fatigue Catastrophizing | Post-treatment | 11.43 Units on a scale | Standard Deviation 7.3 |
Secondary
Global Impression of Change
This is a single-item self-report scale that assess the perceived intervention-related change in one's activity limitations, symptoms, emotions, and overall quality of life via 7-point Likert-type scale. The score ranges from 0 to 6 and a higher score indicates greater perceived change.
Time frame: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relaxation Training | Global Impression of Change | 4.43 Units on a scale | Standard Deviation 0.98 |
| Behavioral Activation | Global Impression of Change | 4.29 Units on a scale | Standard Deviation 1.25 |
| Cognitive Therapy | Global Impression of Change | 4.43 Units on a scale | Standard Deviation 1.13 |
Secondary
Participation in Social Roles and Activities
Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities (PROMIS-SRA; Hahn et al., 2010). The 8-item short form version of the PROMIS-SRA assesses the perceived ability to perform one's usual social roles and activities. Items are rated on a 5-point Likert-type scale. Raw summed scores are converted to T-scores standardized to the U.S. general population (mean = 50, standard deviation = 10), with higher scores indicating better ability to participate in social roles and activities.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Participation in Social Roles and Activities | Pre-treatment | 43.23 T-score | Standard Deviation 6.09 |
| Relaxation Training | Participation in Social Roles and Activities | Post-treatment | 43.64 T-score | Standard Deviation 4.42 |
| Behavioral Activation | Participation in Social Roles and Activities | Pre-treatment | 41.39 T-score | Standard Deviation 5.44 |
| Behavioral Activation | Participation in Social Roles and Activities | Post-treatment | 46.30 T-score | Standard Deviation 7.52 |
| Cognitive Therapy | Participation in Social Roles and Activities | Pre-treatment | 40.47 T-score | Standard Deviation 7.31 |
| Cognitive Therapy | Participation in Social Roles and Activities | Post-treatment | 44.04 T-score | Standard Deviation 4.28 |
Secondary
Relaxation/Serenity
Relaxation/Serenity will be measured by the Positive and Negative Affect Schedule Serenity Subscale. This is a 3-item self-report subscale of the Positive and Negative Affect Schedule assessing perceptions of feeling of calm, relaxed, and at ease over the previous week via a 5-point Likert-type scale. The summed total score ranges from 3-15 and a higher score indicates greater feelings of relaxation/serenity.
Time frame: Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Training | Relaxation/Serenity | Pre-treatment | 9.00 Units on a scale | Standard Deviation 2.94 |
| Relaxation Training | Relaxation/Serenity | Post-treatment | 11.14 Units on a scale | Standard Deviation 1.95 |
| Behavioral Activation | Relaxation/Serenity | Pre-treatment | 8.29 Units on a scale | Standard Deviation 1.38 |
| Behavioral Activation | Relaxation/Serenity | Post-treatment | 10.00 Units on a scale | Standard Deviation 2.58 |
| Cognitive Therapy | Relaxation/Serenity | Pre-treatment | 9.57 Units on a scale | Standard Deviation 4.24 |
| Cognitive Therapy | Relaxation/Serenity | Post-treatment | 11.43 Units on a scale | Standard Deviation 1.62 |