Table 2Characteristics of Included Primary Clinical Studies

Study citation, country, funding source Study design Population characteristics Intervention and comparator(s) Clinical outcomes, length of follow-up
Feinstein et al. (2018) 9

US

Funding: William K. Warren Foundation, Epsom Salt Council, and National Institute of Health Centres of Biomedical Research Excellence

Open-label RCT, within-subject crossover design

Sample size calculation provided: No

ITT: Yes

Adults with high levels of anxiety sensitivity (N = 31)

Mean age, years (SD): 39.1 (11.1)

% Male: 38.7

Comorbidities:

  • GAD (n = 17)
  • social anxiety disorder (n = 11)
  • panic disorder (n = 9)
  • agoraphobia (n = 8)
  • PTSD (n = 11)
  • unipolar major depressive disorder (n = 29)
Condition on medication stable for 6 weeks or longer (n = 21)

Mean anxiety sensitivity, measured with ASI-3a (SD): 28.1 (12.3)

Mean anxiety severity, measured with OASISb (SD): 10.0 (3.8)

Mean depression severity, measured with PHQ-9c (SD): 11.6 (5.5)

Mean level of disability, measured with SDSd (SD): 14.7 (8.0)

Floatation-REST (float condition) (N = 15)

Exteroceptive comparator (film condition)e (N = 16)

Participants completed a 90-minute session of Floatation-REST or exteroceptive comparator. After completion of 1 condition, participants crossed over to the other condition approximately 1 week later. Both conditions were scheduled to occur at the same time of day for each participant.

Outcomes:
  • Safety and tolerability
  • State anxiety (measured with STAIf)
  • Relaxation (measured with VASg)
  • Muscle tension (measured with VASh)
  • Serenity (measured with PANAS-Xi)
  • Blood pressure
  • Interoceptive measures
Follow-up: None other than immediately after 90 minutes of treatment
Jonsson and Kjellgren (2016) 10

Sweden

Funding: Unrestricted grant from the County Council of Värmland, Sweden

Open-label RCT, parallel-group design

Sample size calculation provided: Yes

ITT: No

Adults with GAD (N = 50)

Mean age, years (SD): 43.04 (13.37)

% Male: 30

% Participants stable on medication: 40

% Participants having psychotherapy: 34

Mean pathological worry, measured with PSWQk (SD): 60.00 (10.84)

Mean GAD-symptomatology, measured with GAD-Q-IVl (SD): 9.87 (2.19)

Mean depression, measured with MADRS-Sj (SD): 22.48 (7.51)

Mean sleep difficulties, measured with PSQIm (SD): 10.17 (3.70)

Mean difficulties in emotion regulation, measured with DERSn (SD): 99.74 (20.13)

Mean mindfulness, measured with MAASo (SD): 3.29 (0.78)

Floatation-REST (N = 25)

Waitlist (N = 25)

Floatation-REST consisted of 12 sessions (45 minutes each) extending over 7 weeks with 2 sessions per week.

Outcomes:
  • Depression (measured with MADRS-Sj)
  • Pathological worry (measured with PSWQk)
  • GAD-symptomatology (measured with GAD-Q-IVl)
  • Sleep difficulties (measured with PSQIm)
  • Difficulties in emotion regulation (measured with DERSn)
  • Mindfulness (measured with MAASo)
  • Experienced deviations from normal state (measured with EDNp)
Follow-up: 6 months after the end of treatment

ASI-3 = Anxiety Sensitivity Index-3; DERS = Dysfunctional Emotional Regulation Scale; EDN = Experienced Deviation from Normal State Scale; GAD = generalized anxiety disorder; GAD-Q-IV = Generalized Anxiety Disorder Questionnaire 4th edition; ITT = intention-to-treat; MAAS = Mindful Attention and Awareness Scale; MADRS-S = Montgomery-Asberg Depression Rating Scale; OASIS = Overall Anxiety Severity and Impairment Scale; PANAS-X = Positive and Negative Affect Schedule Expanded Form; PHG-9 = Patient Health Questionnaire 9-item depression scale; PSQI = Pittsburg Sleep Quality Index; PSWQ = Penn State Worry Questionnaire; PTSD = post-traumatic stress disorder; RCT = randomized controlled trial; REST = Reduced Environmental Stimulation Therapy; SD = standard deviation; SDS = Sheehan Disability Scale; STAI = State-Trait Anxiety Inventory; VAS = visual analogue scale.

Note that this table has not been copy-edited.

a

The ASI-3 is an 18-item questionnaire with questions answered using a 4-point scale. The total ASI scores can range from 0 to 72. Healthy North Americans have a mean ASI-3 total score of 12.8 (SD = 10.6). Patients with anxiety and depression commonly have a total ASI score around 30.

b

The OASIS is a 5-item questionnaire, which is a continuous measure of anxiety severity and impairment over the past week. Each item is rated on a 5-point scale and the ratings are summed to obtain a total score ranging from 0 to 20. A cut-score of 8 has been shown to correctly classify 87% of individuals as having a current anxiety diagnosis.

c

The PHQ-9 is a 9-item measure for assessing the severity of depressive symptoms over the past 2 weeks. Scores of 1 to 4 are considered indicative of minimal depression, 5 to 9 mild depression, 10 to 14 moderate depression, 15 to 19 moderately severe depression, and 20 to 27 severe depression.

d

The SDS assesses how much the respondent’s mental health issues are perceived to have affected their daily activities in 3 functional domains: work/school, social/leisure activities, and family life/home responsibilities. Total disability scores range between 0 to 30, with scores ≥ 5 signifying impairment. Significant impairment in functioning in patients with anxiety disorders has been shown to be associated with mean total disability scores between 14 and 18.

e

Watching a nature documentary from the BBC Planet.

f

STAI is a 20-item self-report questionnaire designed to assess an individual’s level of anxiety at the present moment with total scores ranging from 20 to 80; higher scores mean higher levels of anxiety.

g

Measured on a 100-point VAS scale, from 0 (Not at all relaxed or no relaxation) to 100 (Extremely relaxed or the most relaxed I have ever felt).

h

Measured on a 100-point bipolar valence scale ranging from −50 (Extremely Unpleasant) to + 50 (Extremely Pleasant), with the slider starting in the middle of the scale at 0 (Neutral).

i

Measured using the PANAS-X, which is commonly used to measure mood. The scale has participants rate how calm, relaxed, and at ease they feel at the present moment using a 5-point Likert-type response scale, ranging from 1 (Very slightly or not at all) to 5 (extremely).

j

The 9-item MADRS-S is a Swedish self-reported assessment of depressive symptoms. The total score ranges between 0 and 54. Cut-off values have been set at: 0 to 6 = no depression; 7 to 19 = mild depression; 20 to 34 = moderate depression; and 34 or higher = severe depression.

k

The 16-item PSWQ is used to assess pathological worry. The instrument has a strong ability to differentiate patients with GAD from other anxiety disorders. Total scores range between 16 and 80. The cut-off score of 45 or higher indicates GAD.

l

The 9-item GAD-Q-IV is a self-reported measure assessing the severity of GAD as defined by the 4th edition of the Diagnostic and Statistical Manual. The measure is used as a continuous variable and the total score ranges between 0 and 12. A cut-off point of 5.7 or higher has been suggested to yield the optimal ratio between sensitivity and specificity for identifying severe GAD.

m

The 19-item PSQI is used to assess subjective sleep quality. The instrument measures sleep disturbance during the previous month. The total score ranges between 0 and 21 and distinguishes between good and poor sleep, where a score of 5 or higher indicates poor-quality sleep.

n

The 36-item DERS is a self-reported measure assessing emotion regulation difficulties. The total score ranges between 36 and 180. Higher scoring indicates greater difficulties in emotion regulation.

o

The 15-item MAAS is a self-reported measure of trait mindfulness. It assesses the level of open and receptive attention to and awareness of ongoing experience. The score ranges from 1 to 6. Higher scoring indicates greater mindfulness.

p

The EDN is a Swedish 29-item self-reported measure specifically designed to be used in floatation-REST experiments. It assesses the degree of relaxation and deviation from normal state experience during the flotation session. Each item is graded on VAS ranging from 0 to 100. A score of 30 on EDN at the first floatation session, and a score of 40 at the subsequent floatation sessions, is considered an indication of typical treatment response, in comparison with resting on a bed in a dark quiet room, which generally gives a score of 15.

From: Floatation Therapy for Mental Health Conditions

Cover of Floatation Therapy for Mental Health Conditions
Floatation Therapy for Mental Health Conditions: CADTH Health Technology Review [Internet].
Tran K, Loshak H; Authors.
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